By Mike Havrilla on 2/17/09
The table at my website link below includes 40 companies in the ETF Innovators Global Stem Cell and Regenerative Medicine Index, which represents an expansion of the Emerging Stem Cell Index I have written about previously. The expanded global index includes companies with market caps less than $1B at the index inception with a total market value of $3,814 as of the close today. As previously, I will track the total market value for a more comprehensive gauge of investor sentiment toward the space.
http://www.etfinnovators.com/2009/02/global-stem-cell-and-regenerative.html
The index is down 16.2% over the past year on an equal-weight basis, compared to losses of 21.4% for the Healthcare Sector SPDR (XLV), 6.6% for iShares Nasdaq Biotech (IBB), 3.2% for SPDR S&P Biotech (XBI), 17.8% for PowerShares Biotech & Genome (PBE), and 41.4% for the S&P 500 SPDR (SPY).
Below is a profile for each company, including a summary of their business and research focus along with website links.
Intercytex Group PLC (UK: ICX.L) (ICYXF.PK) is a regenerative medicine company which is developing cell-based therapies for commercialization as skin and hair repair + regeneration. The Company is developing VAVELTA in Phase 2 trials for skin damage repair and facial rejuvenation; ICX PRO in a pivotal Phase 3 trial for wound healing; ICX SKN in a Phase 1 trial as a skin graft substitute; and ICX TRC in a Phase 2 trial to regenerate hair for male pattern baldness.
ReNeuron Group PLC (UK: RENE.L) (RNUGF.PK) is a UK-based adult stem cell company which will be conducting clinical studies with lead stem cell therapy candidate (ReN001) for disabled stroke patients. The Company also offers a range of stem cell lines for non-therapeutic applications, including ReNcell products for use in academic and commercial research. The ReNcellCX and ReNcellVM neural cell lines are marketed globally by Millipore (MIL).
Integra LifeSciences (IART) is a medical instrument and surgical implant company with regenerative medicine operations that focus on orthopaedic (bone grafts + regeneration) and dermal (skin regeneration + wound care) applications.
Osiris Therapeutics (OSIR) is an adult stem cell company which is developing product candidates derived from bone marrow. Prochymal is being evaluated in Phase 3 clinical trials for Graft versus Host Disease (GvHD) + Crohn's disease and in earlier stage trials for diabetes and heart attack. Chondrogen is being evaluated in a Phase 1/2 clinical trial for pain/arthritis of the knee.
Geron (GERN) is a human embryonic stem cell (hESC) company which received FDA approval in January 2009 to begin human testing in a Phase 1 clinical trial of GRNOPC1 for the treatment of acute spinal cord injuries.
Orthovita (VITA) develops bio-materials and medical instruments for orthopaedic and spinal surgery applications. The Company offers Vitoss as a synthetic bone graft for injury repair; Vitagel to control bleeding during surgery (derived from a patient's own plasma combined with collagen and thrombin); Imbibe is a family of disposable equipment used to harvest regenerative cells from a patient's bone marrow and to deliver bone grafts; and Cortoss is being evaluated in clinical trials in the U.S. as a bone augmentation bio-material.
Kensey Nash (KNSY) is a medical device maker which is focused on cardiovascular products and bio-materials for orthopaedic applications, including a partnership with Orthovita (VITA) for combinations with the Vitoss bone graft.
Alseres Pharma (ALSE) is a regenerative medicine company focused on developing new treatments for spinal cord injuries (Cethrin – a recombinant protein) and a new molecular imaging diagnostic agent (Altropane) to differentiate Parkinson's disease from other types of tremors.
Stem Cell Sciences (UK: STEM.L) is a supplier of cells and related technology to enable regenerative medicine research specializing in human embryonic and mouse neural stem cells.
Stem Cell Authority (SCAL.PK) provides cell banking and preservation services for a newborn's Mirachymal (mesenchymal – develop into muscle, bone, and other connective tissues) and Hematopoietic (develop into blood cells and components) stem cells, derived from inside the umbilical cord and within the cord blood.
Stem Cell Therapy International (SCII.OB) is a regenerative medicine company which focuses on stem cell transplants and biological solutions.
EpiStem (UK: EHP.L) is an epithelial stem cell company focused on gastrointestinal disorders, oncology, and dermatology applications. The Company also provides preclinical contract research services and is not involved with embryonic stem cells or stem cell transplants.
MediStem (MEDS.PK) is an adult stem cell company focused on endometrial regenerative cells (ERC), which specialize in generating new blood vessels (angiogenesis). ERC-142 is a compound being developed for the treatment of critical limb ischemia (lack of blood supply) to improve blood supply in order to avoid tissue death and amputation.
StemCells (STEM) engages in clinical and preclinical research and development for human neural stem cells and liver engrafting cells. Earlier stage preclinical work is focused on spinal cord injuries, myelin, and retinal disorders.
BioMimetic Therapeutics (BMTI) develops regenerative medicine device/therapeutic combination products for bio-therapeutic applications for orthopedic/spine, sports medicine, and dental procedures.
RTI Biologics (RTIX) is a provider of bio-implants and grafts to promote healing and repair for orthopedic/spinal applications, sports medicine, bone graft substitutes, and cardiovascular applications.
Cytori Therapeutics (CYTX) is a commercial-stage regenerative medicine company which is developing the Celution System to process a patient's own fat (adipose) tissue in about one hour for a variety of reconstructive and cosmetic medicine therapeutic applications.
CYTX also offers StemSource Cell Banking for a patient to preserve their own adipose-derived stem + regenerative cells (ADRCs) for use in the future as ongoing clinical trials establish the safety and effectiveness for cardiovascular disease, breast reconstruction/augmentation, liver disease, kidney failure, orthopedic/spinal disc regeneration, and gastrointestinal disorders.
CYTX currently offers its products and services in Japan and Europe along with two key strategic partners – Olympus Corp. (OCPNY.PK) (a strategic investor + medical device partner for Celution System) and Green Hospital Supply (GHSPF.PK) (a strategic investor + partner for StemSource Cell Banking, initially targeting hospitals in Japan).
Aastrom Biosciences (ASTM) is developing autologous (derived from the patient) cell products for the repair and regeneration of human tissue. Aastrom's Tissue Repair Cell (TRC) technology utilizes a patient's own bone marrow as the source of progenitor and stem cells for use in cardiac and vascular tissue regeneration.
Mesoblast (MBLTY.PK) (Australia: MSB.AX) is an adult stem cell company focused on commercializing RepliCart for bone and cartilage repair and regeneration, with recent approval to conduct a Phase 2 clinical trial for knee osteoarthritis. Mesoblast also has a U.S. subsidiary focused on cardiovascular applications for its regenerative medicine technology.
BioTime (BTIM.OB) offers blood plasma expanders such as Hextend along with its Embryome Sciences subsidiary, which includes 11 new cell lines that will be marketed to universities and bio-pharma companies for use in research programs focused on developing new cell-based therapies for neurodegenerative disease, muscular dystrophy, heart disease, cancer, and arthritis, as well as other potential applications in the emerging field of regenerative medicine.
Osteotech (OSTE) provides OsteoBiologic solutions for regenerative medicine applications to repair and replace bone loss caused by trauma or disease, augment prosthetic implant procedures, facilitate spinal fusion, and replace/repair damaged ligaments and tendons.
Neuralstem (CUR) manufactures human neural stem cells for research grant and collaborative programs and outsources the manufacturing and storage of its stem cells for use in pre-clinical studies to Charles River Labs (CRL).
RegeneRx Biopharma (RGN) has developed three drug product candidates based on a peptide molecule (Thymosin beta 4), which demonstrates promise for a variety of tissue and organ repair applications. RGN-137 is a topical gel product for healing chronic dermal wounds. RGN-259 is an eye drop for ophthalmic injuries. RGN-352 is an injectable treatment for heart attacks.
ThermoGenesis (KOOL) is a commercial-stage provider of systems for the storage and processing of adult stem cells derived from cord blood and bone marrow. KOOL offers the AutoXpress Platform (AXP) (cord blood processing) as a family of automated devices which includes the MarrowXpress (bone marrow processing) and related disposables as a closed system to process and collect adult stem cells.
The CryoSeal FS System produces fibrin sealants from blood in about one hour for use in liver resection surgeries. KOOL also expects to enter the veterinary stem cell market under the Vantus brand and plans to launch Res-Q (a system for real-time processing of bone marrow and platelet rich plasma processing) during its fiscal 4Q09 as the Company hopes to achieve profitability during 2010.
Athersys (ATHX) collaborates with Angiotech Pharma (ANPI) to develop MultiStem for the treatment of damage caused by heart attacks, peripheral vascular disease, and strokes in addition to support for stem cell transplants.
Advanced Cell Technology (ACTC.PK) focuses on human embryonic and adult stem cell technology, with FDA approval to begin Phase 2 clinical trials for adult stem cell technologies, which are focused on cardiovascular disease and transplants.
International Stem Cell Corp (ISCO.OB) offers a unique technology technology, Parthenogenesis, which results in the creation of pluripotent (ability to differentiate into a variety of unique cell types) human stem cell lines from unfertilized human eggs. ISCO's technology has the potential to eliminate the rejection of stem cell transplants, avoid ethical issues by eliminating the need for fertilized embryos, and produce specialized cells for research applications.
Bioheart (BHRT) recently secured private financing commitments for up to $7M and recently announced a grant-funded study in Italy for the Bioheart A&C Bio Science Twin-Pulsatile Life Support System which is expected to be completed within just 45 days with the potential for $2.1M in contract sales if results are positive.
BHRT develops devices and biological therapeutics for the diagnosis, treatment, and monitoring of cardiovascular disease and heart failure. MyoCell is the Company's lead product candidate, which represents a muscle-derived stem cell therapy designed to improve heart function by replacing scar tissue with living cells to restore function.
Pluristem Therapeutics (PSTI) has developed a pipeline of product candidates derived from the human placenta and processed by the Company's PluriX bio-reactor as allogeneic (ready-to-use, non-personalized cell therapy products). The Company's pipeline includes product candidates for the treatement of peripheral artery disease (PLX-PAD), inflammatory bowel disease (PLX-IBD), multiple sclerosis (PLX-MS), bone marrow transplants (PLX-BMT), and ischemic stroke (PLX-STROKE).
HepaLife Technologies (HPLF.OB) cell-based technologies under development include an artificial liver device (HepaMate), in-vitro toxicology and pre-clinical drug testing platforms, and cell-culture based vaccine production methods for the manufacture of vaccines against H5N1 avian influenza and other viruses.
Stem Cell Innovations (SCLL.PK) is a develop-stage company focused on its C3A human liver cell line for the production of human serum proteins, including the clotting factors, Factor VIII and Factor IX, used by hemophiliacs to allow their blood to clot.
Isolagen (ILE) develops products for skin and tissue rejuvenation which are designed to improve the appearance of skin injured by the effects of aging, sun exposure, acne, and burn scars using a patient’s own (autologous) fibroblast cells produced by its Isolagen Process for therapeutic and cosmetic medicine applications.
CellCyte Genetics (CCYG.OB) is a development-stage company focused on cell expansion and cell maintenance through the use of its patented bioreactor technology. The Company’s therapeutic focus is on investigative collaborations to research and develop compounds to allow the safe and efficient non-invasive delivery of stem cells through the patient’s own circulatory system to a diseased or damaged organ.
Cryo-Cell (CCEL.OB) offers cellular processing and cryogenic storage, with a focus on the collection and preservation of umbilical cord blood stem cells as a family cord blood stem cell bank and preserves the specimens in commercially available cryogenic storage equipment.
Brainstorm Cell Therapeutics (BCLI.OB) is a development-stage company focused on focused on using a patient’s own bone marrow stem cells to generate neuron-like cells that provide treatment for Parkinson’s Disease (PD), Amyotrophic Lateral Sclerosis (ALS) and spinal cord injuries.
Opexa Therapeutics (OPXA) develops autologous (patient-derived) cell-based therapies to treat multiple sclerosis (MS), rheumatoid arthritis (RA), and diabetes based on the Company’s T-cell and adult stem cell technologies. Opexa's lead product candidate is Tovaxin (a T-cell based therapeutic vaccine) for MS which is in a Phase 2b clinical trial.
Neostem (NBS) operates a commercial, autologous (patient-derived) adult stem cell bank for the pre-disease collection, processing and long-term storage of stem cells from adult donors that they can access for their own future medical treatment. The Company manages a network of adult stem cell collection centers throughout the U.S. and conducts research to identify and isolate rare stem cells from bone marrow.
Bio-Matrix Scientific Group (BMSN.OB) is a provider of disposable instruments and medical devices which are used in stem cell extraction and tissue transfer procedures and also operates cryogenic stem cell banking facilities.
Cord Blood America (CBAI.OB) preserves umbilical cord blood stem cells through a quick and non-invasive procedure at the time of birth. CBAI is focused on marketing initiatives to increase awareness of their services, which literally represent a once in a lifetime opportunity to collect and preserve cord blood stem cells which can be used in the future to treat dozens of conditions with the promise of even more medical breakthroughs with the FDA ruling to allow human stem cell testing and pending federal funding for stem cell research.
Stem Cell Therapeutics (Canada: SSS.V) is a regenerative medicine company that seeks to use drug-based treatments to stimulate a patient's existing stem cells in order to treat a variety of neurological conditions. The Company's pipeline includes lead compound NTx-265 for acute stroke, NTx-428 for traumatic brain injury, and NTx-488 for multiple sclerosis.
Tuesday, February 17, 2009
Sunday, February 15, 2009
Stem Cell Index Down 7% in Past Week
By Mike Havrilla on 2/15/09
The table at my website link below includes 26 companies in the ETF Innovators Emerging Stem Cell Index, which lost 7% of its market value in the past week (at 1,148 today) and posted a 15.2% loss over the past year on an equal-weight basis.
http://www.etfinnovators.com/2009/02/stem-cell-index-down-7-in-past-week.html
Results for benchmark indexes and ETFs include gains of 1.5% for the Cosmetic and Restorative Medicine Index and losses of 1.2% for SPDR S&P Biotech (XBI), 18.7% for Healthcare Sector SPDR (XLV), 7.2% for iShares Nasdaq Biotech (IBB), and 17.7% for PowerShares Biotech & Genome (PBE).
The next catalyst expected for stem cell and regenerative medicine companies is federal funding for stem cell research, which has been blocked by the previous administration for the past eight years. Look for an announcement soon to provide an upside catalyst for these companies now that the economic stimulus plan is expected to be finalized by Tuesday.
The decline in stem cell stocks over the past week was led by Geron (GERN), which declined by nearly 20% on Friday after the Company sold over 7M shares in a financing deal that will close on 2/19/09. Below is a summary and website links for the 26 companies included in the ETF Innovators Emerging Stem Cell Index, which are now featured at http://www.biomedreports.com/.
StemCells (STEM) engages in clinical and preclinical research and development for human neural stem cells and liver engrafting cells. Earlier stage preclinical work is focused on spinal cord injuries, myelin, and retinal disorders.
BioMimetic Therapeutics (BMTI) develops regenerative medicine device/therapeutic combination products for bio-therapeutic applications for orthopedic/spine, sports medicine, and dental procedures.
RTI Biologics (RTIX) is a provider of bio-implants and grafts to promote healing and repair for orthopedic/spinal applications, sports medicine, bone graft substitutes, and cardiovascular applications.
Cytori Therapeutics (CYTX) is a commercial-stage regenerative medicine company which is developing the Celution System to process a patient's own fat (adipose) tissue in about one hour for a variety of reconstructive and cosmetic medicine therapeutic applications.
CYTX also offers StemSource Cell Banking for a patient to preserve their own adipose-derived stem + regenerative cells (ADRCs) for use in the future as ongoing clinical trials establish the safety and effectiveness for cardiovascular disease, breast reconstruction/augmentation, liver disease, kidney failure, orthopedic/spinal disc regeneration, and gastrointestinal disorders.
CYTX currently offers its products and services in Japan and Europe along with two key strategic partners – Olympus Corp. (OCPNY.PK) (a strategic investor + medical device partner for Celution System) and Green Hospital Supply (GHSPF.PK) (a strategic investor + partner for StemSource Cell Banking, initially targeting hospitals in Japan).
Aastrom Biosciences (ASTM) is developing autologous (derived from the patient) cell products for the repair and regeneration of human tissue. Aastrom's Tissue Repair Cell (TRC) technology utilizes a patient's own bone marrow as the source of progenitor and stem cells for use in cardiac and vascular tissue regeneration.
Mesoblast (MBLTY.PK) (Australia: MSB.AX) is an adult stem cell company focused on commercializing RepliCart for bone and cartilage repair and regeneration, with recent approval to conduct a Phase 2 clinical trial for knee osteoarthritis. Mesoblast also has a U.S. subsidiary focused on cardiovascular applications for its regenerative medicine technology.
BioTime (BTIM.OB) offers blood plasma expanders such as Hextend along with its Embryome Sciences subsidiary, which includes 11 new cell lines that will be marketed to universities and bio-pharma companies for use in research programs focused on developing new cell-based therapies for neurodegenerative disease, muscular dystrophy, heart disease, cancer, and arthritis, as well as other potential applications in the emerging field of regenerative medicine.
Osteotech (OSTE) provides OsteoBiologic solutions for regenerative medicine applications to repair and replace bone loss caused by trauma or disease, augment prosthetic implant procedures, facilitate spinal fusion, and replace/repair damaged ligaments and tendons.
Neuralstem (CUR) manufactures human neural stem cells for research grant and collaborative programs and outsources the manufacturing and storage of its stem cells for use in pre-clinical studies to Charles River Labs (CRL).
RegeneRx Biopharma (RGN) has developed three drug product candidates based on a peptide molecule (Thymosin beta 4), which demonstrates promise for a variety of tissue and organ repair applications. RGN-137 is a topical gel product for healing chronic dermal wounds. RGN-259 is an eye drop for ophthalmic injuries. RGN-352 is an injectable treatment for heart attacks.
ThermoGenesis (KOOL) is a commercial-stage provider of systems for the storage and processing of adult stem cells derived from cord blood and bone marrow. KOOL offers the AutoXpress Platform (AXP) (cord blood processing) as a family of automated devices which includes the MarrowXpress (bone marrow processing) and related disposables as a closed system to process and collect adult stem cells.
The CryoSeal FS System produces fibrin sealants from blood in about one hour for use in liver resection surgeries. KOOL also expects to enter the veterinary stem cell market under the Vantus brand and plans to launch Res-Q (a system for real-time processing of bone marrow and platelet rich plasma processing) during its fiscal 4Q09 as the Company hopes to achieve profitability during 2010.
Athersys (ATHX) collaborates with Angiotech Pharma (ANPI) to develop MultiStem for the treatment of damage caused by heart attacks, peripheral vascular disease, and strokes in addition to support for stem cell transplants.
Advanced Cell Technology (ACTC.PK) focuses on human embryonic and adult stem cell technology, with FDA approval to begin Phase 2 clinical trials for adult stem cell technologies, which are focused on cardiovascular disease and transplants.
International Stem Cell Corp (ISCO.OB) offers a unique technology technology, Parthenogenesis, which results in the creation of pluripotent (ability to differentiate into a variety of unique cell types) human stem cell lines from unfertilized human eggs. ISCO's technology has the potential to eliminate the rejection of stem cell transplants, avoid ethical issues by eliminating the need for fertilized embryos, and produce specialized cells for research applications.
Bioheart (BHRT) recently secured private financing commitments for up to $7M and recently announced a grant-funded study in Italy for the Bioheart A&C Bio Science Twin-Pulsatile Life Support System which is expected to be completed within just 45 days with the potential for $2.1M in contract sales if results are positive.
BHRT develops devices and biological therapeutics for the diagnosis, treatment, and monitoring of cardiovascular disease and heart failure. MyoCell is the Company's lead product candidate, which represents a muscle-derived stem cell therapy designed to improve heart function by replacing scar tissue with living cells to restore function.
Pluristem Therapeutics (PSTI) has developed a pipeline of product candidates derived from the human placenta and processed by the Company's PluriX bio-reactor as allogeneic (ready-to-use, non-personalized cell therapy products). The Company's pipeline includes product candidates for the treatement of peripheral artery disease (PLX-PAD), inflammatory bowel disease (PLX-IBD), multiple sclerosis (PLX-MS), bone marrow transplants (PLX-BMT), and ischemic stroke (PLX-STROKE).
HepaLife Technologies (HPLF.OB) cell-based technologies under development include an artificial liver device (HepaMate), in-vitro toxicology and pre-clinical drug testing platforms, and cell-culture based vaccine production methods for the manufacture of vaccines against H5N1 avian influenza and other viruses.
Stem Cell Innovations (SCLL.PK) is a develop-stage company focused on its C3A human liver cell line for the production of human serum proteins, including the clotting factors, Factor VIII and Factor IX, used by hemophiliacs to allow their blood to clot.
Isolagen (ILE) develops products for skin and tissue rejuvenation which are designed to improve the appearance of skin injured by the effects of aging, sun exposure, acne, and burn scars using a patient’s own (autologous) fibroblast cells produced by its Isolagen Process for therapeutic and cosmetic medicine applications.
CellCyte Genetics (CCYG.OB) is a development-stage company focused on cell expansion and cell maintenance through the use of its patented bioreactor technology. The Company’s therapeutic focus is on investigative collaborations to research and develop compounds to allow the safe and efficient non-invasive delivery of stem cells through the patient’s own circulatory system to a diseased or damaged organ.
Cryo-Cell (CCEL.OB) offers cellular processing and cryogenic storage, with a focus on the collection and preservation of umbilical cord blood stem cells as a family cord blood stem cell bank and preserves the specimens in commercially available cryogenic storage equipment.
Brainstorm Cell Therapeutics (BCLI.OB) is a development-stage company focused on focused on using a patient’s own bone marrow stem cells to generate neuron-like cells that provide treatment for Parkinson’s Disease (PD), Amyotrophic Lateral Sclerosis (ALS) and spinal cord injuries.
Opexa Therapeutics (OPXA) develops autologous (patient-derived) cell-based therapies to treat multiple sclerosis (MS), rheumatoid arthritis (RA), and diabetes based on the Company’s T-cell and adult stem cell technologies. Opexa's lead product candidate is Tovaxin (a T-cell based therapeutic vaccine) for MS which is in a Phase 2b clinical trial.
Neostem (NBS) operates a commercial, autologous (patient-derived) adult stem cell bank for the pre-disease collection, processing and long-term storage of stem cells from adult donors that they can access for their own future medical treatment. The Company manages a network of adult stem cell collection centers throughout the U.S. and conducts research to identify and isolate rare stem cells from bone marrow.
Bio-Matrix Scientific Group (BMSN.OB) is a provider of disposable instruments and medical devices which are used in stem cell extraction and tissue transfer procedures and also operates cryogenic stem cell banking facilities.
Cord Blood America (CBAI.OB) preserves umbilical cord blood stem cells through a quick and non-invasive procedure at the time of birth. CBAI is focused on marketing initiatives to increase awareness of their services, which literally represent a once in a lifetime opportunity to collect and preserve cord blood stem cells which can be used in the future to treat dozens of conditions with the promise of even more medical breakthroughs with the FDA ruling to allow human stem cell testing and pending federal funding for stem cell research.
The table at my website link below includes 26 companies in the ETF Innovators Emerging Stem Cell Index, which lost 7% of its market value in the past week (at 1,148 today) and posted a 15.2% loss over the past year on an equal-weight basis.
http://www.etfinnovators.com/2009/02/stem-cell-index-down-7-in-past-week.html
Results for benchmark indexes and ETFs include gains of 1.5% for the Cosmetic and Restorative Medicine Index and losses of 1.2% for SPDR S&P Biotech (XBI), 18.7% for Healthcare Sector SPDR (XLV), 7.2% for iShares Nasdaq Biotech (IBB), and 17.7% for PowerShares Biotech & Genome (PBE).
The next catalyst expected for stem cell and regenerative medicine companies is federal funding for stem cell research, which has been blocked by the previous administration for the past eight years. Look for an announcement soon to provide an upside catalyst for these companies now that the economic stimulus plan is expected to be finalized by Tuesday.
The decline in stem cell stocks over the past week was led by Geron (GERN), which declined by nearly 20% on Friday after the Company sold over 7M shares in a financing deal that will close on 2/19/09. Below is a summary and website links for the 26 companies included in the ETF Innovators Emerging Stem Cell Index, which are now featured at http://www.biomedreports.com/.
StemCells (STEM) engages in clinical and preclinical research and development for human neural stem cells and liver engrafting cells. Earlier stage preclinical work is focused on spinal cord injuries, myelin, and retinal disorders.
BioMimetic Therapeutics (BMTI) develops regenerative medicine device/therapeutic combination products for bio-therapeutic applications for orthopedic/spine, sports medicine, and dental procedures.
RTI Biologics (RTIX) is a provider of bio-implants and grafts to promote healing and repair for orthopedic/spinal applications, sports medicine, bone graft substitutes, and cardiovascular applications.
Cytori Therapeutics (CYTX) is a commercial-stage regenerative medicine company which is developing the Celution System to process a patient's own fat (adipose) tissue in about one hour for a variety of reconstructive and cosmetic medicine therapeutic applications.
CYTX also offers StemSource Cell Banking for a patient to preserve their own adipose-derived stem + regenerative cells (ADRCs) for use in the future as ongoing clinical trials establish the safety and effectiveness for cardiovascular disease, breast reconstruction/augmentation, liver disease, kidney failure, orthopedic/spinal disc regeneration, and gastrointestinal disorders.
CYTX currently offers its products and services in Japan and Europe along with two key strategic partners – Olympus Corp. (OCPNY.PK) (a strategic investor + medical device partner for Celution System) and Green Hospital Supply (GHSPF.PK) (a strategic investor + partner for StemSource Cell Banking, initially targeting hospitals in Japan).
Aastrom Biosciences (ASTM) is developing autologous (derived from the patient) cell products for the repair and regeneration of human tissue. Aastrom's Tissue Repair Cell (TRC) technology utilizes a patient's own bone marrow as the source of progenitor and stem cells for use in cardiac and vascular tissue regeneration.
Mesoblast (MBLTY.PK) (Australia: MSB.AX) is an adult stem cell company focused on commercializing RepliCart for bone and cartilage repair and regeneration, with recent approval to conduct a Phase 2 clinical trial for knee osteoarthritis. Mesoblast also has a U.S. subsidiary focused on cardiovascular applications for its regenerative medicine technology.
BioTime (BTIM.OB) offers blood plasma expanders such as Hextend along with its Embryome Sciences subsidiary, which includes 11 new cell lines that will be marketed to universities and bio-pharma companies for use in research programs focused on developing new cell-based therapies for neurodegenerative disease, muscular dystrophy, heart disease, cancer, and arthritis, as well as other potential applications in the emerging field of regenerative medicine.
Osteotech (OSTE) provides OsteoBiologic solutions for regenerative medicine applications to repair and replace bone loss caused by trauma or disease, augment prosthetic implant procedures, facilitate spinal fusion, and replace/repair damaged ligaments and tendons.
Neuralstem (CUR) manufactures human neural stem cells for research grant and collaborative programs and outsources the manufacturing and storage of its stem cells for use in pre-clinical studies to Charles River Labs (CRL).
RegeneRx Biopharma (RGN) has developed three drug product candidates based on a peptide molecule (Thymosin beta 4), which demonstrates promise for a variety of tissue and organ repair applications. RGN-137 is a topical gel product for healing chronic dermal wounds. RGN-259 is an eye drop for ophthalmic injuries. RGN-352 is an injectable treatment for heart attacks.
ThermoGenesis (KOOL) is a commercial-stage provider of systems for the storage and processing of adult stem cells derived from cord blood and bone marrow. KOOL offers the AutoXpress Platform (AXP) (cord blood processing) as a family of automated devices which includes the MarrowXpress (bone marrow processing) and related disposables as a closed system to process and collect adult stem cells.
The CryoSeal FS System produces fibrin sealants from blood in about one hour for use in liver resection surgeries. KOOL also expects to enter the veterinary stem cell market under the Vantus brand and plans to launch Res-Q (a system for real-time processing of bone marrow and platelet rich plasma processing) during its fiscal 4Q09 as the Company hopes to achieve profitability during 2010.
Athersys (ATHX) collaborates with Angiotech Pharma (ANPI) to develop MultiStem for the treatment of damage caused by heart attacks, peripheral vascular disease, and strokes in addition to support for stem cell transplants.
Advanced Cell Technology (ACTC.PK) focuses on human embryonic and adult stem cell technology, with FDA approval to begin Phase 2 clinical trials for adult stem cell technologies, which are focused on cardiovascular disease and transplants.
International Stem Cell Corp (ISCO.OB) offers a unique technology technology, Parthenogenesis, which results in the creation of pluripotent (ability to differentiate into a variety of unique cell types) human stem cell lines from unfertilized human eggs. ISCO's technology has the potential to eliminate the rejection of stem cell transplants, avoid ethical issues by eliminating the need for fertilized embryos, and produce specialized cells for research applications.
Bioheart (BHRT) recently secured private financing commitments for up to $7M and recently announced a grant-funded study in Italy for the Bioheart A&C Bio Science Twin-Pulsatile Life Support System which is expected to be completed within just 45 days with the potential for $2.1M in contract sales if results are positive.
BHRT develops devices and biological therapeutics for the diagnosis, treatment, and monitoring of cardiovascular disease and heart failure. MyoCell is the Company's lead product candidate, which represents a muscle-derived stem cell therapy designed to improve heart function by replacing scar tissue with living cells to restore function.
Pluristem Therapeutics (PSTI) has developed a pipeline of product candidates derived from the human placenta and processed by the Company's PluriX bio-reactor as allogeneic (ready-to-use, non-personalized cell therapy products). The Company's pipeline includes product candidates for the treatement of peripheral artery disease (PLX-PAD), inflammatory bowel disease (PLX-IBD), multiple sclerosis (PLX-MS), bone marrow transplants (PLX-BMT), and ischemic stroke (PLX-STROKE).
HepaLife Technologies (HPLF.OB) cell-based technologies under development include an artificial liver device (HepaMate), in-vitro toxicology and pre-clinical drug testing platforms, and cell-culture based vaccine production methods for the manufacture of vaccines against H5N1 avian influenza and other viruses.
Stem Cell Innovations (SCLL.PK) is a develop-stage company focused on its C3A human liver cell line for the production of human serum proteins, including the clotting factors, Factor VIII and Factor IX, used by hemophiliacs to allow their blood to clot.
Isolagen (ILE) develops products for skin and tissue rejuvenation which are designed to improve the appearance of skin injured by the effects of aging, sun exposure, acne, and burn scars using a patient’s own (autologous) fibroblast cells produced by its Isolagen Process for therapeutic and cosmetic medicine applications.
CellCyte Genetics (CCYG.OB) is a development-stage company focused on cell expansion and cell maintenance through the use of its patented bioreactor technology. The Company’s therapeutic focus is on investigative collaborations to research and develop compounds to allow the safe and efficient non-invasive delivery of stem cells through the patient’s own circulatory system to a diseased or damaged organ.
Cryo-Cell (CCEL.OB) offers cellular processing and cryogenic storage, with a focus on the collection and preservation of umbilical cord blood stem cells as a family cord blood stem cell bank and preserves the specimens in commercially available cryogenic storage equipment.
Brainstorm Cell Therapeutics (BCLI.OB) is a development-stage company focused on focused on using a patient’s own bone marrow stem cells to generate neuron-like cells that provide treatment for Parkinson’s Disease (PD), Amyotrophic Lateral Sclerosis (ALS) and spinal cord injuries.
Opexa Therapeutics (OPXA) develops autologous (patient-derived) cell-based therapies to treat multiple sclerosis (MS), rheumatoid arthritis (RA), and diabetes based on the Company’s T-cell and adult stem cell technologies. Opexa's lead product candidate is Tovaxin (a T-cell based therapeutic vaccine) for MS which is in a Phase 2b clinical trial.
Neostem (NBS) operates a commercial, autologous (patient-derived) adult stem cell bank for the pre-disease collection, processing and long-term storage of stem cells from adult donors that they can access for their own future medical treatment. The Company manages a network of adult stem cell collection centers throughout the U.S. and conducts research to identify and isolate rare stem cells from bone marrow.
Bio-Matrix Scientific Group (BMSN.OB) is a provider of disposable instruments and medical devices which are used in stem cell extraction and tissue transfer procedures and also operates cryogenic stem cell banking facilities.
Cord Blood America (CBAI.OB) preserves umbilical cord blood stem cells through a quick and non-invasive procedure at the time of birth. CBAI is focused on marketing initiatives to increase awareness of their services, which literally represent a once in a lifetime opportunity to collect and preserve cord blood stem cells which can be used in the future to treat dozens of conditions with the promise of even more medical breakthroughs with the FDA ruling to allow human stem cell testing and pending federal funding for stem cell research.
Tuesday, February 10, 2009
New Website Coming Soon!
New Website Coming Soon!
By Mike Havrilla on 2/10/09
ETF Innovators
A new website for healthcare investors and traders should be ready to launch by the end of February, which is designed to provide users with more features beyond my current blog format.
The site will feature its own blog, discussion forum, news feeds, videos, stock commentaries (including multiple contributors), and other unique content – including my FDA and Clinical Trial Calendars plus a database that includes hundreds of foreign and U.S.-listed stocks in the healthcare sector which are organized into unique indexes, including:
1.) Emerging Stem Cell Research – StemCells (STEM)
2.) Pet Care and Animal Farma – PetMed Express (PETS)
3.) Emerging and Micro-Cap Bio-Pharma (micro/small-cap biotechs and pharmaceuticals) – Dendreon (DNDN)
4.) Emerging Diagnostics – EXACT Sciences (EXAS)
5.) Cosmetic and Restorative Medicine (Regenerative Medicine, Skin Care + Cosmetic Medicine, Ortho Repair + Implants, and Cardiovascular Repair + Implants) – Genzyme (GENZ)
6.) Health Information Technology (IT) – Allscripts-Misys (MDRX)
7.) Generic Drugs (including biogenerics) – Teva Pharma (TEVA)
8.) Health Benefits and Hospitals – Aetna (AET)
9.) Preventive Medicine (Diagnostics, Vaccines, Diabetes Care) – Novo Nordisk (NVO)
The new indexes will be tracked and written about at the website to provide users with the ability to create their own healthcare ETFs for investment strategies beyond current broad-based funds and indexes such as Healthcare Sector SPDR (XLV), iShares S&P Global Healthcare (IXJ), iShares Nasdaq Biotech (IBB), SPDR S&P Biotech (XBI), Pharmaceutical HOLDDRs (PPH), Biotech HOLDRs (BBH), PowerShares Dynamic Pharma (PJP), and iShares Dow Jones U.S. Healthcare Provider (IHF).
Please note that my current site at www.ETFinnovators.com and RSS Feed at http://feedproxy.google.com/etfi will continue to be available for a limited time during the transition, but all new content will be posted at the new site in a variety of formats beyond just blog entries.
Please contact me if you are interested in purchasing the ETFinnovators.com website domain name (or the entire group of 15 business and investing domain names), with links to the Google Page Rank statistics and value estimates provided below.
http://www.google.com/Top/Business/Investing/Funds/ETFs_and_CEFs/
http://www.websiteoutlook.com/www.etfinnovators.com
Below are 14 additional business and investing website domain names available for sale either individually or in some other combination:
AIRETF.com
CoalPriceFund.com
DefensivETF.com
HealthETFS.com
HealthITFund.com
NordicETF.com
PerformIdex.com
RailroadETF.com
StemCellsETF.com
StemCellShares.com
StemCellsIndex.com
TobaccoETF.com
TransportETFS.com
TruckingETF.com
By Mike Havrilla on 2/10/09
ETF Innovators
A new website for healthcare investors and traders should be ready to launch by the end of February, which is designed to provide users with more features beyond my current blog format.
The site will feature its own blog, discussion forum, news feeds, videos, stock commentaries (including multiple contributors), and other unique content – including my FDA and Clinical Trial Calendars plus a database that includes hundreds of foreign and U.S.-listed stocks in the healthcare sector which are organized into unique indexes, including:
1.) Emerging Stem Cell Research – StemCells (STEM)
2.) Pet Care and Animal Farma – PetMed Express (PETS)
3.) Emerging and Micro-Cap Bio-Pharma (micro/small-cap biotechs and pharmaceuticals) – Dendreon (DNDN)
4.) Emerging Diagnostics – EXACT Sciences (EXAS)
5.) Cosmetic and Restorative Medicine (Regenerative Medicine, Skin Care + Cosmetic Medicine, Ortho Repair + Implants, and Cardiovascular Repair + Implants) – Genzyme (GENZ)
6.) Health Information Technology (IT) – Allscripts-Misys (MDRX)
7.) Generic Drugs (including biogenerics) – Teva Pharma (TEVA)
8.) Health Benefits and Hospitals – Aetna (AET)
9.) Preventive Medicine (Diagnostics, Vaccines, Diabetes Care) – Novo Nordisk (NVO)
The new indexes will be tracked and written about at the website to provide users with the ability to create their own healthcare ETFs for investment strategies beyond current broad-based funds and indexes such as Healthcare Sector SPDR (XLV), iShares S&P Global Healthcare (IXJ), iShares Nasdaq Biotech (IBB), SPDR S&P Biotech (XBI), Pharmaceutical HOLDDRs (PPH), Biotech HOLDRs (BBH), PowerShares Dynamic Pharma (PJP), and iShares Dow Jones U.S. Healthcare Provider (IHF).
Please note that my current site at www.ETFinnovators.com and RSS Feed at http://feedproxy.google.com/etfi will continue to be available for a limited time during the transition, but all new content will be posted at the new site in a variety of formats beyond just blog entries.
Please contact me if you are interested in purchasing the ETFinnovators.com website domain name (or the entire group of 15 business and investing domain names), with links to the Google Page Rank statistics and value estimates provided below.
http://www.google.com/Top/Business/Investing/Funds/ETFs_and_CEFs/
http://www.websiteoutlook.com/www.etfinnovators.com
Below are 14 additional business and investing website domain names available for sale either individually or in some other combination:
AIRETF.com
CoalPriceFund.com
DefensivETF.com
HealthETFS.com
HealthITFund.com
NordicETF.com
PerformIdex.com
RailroadETF.com
StemCellsETF.com
StemCellShares.com
StemCellsIndex.com
TobaccoETF.com
TransportETFS.com
TruckingETF.com
Monday, February 9, 2009
FDA Decision Calendar: Pain Drug Delays Likely
FDA Decision Calendar: Pain Drug Delays Likely
By Mike Havrilla on 2/9/09
ETF Innovators
The tables at my website link below include an updated calendar of 86 expected FDA new product decisions and 89 pending clinical trial result estimates + pending FDA re-submissions or new submissions for regulatory approval. Click here for a link to my previous calendars.
http://www.etfinnovators.com/2009/02/fda-decision-calendar-pain-drug-delays.html
New FDA Decision Calendar Entries:
1.) Biogen Idec (BIIB) and Genentech (DNA) have a PDUFA decision date of 7/15/09 for a pending sBLA to expand the use of Rituxan (rituximab) to include the treatment of moderate to severe rheumatoid arthritis in patients who have an inadequate response to one/more first-line treatments known as disease-modifying anti-rheumatic drugs (DMARDs).
2.) Johnson & Johnson (JNJ): JNJ has a PDUFA date of 8/4/09 for its complete response to an August 2008 approvable ruling for Paliperidone (Invega) Once-Monthly Injection for the treatment of schizophrenia. JNJ also filed a pair of sNDA's to expand the use of Invega E.R. Tablets to include the treatment schizoaffective disorder as both monotherapy and in combination with other treatments for the condition.
A Painful Ruling by the FDA:
The FDA issued a statement today directed at drug makers which market the strongest types of painkillers – classified as opiates, narcotics, and DEA Class 2 Controlled Substances. The FDA wants pain drug makers to play a larger role in stemming abuse and diversion issues amidst concern about the rising incidence of overdose deaths, abuse, misuse, and diversion associated with opiates such as Duragesic (fentanyl patches), OxyContin, and similar drugs.
King Pharma (KG) is most affected by the FDA's statement today since it is developing Remoxy and Embeda as two opiate painkillers designed to reduce the risk of abuse and misuse. Pain Therapeutics (PTIE) and KG received a complete response for Remoxy in December while KG acquired Embeda with the Alpharma acquisition, but the FDA has not issued a decision on the latter pending NDA.
BioDelivery Sciences (BDSI) also submitted a complete response for an opiate painkiller on 12/15/08, but Onsolis is targeted for hospital use in the treatment of breakthrough pain in cancer patients so it should not be affected by the ruling today. While King's two pending applications are abuse-resistant forms of opiates; they will be marketed to a much wider population compared to Onsolis and will likely face further delays given the FDA's statement today.
By Mike Havrilla on 2/9/09
ETF Innovators
The tables at my website link below include an updated calendar of 86 expected FDA new product decisions and 89 pending clinical trial result estimates + pending FDA re-submissions or new submissions for regulatory approval. Click here for a link to my previous calendars.
http://www.etfinnovators.com/2009/02/fda-decision-calendar-pain-drug-delays.html
New FDA Decision Calendar Entries:
1.) Biogen Idec (BIIB) and Genentech (DNA) have a PDUFA decision date of 7/15/09 for a pending sBLA to expand the use of Rituxan (rituximab) to include the treatment of moderate to severe rheumatoid arthritis in patients who have an inadequate response to one/more first-line treatments known as disease-modifying anti-rheumatic drugs (DMARDs).
2.) Johnson & Johnson (JNJ): JNJ has a PDUFA date of 8/4/09 for its complete response to an August 2008 approvable ruling for Paliperidone (Invega) Once-Monthly Injection for the treatment of schizophrenia. JNJ also filed a pair of sNDA's to expand the use of Invega E.R. Tablets to include the treatment schizoaffective disorder as both monotherapy and in combination with other treatments for the condition.
A Painful Ruling by the FDA:
The FDA issued a statement today directed at drug makers which market the strongest types of painkillers – classified as opiates, narcotics, and DEA Class 2 Controlled Substances. The FDA wants pain drug makers to play a larger role in stemming abuse and diversion issues amidst concern about the rising incidence of overdose deaths, abuse, misuse, and diversion associated with opiates such as Duragesic (fentanyl patches), OxyContin, and similar drugs.
King Pharma (KG) is most affected by the FDA's statement today since it is developing Remoxy and Embeda as two opiate painkillers designed to reduce the risk of abuse and misuse. Pain Therapeutics (PTIE) and KG received a complete response for Remoxy in December while KG acquired Embeda with the Alpharma acquisition, but the FDA has not issued a decision on the latter pending NDA.
BioDelivery Sciences (BDSI) also submitted a complete response for an opiate painkiller on 12/15/08, but Onsolis is targeted for hospital use in the treatment of breakthrough pain in cancer patients so it should not be affected by the ruling today. While King's two pending applications are abuse-resistant forms of opiates; they will be marketed to a much wider population compared to Onsolis and will likely face further delays given the FDA's statement today.
Stem Cell Index Down 1% in Past Week
Stem Cell Index Down 1% in Past Week
By Mike Havrilla on 2/9/09
ETF Innovators, LLP
The table at my website link below includes 29 companies in the ETF Innovators (ETFI) Emerging Stem Cell Index, which lost about 1% of market value in the past week and posted an 8.5% loss over the past year on an equal-weight basis. Results for benchmark indexes and ETFs include gains of 1.5% for SPDR S&P Biotech (XBI) and 1.2% for the ETFI Cosmetic and Reconstructive Medicine Index and losses of 17.4% for Healthcare Sector SPDR (XLV), 3.7% for iShares Nasdaq Biotech (IBB), and 14.5% for PowerShares Biotech & Genome (PBE).
http://www.etfinnovators.com/2009/02/stem-cell-index-down-1-in-past-week.html
The next catalyst expected for stem cell and regenerative medicine companies is federal funding for stem cell research, which has been blocked by the previous administration for the past eight years. Look for an announcement and upside catalyst once the stimulus and bank rescue plans are finalized.
Today's feature stock from the index is Cord Blood America (OTC: CBAI), which preserves umbilical cord blood stem cells through a quick and non-invasive procedure at the time of birth. CBAI is focused on marketing initiatives to increase awareness of their services, which literally represent a once in a lifetime opportunity to collect and preserve cord blood stem cells which can be used in the future to treat dozens of conditions with the promise of even more medical breakthroughs with the FDA ruling to allow human stem cell testing and pending federal funding for stem cell research.
Other companies in the index which I have written about recently include Cytori Therapeutics (CYTX), ThermoGenesis (KOOL), and Bioheart (BHRT). Larger companies from the ETFI Cosmetic and Restorative Index I have covered include Osiris Therapeutics (OSIR), Geron (GERN), and Genzyme (GENZ).
Stay tuned for more details and web links for a new website for healthcare investors and traders, which is designed to provide users with more features beyond my current blog format. The new site will feature a discussion forum, news feeds, videos, stock commentaries (including multiple contributors), and other unique content – including my FDA and Clinical Trial Calendars.
Below are 14 business and investing website domain names available for sale and development, including three related to stem cells:
www.AIRETF.com
www.CoalPriceFund.com
www.DefensivETF.com
www.HealthETFS.com
www.HealthITFund.com
www.NordicETF.com
www.PerformIdex.com
www.RailroadETF.com
www.StemCellsETF.com
www.StemCellShares.com
www.StemCellsIndex.com
www.TobaccoETF.com
www.TransportETFS.com
www.TruckingETF.com
By Mike Havrilla on 2/9/09
ETF Innovators, LLP
The table at my website link below includes 29 companies in the ETF Innovators (ETFI) Emerging Stem Cell Index, which lost about 1% of market value in the past week and posted an 8.5% loss over the past year on an equal-weight basis. Results for benchmark indexes and ETFs include gains of 1.5% for SPDR S&P Biotech (XBI) and 1.2% for the ETFI Cosmetic and Reconstructive Medicine Index and losses of 17.4% for Healthcare Sector SPDR (XLV), 3.7% for iShares Nasdaq Biotech (IBB), and 14.5% for PowerShares Biotech & Genome (PBE).
http://www.etfinnovators.com/2009/02/stem-cell-index-down-1-in-past-week.html
The next catalyst expected for stem cell and regenerative medicine companies is federal funding for stem cell research, which has been blocked by the previous administration for the past eight years. Look for an announcement and upside catalyst once the stimulus and bank rescue plans are finalized.
Today's feature stock from the index is Cord Blood America (OTC: CBAI), which preserves umbilical cord blood stem cells through a quick and non-invasive procedure at the time of birth. CBAI is focused on marketing initiatives to increase awareness of their services, which literally represent a once in a lifetime opportunity to collect and preserve cord blood stem cells which can be used in the future to treat dozens of conditions with the promise of even more medical breakthroughs with the FDA ruling to allow human stem cell testing and pending federal funding for stem cell research.
Other companies in the index which I have written about recently include Cytori Therapeutics (CYTX), ThermoGenesis (KOOL), and Bioheart (BHRT). Larger companies from the ETFI Cosmetic and Restorative Index I have covered include Osiris Therapeutics (OSIR), Geron (GERN), and Genzyme (GENZ).
Stay tuned for more details and web links for a new website for healthcare investors and traders, which is designed to provide users with more features beyond my current blog format. The new site will feature a discussion forum, news feeds, videos, stock commentaries (including multiple contributors), and other unique content – including my FDA and Clinical Trial Calendars.
Below are 14 business and investing website domain names available for sale and development, including three related to stem cells:
www.AIRETF.com
www.CoalPriceFund.com
www.DefensivETF.com
www.HealthETFS.com
www.HealthITFund.com
www.NordicETF.com
www.PerformIdex.com
www.RailroadETF.com
www.StemCellsETF.com
www.StemCellShares.com
www.StemCellsIndex.com
www.TobaccoETF.com
www.TransportETFS.com
www.TruckingETF.com
Saturday, February 7, 2009
New Index for Pet Care and Animal 'Farma'
This past week, CNBC's Trish Regan took an in-depth look at the pet industry and Westminster Dog Show (which runs Feb. 7-16), which attracts millions of viewers and thousands of dogs and pet owners vying to earn the Best in Show designation. Late last year, Ladenburg Thalmann analyst Nancy Hull appeared on CNBC talking about PetMed Express (PETS) and the recession-resistant nature of the pet med business.
PETS turned out to be a good call – the stock is up about 20% in the past year, making it the second best gainer in the entire index. Other U.S. listed stocks in the index which posted gains over the past year include Neogen (NEOG) (animal diagnostics), Balchem (BCPC) (animal nutrition + health), and Central Garden & Pet (pet retailer).
The table at my website link below provides statistics for the 30 companies included in the ETF Innovators Global Pet Care and Animal 'Farma' Index. The index posted a loss of 20.4% in the past year on an equal weight basis, compared to losses of 35.1% for S&P 500 SPDR (SPY), 41.4% for Market Vectors Agribusiness (MOO), 17.7% for Healthcare Sector SPDR (XLV), and 19% for iShares S&P Global Healthcare (IXJ) over the past year.
http://www.etfinnovators.com/2009/02/new-index-for-pet-care-and-animal-farma.html
The index tracks companies which are active in the following business segments: animal breeding, veterinary services, pet retailers, animal feeds/nutrition, and veterinary medicine/diagnostics. The index includes companies with market caps of $100M-$10B, which makes them more leveraged to the pet and animal care industry and also makes them ideal takeover candidates for larger players in animal health such as Pfizer (PFE), Schering-Plough (SGP) (Intervet), Novartis (NVS), Merck (MRK) + Sanofi-Aventis (SNY) joint venture (Merial), Wyeth (WYE) (Fort Dodge), and Eli Lilly (LLY) (Elanco).
In addition, favorable growth trends for the pet and animal care industry include the following:
1.) Pet spending in the U.S. is estimated at $43.4B in 2008, up from $32.4B in 2003
2.) About 63% of U.S. households have a pet, which equals over 71M homes
3.) The worldwide market for animal healthcare, excluding bulk feed and nutrition products, is expected to reach just under $20B in 2008, experiencing growth of 26% from $15.6B in 2003.
PETS turned out to be a good call – the stock is up about 20% in the past year, making it the second best gainer in the entire index. Other U.S. listed stocks in the index which posted gains over the past year include Neogen (NEOG) (animal diagnostics), Balchem (BCPC) (animal nutrition + health), and Central Garden & Pet (pet retailer).
The table at my website link below provides statistics for the 30 companies included in the ETF Innovators Global Pet Care and Animal 'Farma' Index. The index posted a loss of 20.4% in the past year on an equal weight basis, compared to losses of 35.1% for S&P 500 SPDR (SPY), 41.4% for Market Vectors Agribusiness (MOO), 17.7% for Healthcare Sector SPDR (XLV), and 19% for iShares S&P Global Healthcare (IXJ) over the past year.
http://www.etfinnovators.com/2009/02/new-index-for-pet-care-and-animal-farma.html
The index tracks companies which are active in the following business segments: animal breeding, veterinary services, pet retailers, animal feeds/nutrition, and veterinary medicine/diagnostics. The index includes companies with market caps of $100M-$10B, which makes them more leveraged to the pet and animal care industry and also makes them ideal takeover candidates for larger players in animal health such as Pfizer (PFE), Schering-Plough (SGP) (Intervet), Novartis (NVS), Merck (MRK) + Sanofi-Aventis (SNY) joint venture (Merial), Wyeth (WYE) (Fort Dodge), and Eli Lilly (LLY) (Elanco).
In addition, favorable growth trends for the pet and animal care industry include the following:
1.) Pet spending in the U.S. is estimated at $43.4B in 2008, up from $32.4B in 2003
2.) About 63% of U.S. households have a pet, which equals over 71M homes
3.) The worldwide market for animal healthcare, excluding bulk feed and nutrition products, is expected to reach just under $20B in 2008, experiencing growth of 26% from $15.6B in 2003.
Friday, February 6, 2009
Healthcare Investing Trends for '09 and Beyond
Healthcare Investing Trends for '09 and Beyond
By Mike Havrilla on 2/6/09
ETF Innovators
http://www.etfinnovators.com/2009/02/healthcare-investing-trends-for-09-and.html
While the departure of Tom Daschle and concerns over rising unemployment and the global economic slowdown may hamper many of President Obama's plans for healthcare reform; there are several growth trends within the sector outlined below which are poised to benefit in 2009 and beyond. Follow any of the links below for more information on the new ETF Innovators indexes and exchange-traded fund ideas for the sector.
Global Health IT: The top five rated companies include Swiss telemedicine firm Card Guard (CDGUF) – a provider of remote patient monitoring systems, Merge Healthcare (MRGE) – a clinical + medical imaging information software developer, Quality Systems (QSII) – NextGen electronic medical records system, SXC Health Solutions (SXCI) – pharmacy benefit management + transaction systems, and CardiNet (BEAT) – CardioNet System for real-time, outpatient heart rhythm monitoring.
Cerner (CERN) and Allscripts-Misys (MDRX) are two more companies included in the top 30 rated stocks as integrated Health IT plays on electronic prescribing (e-prescribing), computerized medical records, and health information systems. The entire Health IT space is poised to benefit (although not immediately) from an expected multi-billion dollar investment (likely around $20B) as part of an overall $800B-plus stimulus plan which is still being debated.
Generic Drugs: The Healthcare Cost Containment Index includes generic drug companies such as Teva Pharma (TEVA) and Perrigo (PRGO) as well as pharmacy benefit managers such as Express Scripts (ESRX), which share the common theme of promoting the use of generic drug products to lower overall healthcare costs.
Favorable growth trends for the generic drug industry include nearly $70B in brand name drug sales with patent expirations through 2012, a push to increase generic substitution rates from 65% of all prescriptions dispensed to over 70%, continued industry consolidation of small and mid-caps by industry leaders such as TEVA and Mylan Labs (MYL), and the potential for legislation this year regarding generic versions of high-cost biological agents, with Merck (MRK) announcing plans for a bio-generic division which will initially target Amgen's (AMGN) anemia drug Aranesp.
Preventive Medicine: An index of companies involved in diagnostics, lab services, diabetes care, and vaccines which have positive growth trends and represent M&A targets for big pharma companies, such as Pfizer's (PFE) recent deal for Wyeth (WYE) in which PFE cited Wyeth's high-growth vaccine + biological agent business as a major reason for the deal. Crucell (CRXL) represents the largest pure-play vaccine maker with a market cap over $1B, and the stock is up nearly 20% since I wrote about it last week as a likely takeover target this year.
Cosmetic and Restorative Medicine (CRM): The CRM Index is organized to include companies which either enhance appearance or restore bodily functions (with increased demand expected from an aging Baby Boomer population and as medical advances allow people to live longer) – including a breakdown of approximately 15% stem cells + regenerative medicine, 25% skin care + cosmetic medicine, 30% orthopedic repair + implants, and 30% cardiovascular repair + implants.
While the Emerging Stem Cell Index would not be feasible for a standalone ETF, it serves as a feeder index for companies which progress above the $100M market cap level to be eligible for the CRM index such as StemCells (STEM), Cytori Therapeutics (CYTX), RTI Biologics (RTIX), and BioMimetic Therapeutics (BMTI).
Favorable trends for stem cell companies include the allowance by the FDA for human embryonic stem cell testing, the move by big pharma into regenerative medicine as the next frontier for R&D, the likelihood of federal funding for stem cell research, and expected 2Q09 results for Osiris Therapeutics (OSIR) leading to a rolling BLA submission for Prochymal as part of a major deal with Genzyme (GENZ).
By Mike Havrilla on 2/6/09
ETF Innovators
http://www.etfinnovators.com/2009/02/healthcare-investing-trends-for-09-and.html
While the departure of Tom Daschle and concerns over rising unemployment and the global economic slowdown may hamper many of President Obama's plans for healthcare reform; there are several growth trends within the sector outlined below which are poised to benefit in 2009 and beyond. Follow any of the links below for more information on the new ETF Innovators indexes and exchange-traded fund ideas for the sector.
Global Health IT: The top five rated companies include Swiss telemedicine firm Card Guard (CDGUF) – a provider of remote patient monitoring systems, Merge Healthcare (MRGE) – a clinical + medical imaging information software developer, Quality Systems (QSII) – NextGen electronic medical records system, SXC Health Solutions (SXCI) – pharmacy benefit management + transaction systems, and CardiNet (BEAT) – CardioNet System for real-time, outpatient heart rhythm monitoring.
Cerner (CERN) and Allscripts-Misys (MDRX) are two more companies included in the top 30 rated stocks as integrated Health IT plays on electronic prescribing (e-prescribing), computerized medical records, and health information systems. The entire Health IT space is poised to benefit (although not immediately) from an expected multi-billion dollar investment (likely around $20B) as part of an overall $800B-plus stimulus plan which is still being debated.
Generic Drugs: The Healthcare Cost Containment Index includes generic drug companies such as Teva Pharma (TEVA) and Perrigo (PRGO) as well as pharmacy benefit managers such as Express Scripts (ESRX), which share the common theme of promoting the use of generic drug products to lower overall healthcare costs.
Favorable growth trends for the generic drug industry include nearly $70B in brand name drug sales with patent expirations through 2012, a push to increase generic substitution rates from 65% of all prescriptions dispensed to over 70%, continued industry consolidation of small and mid-caps by industry leaders such as TEVA and Mylan Labs (MYL), and the potential for legislation this year regarding generic versions of high-cost biological agents, with Merck (MRK) announcing plans for a bio-generic division which will initially target Amgen's (AMGN) anemia drug Aranesp.
Preventive Medicine: An index of companies involved in diagnostics, lab services, diabetes care, and vaccines which have positive growth trends and represent M&A targets for big pharma companies, such as Pfizer's (PFE) recent deal for Wyeth (WYE) in which PFE cited Wyeth's high-growth vaccine + biological agent business as a major reason for the deal. Crucell (CRXL) represents the largest pure-play vaccine maker with a market cap over $1B, and the stock is up nearly 20% since I wrote about it last week as a likely takeover target this year.
Cosmetic and Restorative Medicine (CRM): The CRM Index is organized to include companies which either enhance appearance or restore bodily functions (with increased demand expected from an aging Baby Boomer population and as medical advances allow people to live longer) – including a breakdown of approximately 15% stem cells + regenerative medicine, 25% skin care + cosmetic medicine, 30% orthopedic repair + implants, and 30% cardiovascular repair + implants.
While the Emerging Stem Cell Index would not be feasible for a standalone ETF, it serves as a feeder index for companies which progress above the $100M market cap level to be eligible for the CRM index such as StemCells (STEM), Cytori Therapeutics (CYTX), RTI Biologics (RTIX), and BioMimetic Therapeutics (BMTI).
Favorable trends for stem cell companies include the allowance by the FDA for human embryonic stem cell testing, the move by big pharma into regenerative medicine as the next frontier for R&D, the likelihood of federal funding for stem cell research, and expected 2Q09 results for Osiris Therapeutics (OSIR) leading to a rolling BLA submission for Prochymal as part of a major deal with Genzyme (GENZ).
New Website Coming Soon!
Stay tuned for more details and web links for a new website for healthcare investors and traders, which is designed to provide users with more features beyond my current blog format.
The new site will feature its own blog, discussion forum, news feeds, videos, stock commentaries (including multiple contributors), and other unique content – including my FDA and Clinical Trial Calendars plus a database that includes hundreds of U.S.-listed stocks in the healthcare sector which are organized into unique indexes such as the Emerging Stem Cell Index, Pet Care & Animal Farma, Micro-Cap Bio-Pharma, Diagnostics, and others which will be tracked at the website.
Please note that my current site at www.ETFinnovators.com and RSS Feed at http://feedproxy.google.com/etfi will continue to be available for a limited time after the new site launch, but will be gradually phased out.
Please contact me if you are interested in purchasing the ETFinnovators.com website domain name (or the entire group of 15 business and investing domain names), with links to the Google Page Rank statistics and value estimates provided below.
http://www.google.com/Top/Business/Investing/Funds/ETFs_and_CEFs/
http://www.websiteoutlook.com/www.etfinnovators.com
Below are 14 additional business and investing website domain names available for sale:
AIRETF.com
CoalPriceFund.com
DefensivETF.com
HealthETFS.com
HealthITFund.com
NordicETF.com
PerformIdex.com
RailroadETF.com
StemCellsETF.com
StemCellShares.com
StemCellsIndex.com
TobaccoETF.com
TransportETFS.com
TruckingETF.com
The new site will feature its own blog, discussion forum, news feeds, videos, stock commentaries (including multiple contributors), and other unique content – including my FDA and Clinical Trial Calendars plus a database that includes hundreds of U.S.-listed stocks in the healthcare sector which are organized into unique indexes such as the Emerging Stem Cell Index, Pet Care & Animal Farma, Micro-Cap Bio-Pharma, Diagnostics, and others which will be tracked at the website.
Please note that my current site at www.ETFinnovators.com and RSS Feed at http://feedproxy.google.com/etfi will continue to be available for a limited time after the new site launch, but will be gradually phased out.
Please contact me if you are interested in purchasing the ETFinnovators.com website domain name (or the entire group of 15 business and investing domain names), with links to the Google Page Rank statistics and value estimates provided below.
http://www.google.com/Top/Business/Investing/Funds/ETFs_and_CEFs/
http://www.websiteoutlook.com/www.etfinnovators.com
Below are 14 additional business and investing website domain names available for sale:
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Thursday, February 5, 2009
FDA Calendar: New Entries, One-Week Outlook
FDA Calendar: New Entries, One-Week Outlook
By Mike Havrilla on 2/5/09
ETF Innovators
The table at my website link below includes 84 pending FDA new product decision dates. Click here for a link to my previous calendars and here for 16 extreme FDA trades of companies with market caps below $150M with pending decisions.
http://www.etfinnovators.com/2009/02/fda-calendar-new-entries-one-week.html
New Entries on the FDA Calendar:
1.) Acorda Therapeutics (ACOR): ACOR filed a NDA for Fampridine-SR Oral Tablet to improve the walking ability of people with multiple sclerosis (MS) with a standard review expected and a PDUFA date of 11/30/09. ACOR also plans to file for marketing approval in the E.U. with the European Medicines Agency after it determines its strategy for commercialization in that region.
2.) Boston Scientific (BSX) + Angiotech Pharma (ANPI): BSX filed a PMA on 2/5/09 for two TAXUS (Liberte Atom & Long) drug-eluting coronary stents (DES) with a decision possible by year-end, although PMAs do not have decision deadlines.
3.) BioForm Medical (BFRM): BFRM filed a PMA for its Radiesse Dermal Filler (which is already on the market) combined with lidocaine (as a numbing agent for the skin) with a decision possible by year-end. The Company also plans to file for FDA approval during 1H09 for polidocanol as a treatment for varicose veins (sclerosing agent).
Review of FDA Advisory Panels this Week:
1.) Dyax Corp. (DYAX): DYAX secured a narrow approval (with a 6-5-2 vote) for its Kalbitor (ecallantide or DX-88) BLA with a PDUFA date of 3/23/09, which is designated for priority review in the treatment of acute attacks of hereditary angioedema (HAE is a rare disorder marked by severe swelling which can be fatal if the throat area is involved).
The panel debated the need for an effective treatment for this rare, potentially dangerous condition against the 3% higher incidence of allergic reactions (13% versus 10%) in patients taking the drug along with questions about the data generated in the clinical trials. ViroPharma (VPHM) has a PDUFA date of 10/1/09 for its Cinryze C1 Inhibitor sBLA to expand its label to include the treatment of HAE.
2.) Eli Lilly (LLY) and Daiichi Sankyo (DSKYY) received unanimous FDA panel recommendation (9-0) for approval of Effient (prasugrel) to compete with multi-billion dollar Plavix from Sanofi-Aventis (SNY) and Bristol-Myers (BMY) for the treatment of acute coronary syndrome. It appears likely Effient will receive FDA approval for a smaller patient population (i.e. excluding patients with a history of stroke) due to the increased risk of bleeding complications.
One-Week Outlook:
GTC Biotherapeutics (GTCB) – GTCB has a PDUFA date of 2/7/09 (which falls on Saturday, so a decision may not be issued until Monday if the FDA sticks to its deadline) for its Atryn (recombinant human anti-thrombin) BLA for deep vein thrombosis (DVTs or blood clots), which would represent the world's first therapeutic from genetically engineered animals (goats). An FDA advisory panel already voted that Atryn is safe + effective and the stock price has been rising steadily ever since.
Also, the FDA issued its final guidance in mid-January for the regulation and review of products made from genetically engineered animals -- setting the stage for approval of Atryn any day now (since there are no outstanding issues to prevent or delay FDA approval) and adding substantial value to GTC Bio's technology platform, which can be applied for large-scale, low-cost production of a variety of therapeutic proteins and other complex biological agents.
By Mike Havrilla on 2/5/09
ETF Innovators
The table at my website link below includes 84 pending FDA new product decision dates. Click here for a link to my previous calendars and here for 16 extreme FDA trades of companies with market caps below $150M with pending decisions.
http://www.etfinnovators.com/2009/02/fda-calendar-new-entries-one-week.html
New Entries on the FDA Calendar:
1.) Acorda Therapeutics (ACOR): ACOR filed a NDA for Fampridine-SR Oral Tablet to improve the walking ability of people with multiple sclerosis (MS) with a standard review expected and a PDUFA date of 11/30/09. ACOR also plans to file for marketing approval in the E.U. with the European Medicines Agency after it determines its strategy for commercialization in that region.
2.) Boston Scientific (BSX) + Angiotech Pharma (ANPI): BSX filed a PMA on 2/5/09 for two TAXUS (Liberte Atom & Long) drug-eluting coronary stents (DES) with a decision possible by year-end, although PMAs do not have decision deadlines.
3.) BioForm Medical (BFRM): BFRM filed a PMA for its Radiesse Dermal Filler (which is already on the market) combined with lidocaine (as a numbing agent for the skin) with a decision possible by year-end. The Company also plans to file for FDA approval during 1H09 for polidocanol as a treatment for varicose veins (sclerosing agent).
Review of FDA Advisory Panels this Week:
1.) Dyax Corp. (DYAX): DYAX secured a narrow approval (with a 6-5-2 vote) for its Kalbitor (ecallantide or DX-88) BLA with a PDUFA date of 3/23/09, which is designated for priority review in the treatment of acute attacks of hereditary angioedema (HAE is a rare disorder marked by severe swelling which can be fatal if the throat area is involved).
The panel debated the need for an effective treatment for this rare, potentially dangerous condition against the 3% higher incidence of allergic reactions (13% versus 10%) in patients taking the drug along with questions about the data generated in the clinical trials. ViroPharma (VPHM) has a PDUFA date of 10/1/09 for its Cinryze C1 Inhibitor sBLA to expand its label to include the treatment of HAE.
2.) Eli Lilly (LLY) and Daiichi Sankyo (DSKYY) received unanimous FDA panel recommendation (9-0) for approval of Effient (prasugrel) to compete with multi-billion dollar Plavix from Sanofi-Aventis (SNY) and Bristol-Myers (BMY) for the treatment of acute coronary syndrome. It appears likely Effient will receive FDA approval for a smaller patient population (i.e. excluding patients with a history of stroke) due to the increased risk of bleeding complications.
One-Week Outlook:
GTC Biotherapeutics (GTCB) – GTCB has a PDUFA date of 2/7/09 (which falls on Saturday, so a decision may not be issued until Monday if the FDA sticks to its deadline) for its Atryn (recombinant human anti-thrombin) BLA for deep vein thrombosis (DVTs or blood clots), which would represent the world's first therapeutic from genetically engineered animals (goats). An FDA advisory panel already voted that Atryn is safe + effective and the stock price has been rising steadily ever since.
Also, the FDA issued its final guidance in mid-January for the regulation and review of products made from genetically engineered animals -- setting the stage for approval of Atryn any day now (since there are no outstanding issues to prevent or delay FDA approval) and adding substantial value to GTC Bio's technology platform, which can be applied for large-scale, low-cost production of a variety of therapeutic proteins and other complex biological agents.
Wednesday, February 4, 2009
FDA Decision Calendar: 16 Extreme Trades
FDA Decision Calendar: 16 Extreme Trades
By Mike Havrilla on 2/4/09
ETF Innovators
Click here for a link to my previous FDA calendars and the list below highlights 16 companies with pending new product decisions at the agency + market caps below $150M, making them ideal candidates for extreme stock price volatility trades.
http://www.etfinnovators.com/2009/02/fda-decision-calendar-16-extreme-trades.html
BioDelivery Sciences (BDSI) – Onsolis approval is possible by mid-2009 and the Company raised $6M in cash from partner Meda AB, representing a $3M expanded licensing agreement + a $3M advance of the $30M milestone payment upon FDA approval. The remaining $27M cash milestone payment on FDA approval for Onsolis represents nearly one-half of the Company's current market cap, in addition to royalties that will be received on product sales once the breakthrough cancer pain drug is on the market.
Discovery Labs (DSCO) has a 4/17/09 PDUFA decision date for Surfaxin (lucinactant) for the prevention of respiratory distress syndrome (RDS) in premature infants. DSCO received its third approvable letter for Surfaxin last May and submitted its complete response to the FDA in mid-October. The stock price dipped below a dollar after the FDA issued a six-month Class II review (as investors hoped for the shorter 60-day Class I review) for the NDA re-submission, but DSCO has rebounded to the mid-dollar range as the decision date nears and insiders have purchased over 338,000 shares of stock in the past six months.
GTC Biotherapeutics (GTCB) – A decision is expected by 2/7/09 for the Atryn (recombinant human antithrombin) BLA for deep vein thrombosis (DVTs or blood clots), which would represent the world's first therapeutic from genetically engineered animals (goats). An FDA advisory panel already voted that Atryn is safe + effective and the stock price has been rising ever since.
Hemispherx Biopharma (HEB) – A decision is expected by 2/25/08 for the Company's resubmission of its Ampligen NDA, which is designated as an Orphan Drug for the treatment of chronic fatigue syndrome, which has no FDA approved treatments on the market. Ampligen is also authorized for Emergency (compassionate) Cost Recovery Sales Authorization by the FDA and has a "promising" designation by the Agency on Health Research Quality, "Ampligen, an investigational drug that is not approved by the FDA, given intravenously to severely debilitated patients, yielded the most promising results."
Northfield Labs (NFLD) – The FDA accepted the Company's BLA for PolyHeme and granted a priority review in the treatment of life-threatening red blood cell loss with a PDUFA date of 4/30/09. Around the same time late last year, Biopure (BPUR) received a clinical hold notice from the FDA, which blocks future clinical trials of its blood substitute candidate Hemopure. Since the FDA cited general concerns over deaths in clinical trials of blood substitutes, NFLD remains as the only game in town in the quest for a blood substitute since its BLA was accepted with a priority review.
Somaxon Pharma (SOMX) – The Company's Silenor (doxepin) NDA for the treatment of insomnia was filed under the 505(b)(2) pathway since doxepin is an approved drug, which is already available on the market in generic formulations. Somaxon's new formulation of doxepin is at lower doses (1, 3, 6 mg) compared to existing generic products on the market at doses of 10mg-150mg, which result in a higher incidence of side effects.
Vanda Pharma (VNDA) has a PDUFA date of 5/6/09 for its iloperidone NDA as a resubmission to a not approvable ruling on 7/25/08 for the atypical anti-psychotic in the treatment of schizophrenia.
ARCA Biopharma (ABIO) has a PDUFA date of 5/31/09 for the Gencaro (bucindolol) NDA in the treatment of chronic heart failure. Gencaro (bucindolol) for the treatment of chronic heart failure. ARCA also has a collaboration with LabCorp (LH) and a pending PMA for a genetic test which is designed to be used in conjunction with Gencaro. ARCA has identified genetic traits which the Company believes will predict patient responses to the drug and hopes to launch both as a personalized medicine combination to optimize treatment outcomes.
Novacea (NOVC) has a PDUFA date of 7/30/09 for its Intermezzo (zolpidem sublingual lozenge) NDA for as-needed use to treat insomnia from middle of night awakenings.
Advanced Life Sciences (ADLS) has a PDUFA date of 8/1/09 for its cethromycin NDA, which is a once-daily antibiotic for the treatment of community acquired pneumonia.
NeurogesX (NGSX) has a PDUFA date of 8/22/09 for its Qutenza (NGX-4010) capsaicin skin patch NDA for post-herpetic neuralgia (nerve pain that occurs after shingles outbreak).
ISTA Pharma (ISTA) has a PDUFA date of 9/12/09 for its Bepreve (bepotastine) eye drop NDA for ocular itching associated with allergic conjunctivitis.
Spectrum Pharma (SPPI) + Cell Therapeutics (CTIC) have a PDUFA date of 4/2/09 for their Zevalin sBLA (priority review) as consolidation therapy in the treatment of follicular B-cell non-Hodgkin's lymphoma (NHL) if the patient experiences a response to first-line treatment. CTIC also plans to begin a rolling NDA submission for pixantrone during 1Q09 for the treatment of relapsed, aggressive NHL.
Angiotech Pharma (ANPI) expects a decision by mid-2009 for its Bio-Seal Lung Biopsy Track Plug 510(k) application.
Labopharm (DDSS) has a PDUFA of 7/18/09 for its rapid-onset trazodone (DDS-04A) 505(b)(2) application for the treatment of major depressive disorder, which represents a new formulation of an existing drug that is also available in generic formulations.
By Mike Havrilla on 2/4/09
ETF Innovators
Click here for a link to my previous FDA calendars and the list below highlights 16 companies with pending new product decisions at the agency + market caps below $150M, making them ideal candidates for extreme stock price volatility trades.
http://www.etfinnovators.com/2009/02/fda-decision-calendar-16-extreme-trades.html
BioDelivery Sciences (BDSI) – Onsolis approval is possible by mid-2009 and the Company raised $6M in cash from partner Meda AB, representing a $3M expanded licensing agreement + a $3M advance of the $30M milestone payment upon FDA approval. The remaining $27M cash milestone payment on FDA approval for Onsolis represents nearly one-half of the Company's current market cap, in addition to royalties that will be received on product sales once the breakthrough cancer pain drug is on the market.
Discovery Labs (DSCO) has a 4/17/09 PDUFA decision date for Surfaxin (lucinactant) for the prevention of respiratory distress syndrome (RDS) in premature infants. DSCO received its third approvable letter for Surfaxin last May and submitted its complete response to the FDA in mid-October. The stock price dipped below a dollar after the FDA issued a six-month Class II review (as investors hoped for the shorter 60-day Class I review) for the NDA re-submission, but DSCO has rebounded to the mid-dollar range as the decision date nears and insiders have purchased over 338,000 shares of stock in the past six months.
GTC Biotherapeutics (GTCB) – A decision is expected by 2/7/09 for the Atryn (recombinant human antithrombin) BLA for deep vein thrombosis (DVTs or blood clots), which would represent the world's first therapeutic from genetically engineered animals (goats). An FDA advisory panel already voted that Atryn is safe + effective and the stock price has been rising ever since.
Hemispherx Biopharma (HEB) – A decision is expected by 2/25/08 for the Company's resubmission of its Ampligen NDA, which is designated as an Orphan Drug for the treatment of chronic fatigue syndrome, which has no FDA approved treatments on the market. Ampligen is also authorized for Emergency (compassionate) Cost Recovery Sales Authorization by the FDA and has a "promising" designation by the Agency on Health Research Quality, "Ampligen, an investigational drug that is not approved by the FDA, given intravenously to severely debilitated patients, yielded the most promising results."
Northfield Labs (NFLD) – The FDA accepted the Company's BLA for PolyHeme and granted a priority review in the treatment of life-threatening red blood cell loss with a PDUFA date of 4/30/09. Around the same time late last year, Biopure (BPUR) received a clinical hold notice from the FDA, which blocks future clinical trials of its blood substitute candidate Hemopure. Since the FDA cited general concerns over deaths in clinical trials of blood substitutes, NFLD remains as the only game in town in the quest for a blood substitute since its BLA was accepted with a priority review.
Somaxon Pharma (SOMX) – The Company's Silenor (doxepin) NDA for the treatment of insomnia was filed under the 505(b)(2) pathway since doxepin is an approved drug, which is already available on the market in generic formulations. Somaxon's new formulation of doxepin is at lower doses (1, 3, 6 mg) compared to existing generic products on the market at doses of 10mg-150mg, which result in a higher incidence of side effects.
Vanda Pharma (VNDA) has a PDUFA date of 5/6/09 for its iloperidone NDA as a resubmission to a not approvable ruling on 7/25/08 for the atypical anti-psychotic in the treatment of schizophrenia.
ARCA Biopharma (ABIO) has a PDUFA date of 5/31/09 for the Gencaro (bucindolol) NDA in the treatment of chronic heart failure. Gencaro (bucindolol) for the treatment of chronic heart failure. ARCA also has a collaboration with LabCorp (LH) and a pending PMA for a genetic test which is designed to be used in conjunction with Gencaro. ARCA has identified genetic traits which the Company believes will predict patient responses to the drug and hopes to launch both as a personalized medicine combination to optimize treatment outcomes.
Novacea (NOVC) has a PDUFA date of 7/30/09 for its Intermezzo (zolpidem sublingual lozenge) NDA for as-needed use to treat insomnia from middle of night awakenings.
Advanced Life Sciences (ADLS) has a PDUFA date of 8/1/09 for its cethromycin NDA, which is a once-daily antibiotic for the treatment of community acquired pneumonia.
NeurogesX (NGSX) has a PDUFA date of 8/22/09 for its Qutenza (NGX-4010) capsaicin skin patch NDA for post-herpetic neuralgia (nerve pain that occurs after shingles outbreak).
ISTA Pharma (ISTA) has a PDUFA date of 9/12/09 for its Bepreve (bepotastine) eye drop NDA for ocular itching associated with allergic conjunctivitis.
Spectrum Pharma (SPPI) + Cell Therapeutics (CTIC) have a PDUFA date of 4/2/09 for their Zevalin sBLA (priority review) as consolidation therapy in the treatment of follicular B-cell non-Hodgkin's lymphoma (NHL) if the patient experiences a response to first-line treatment. CTIC also plans to begin a rolling NDA submission for pixantrone during 1Q09 for the treatment of relapsed, aggressive NHL.
Angiotech Pharma (ANPI) expects a decision by mid-2009 for its Bio-Seal Lung Biopsy Track Plug 510(k) application.
Labopharm (DDSS) has a PDUFA of 7/18/09 for its rapid-onset trazodone (DDS-04A) 505(b)(2) application for the treatment of major depressive disorder, which represents a new formulation of an existing drug that is also available in generic formulations.
Tuesday, February 3, 2009
An Expanded Emerging Stem Cell Index
An Expanded Emerging Stem Cell Index
By Mike Havrilla on 2/3/09
ETF Innovators
The table at my website link below includes 32 companies in the ETF Innovators Emerging Stem Cell Index of U.S.-listed stocks with market caps below $250M. I will maintain the index with these 32 components and track the total market value and stock price changes as an indicator of investor and trader sentiment toward the stem cell and regenerative medicine space.
http://www.etfinnovators.com/2009/02/expanded-emerging-stem-cell-index.html
Below is a list of all 32 companies in descending order by market cap with a total value of $1.27B and an average stock price change of -15% over the past year for the index, as compared to losses of 20% for the Healthcare Sector SPDR (XLV), 4.7% for SPDR S&P Biotech (XBI), 9.1% for iShares Nasdaq Biotech (IBB), and 18.9% for PowerShares Biotech & Genome (PBE).
StemCells (STEM)
BioMimetic Therapeutics (BMTI)
RTI Biologics (RTIX) – announced an $11.75M financing ($10M credit facility + $1.75M term loan) on Monday to replace its previous line of credit and supplement the Company's working capital needs.
Cytori Therapeutics (CYTX) – commenced patient enrollment last week in an investigator-initiated 10-patient study using adipose-derived stem cells processed by Cytori's Celution 800 System to treat stress urinary incontinence.
Aastrom Biosciences (ASTM)
Mesoblast (MBLTY)
BioTime (BTIM) – biggest stock gain in past year (up over 700%)
Osteotech (OSTE)
Neuralstem (CUR)
RegeneRx Biopharma (RGN)
ThermoGenesis (KOOL) – will report its fiscal 2Q09 results tomorrow with a conference call after the market close at 5 pm (ET).
Athersys (ATHX)
Advanced Cell Technology (ACTC)
International Stem Cell Corp (ISCO)
Bioheart (BHRT) – up over 20% today on news of a grant-funded study in Italy for the Bioheart A&C Bio Science Twin-Pulsatile Life Support System which is expected to be completed within just 45 days with the potential for $2.1M in contract sales if results are positive.
Pluristem Therapeutics (PSTI)
HepaLife Technologies (HPLF)
Stem Cell Innovations (SCLL)
Isolagen (ILE)
CellCyte Genetics Corp (CCYG)
Cryo-Cell (CCEL)
Stem Cell Therapeutics (SCTPF)
Brainstorm Cell Therapeutics (BCLI)
Stem Cell Authority (SCAL)
Opexa Therapeutics (OPXA)
Neostem (NBS)
Bio-Matrix Scientific Group (BMSN)
Cord Blood America (CBAI)
MediStem (MEDS)
Stem Cell Therapy Internt'l (SCII)
MultiCell Technologies (MCET)
LifeStem International (LSTM)
By Mike Havrilla on 2/3/09
ETF Innovators
The table at my website link below includes 32 companies in the ETF Innovators Emerging Stem Cell Index of U.S.-listed stocks with market caps below $250M. I will maintain the index with these 32 components and track the total market value and stock price changes as an indicator of investor and trader sentiment toward the stem cell and regenerative medicine space.
http://www.etfinnovators.com/2009/02/expanded-emerging-stem-cell-index.html
Below is a list of all 32 companies in descending order by market cap with a total value of $1.27B and an average stock price change of -15% over the past year for the index, as compared to losses of 20% for the Healthcare Sector SPDR (XLV), 4.7% for SPDR S&P Biotech (XBI), 9.1% for iShares Nasdaq Biotech (IBB), and 18.9% for PowerShares Biotech & Genome (PBE).
StemCells (STEM)
BioMimetic Therapeutics (BMTI)
RTI Biologics (RTIX) – announced an $11.75M financing ($10M credit facility + $1.75M term loan) on Monday to replace its previous line of credit and supplement the Company's working capital needs.
Cytori Therapeutics (CYTX) – commenced patient enrollment last week in an investigator-initiated 10-patient study using adipose-derived stem cells processed by Cytori's Celution 800 System to treat stress urinary incontinence.
Aastrom Biosciences (ASTM)
Mesoblast (MBLTY)
BioTime (BTIM) – biggest stock gain in past year (up over 700%)
Osteotech (OSTE)
Neuralstem (CUR)
RegeneRx Biopharma (RGN)
ThermoGenesis (KOOL) – will report its fiscal 2Q09 results tomorrow with a conference call after the market close at 5 pm (ET).
Athersys (ATHX)
Advanced Cell Technology (ACTC)
International Stem Cell Corp (ISCO)
Bioheart (BHRT) – up over 20% today on news of a grant-funded study in Italy for the Bioheart A&C Bio Science Twin-Pulsatile Life Support System which is expected to be completed within just 45 days with the potential for $2.1M in contract sales if results are positive.
Pluristem Therapeutics (PSTI)
HepaLife Technologies (HPLF)
Stem Cell Innovations (SCLL)
Isolagen (ILE)
CellCyte Genetics Corp (CCYG)
Cryo-Cell (CCEL)
Stem Cell Therapeutics (SCTPF)
Brainstorm Cell Therapeutics (BCLI)
Stem Cell Authority (SCAL)
Opexa Therapeutics (OPXA)
Neostem (NBS)
Bio-Matrix Scientific Group (BMSN)
Cord Blood America (CBAI)
MediStem (MEDS)
Stem Cell Therapy Internt'l (SCII)
MultiCell Technologies (MCET)
LifeStem International (LSTM)
FDA Calendar: Two Advisory Panel Meetings
FDA Calendar: Two Advisory Panel Meetings
By Mike Havrilla on 2/3/09
ETF Innovators
The tables at my website link below feature an updated calendar of 79 expected FDA new product decisions and 91 pending clinical trial result estimates + pending FDA re-submissions or new submissions for regulatory approval. Click here for a link to my previous calendars.
http://www.etfinnovators.com/2009/02/fda-calendar-two-advisory-panel.html
1.) Eli Lilly (LLY) and Daiichi Sanky (DSKYY) have a FDA advisory panel meeting today to review their potential blockbuster blood thinner Effient (prasugrel) – click here for the PDF review document. The panel debate will center on safety issues for Effient, which has unquestioned effectiveness as a blood thinner to compete with the world's second best-selling drug, Plavix.
Rumors are also circulating that Sanofi-Aventis (SNY) may be considering a bid for its Plavix marketing partner, Bristol-Myers (BMY). While there are no doubts that Effient is effective as a blood thinner, safety concerns will limit the target population for the drug to avoid bleeding complications in high-risk patients.
2.) Dyax Corp (DYAX) will also face a FDA advisory panel vote on 2/4/09 for Kalbitor (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE), which as a PDUFA decision date of 3/23/09 for the priority review BLA. Summary documents (link to PDF) posted at the FDA website raise possible concerns over allergic reactions, which occurred at a 3% higher incidence among patients taking the drug, as well as the patient questionnaires used by the Company to assess patient outcomes.
3.) OraSure Technologies (OSUR): A pre-market approval application (PMA) was submitted in late October 2008 to the FDA for a new test, the OraQuick Hepatitis C Virus (HCV) Rapid Test, with a possible decision by late 2009, although there are no decision deadlines issued by the FDA for PMAs. Schering-Plough (SGP) will reimburse OSUR for a portion of the development expenses and help to market the test to physicians in the U.S. and international markets.
The HCV test is one of two key catalysts for OSUR in addition to the development of an oral fluid based diagnostic test for HIV being developed for over-the-counter (OTC) sale directly to consumers. OSUR recently received FDA approval for a 12-month shelf life from the date of manufacture for its OraQuick ADVANCE Rapid HIV-1/2 Antibody Test, which is already on the market for use by healthcare professionals.
The OTC test for HIV has been in development for years as OSUR must conduct clinical trials to establish that consumers are able to use the test and correctly interpret the results. Also, a strategy must be in place to provide follow-up support and healthcare referrals for those who test positive for the disease, based on input from the FDA Blood Products Advisory Panel in March 2006.
OSUR currently trades at a market cap of $128M despite net cash + investments of about $75M and revenue of about $54M through the first nine months of 2008. The HCV and HIV tests are crucial for the Company to restore profitability and long-term growth, as OSUR used $3.7M of cash flow for operating activities for the first three quarters of 2008. The Company also repurchased about $3M of its common stock in the last quarter while trading at multi-year lows.
By Mike Havrilla on 2/3/09
ETF Innovators
The tables at my website link below feature an updated calendar of 79 expected FDA new product decisions and 91 pending clinical trial result estimates + pending FDA re-submissions or new submissions for regulatory approval. Click here for a link to my previous calendars.
http://www.etfinnovators.com/2009/02/fda-calendar-two-advisory-panel.html
1.) Eli Lilly (LLY) and Daiichi Sanky (DSKYY) have a FDA advisory panel meeting today to review their potential blockbuster blood thinner Effient (prasugrel) – click here for the PDF review document. The panel debate will center on safety issues for Effient, which has unquestioned effectiveness as a blood thinner to compete with the world's second best-selling drug, Plavix.
Rumors are also circulating that Sanofi-Aventis (SNY) may be considering a bid for its Plavix marketing partner, Bristol-Myers (BMY). While there are no doubts that Effient is effective as a blood thinner, safety concerns will limit the target population for the drug to avoid bleeding complications in high-risk patients.
2.) Dyax Corp (DYAX) will also face a FDA advisory panel vote on 2/4/09 for Kalbitor (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE), which as a PDUFA decision date of 3/23/09 for the priority review BLA. Summary documents (link to PDF) posted at the FDA website raise possible concerns over allergic reactions, which occurred at a 3% higher incidence among patients taking the drug, as well as the patient questionnaires used by the Company to assess patient outcomes.
3.) OraSure Technologies (OSUR): A pre-market approval application (PMA) was submitted in late October 2008 to the FDA for a new test, the OraQuick Hepatitis C Virus (HCV) Rapid Test, with a possible decision by late 2009, although there are no decision deadlines issued by the FDA for PMAs. Schering-Plough (SGP) will reimburse OSUR for a portion of the development expenses and help to market the test to physicians in the U.S. and international markets.
The HCV test is one of two key catalysts for OSUR in addition to the development of an oral fluid based diagnostic test for HIV being developed for over-the-counter (OTC) sale directly to consumers. OSUR recently received FDA approval for a 12-month shelf life from the date of manufacture for its OraQuick ADVANCE Rapid HIV-1/2 Antibody Test, which is already on the market for use by healthcare professionals.
The OTC test for HIV has been in development for years as OSUR must conduct clinical trials to establish that consumers are able to use the test and correctly interpret the results. Also, a strategy must be in place to provide follow-up support and healthcare referrals for those who test positive for the disease, based on input from the FDA Blood Products Advisory Panel in March 2006.
OSUR currently trades at a market cap of $128M despite net cash + investments of about $75M and revenue of about $54M through the first nine months of 2008. The HCV and HIV tests are crucial for the Company to restore profitability and long-term growth, as OSUR used $3.7M of cash flow for operating activities for the first three quarters of 2008. The Company also repurchased about $3M of its common stock in the last quarter while trading at multi-year lows.
Monday, February 2, 2009
New Emerging Stem Cell Index
Shares of Geron (GERN) and other well known stem cell and regenerative medicine stocks such as Osiris Therapeutics (OSIR) and StemCells (STEM) have been soaring since the FDA allowed human clinical testing for Geron's embryonic stem cell treatment candidate for spinal cord injuries.
The table at my website link below highlights 25 U.S.-listed stem cell and regenerative medicine companies with market caps of below $200M which are included in the ETF Innovators Emerging Stem Cell Index. The companies are also listed below in descending order by market cap.
http://www.etfinnovators.com/2009/02/new-emerging-stem-cell-index.html
BioMimetic Therapeutics (BMTI)
Cytori Therapeutics (CYTX)
RTI Biologics (RTIX)
Aastrom Biosciences (ASTM)
Mesoblast (MBLTY)
Neuralstem (CUR)
Osteotech (OSTE)
ThermoGenesis (KOOL)
RegeneRx Biopharma (RGN)
Advanced Cell Tecchology (ACTC)
Pluristem Therapeutics (PSTI)
Athersys (ATHX)
International Stem Cell Corp (ISCO)
Stem Cell Innovations (SCLL)
Bioheart (BHRT)
CellCyte Genetics Corp (CCYG)
Stem Cell Therapeutics (SCTPF)
Brainstorm Cell Therapeutics (BCLI)
Opexa Therapeutics (OPXA)
Stem Cell Authority (SCAL)
Neostem (NBS)
Stem Cell Therapy Internt'l (SCII)
Cord Blood America (CBAI)
MultiCell Technologies (MCET)
LifeStem International (LSTM)
While regenerative medicine holds enormous potential for breakthrough medical treatments, investors and traders should be cautious as the entire space is an extreme momentum trade since the FDA news to allow human testing of embryonic stem cells. President Obama is also expected to lift the federal ban under the previous administration to allow federal funding of stem cell research, providing another boon to these companies.
Click here for my previous articles on stem cell investing, including my favorite two companies from this index – Cytori Therapeutics and ThermoGenesis, which are developing therapeutic and stem cell banking applications derived from a patient's own fat tissue and blood or bone marrow, respectively. Both of these companies already have products on the market, in addition to ongoing clinical studies for therapeutic applications of their stem cell and regenerative medicine systems and technology platforms.
The table at my website link below highlights 25 U.S.-listed stem cell and regenerative medicine companies with market caps of below $200M which are included in the ETF Innovators Emerging Stem Cell Index. The companies are also listed below in descending order by market cap.
http://www.etfinnovators.com/2009/02/new-emerging-stem-cell-index.html
BioMimetic Therapeutics (BMTI)
Cytori Therapeutics (CYTX)
RTI Biologics (RTIX)
Aastrom Biosciences (ASTM)
Mesoblast (MBLTY)
Neuralstem (CUR)
Osteotech (OSTE)
ThermoGenesis (KOOL)
RegeneRx Biopharma (RGN)
Advanced Cell Tecchology (ACTC)
Pluristem Therapeutics (PSTI)
Athersys (ATHX)
International Stem Cell Corp (ISCO)
Stem Cell Innovations (SCLL)
Bioheart (BHRT)
CellCyte Genetics Corp (CCYG)
Stem Cell Therapeutics (SCTPF)
Brainstorm Cell Therapeutics (BCLI)
Opexa Therapeutics (OPXA)
Stem Cell Authority (SCAL)
Neostem (NBS)
Stem Cell Therapy Internt'l (SCII)
Cord Blood America (CBAI)
MultiCell Technologies (MCET)
LifeStem International (LSTM)
While regenerative medicine holds enormous potential for breakthrough medical treatments, investors and traders should be cautious as the entire space is an extreme momentum trade since the FDA news to allow human testing of embryonic stem cells. President Obama is also expected to lift the federal ban under the previous administration to allow federal funding of stem cell research, providing another boon to these companies.
Click here for my previous articles on stem cell investing, including my favorite two companies from this index – Cytori Therapeutics and ThermoGenesis, which are developing therapeutic and stem cell banking applications derived from a patient's own fat tissue and blood or bone marrow, respectively. Both of these companies already have products on the market, in addition to ongoing clinical studies for therapeutic applications of their stem cell and regenerative medicine systems and technology platforms.
Cell Therapeutics: Down, but Not Out
Cell Therapeutics: Down, but Not Out
By Mike Havrilla on 2/2/09
Originally post at ETF Innovators website with web links
http://www.etfinnovators.com/2009/02/cell-therapeutics-down-but-not-out.html
Cell Therapeutics (CTIC) is a micro-cap cancer biotech which is down substantially in the past year in terms of stock price and market value, but not out after recently establishing a joint venture with Spectrum Pharma (SPPI) to market Zevalin, the potential for two FDA approvals this year (one new product, one label expansion), the potential for EMEA approval of Opaxio in the E.U., and a goal to become cash flow break-even by year-end.
A World Health Organization report released late last year estimates that cancer will overtake heart disease as the top cause of death in the world by 2010, which is part of an overall trend that predicts global cancer cases and deaths will more than double by 2030. The report predicts 27 million new cases of cancer will occur in 2030, which is a sharp increase from the 12 million cases of cancer in 2007.
Near-term events for CTIC include a special meeting for shareholders scheduled for 2/6/09 to obtain approval to increase the number of authorized shares of common stock (from 400M to 800M), conduct a reverse split (between 1:2-1:20), and increase the number of shares authorized for equity incentive + employee stock purchase plans – with the first two proposals aimed at regaining compliance for continued listing on the Nasdaq Capital Market by a deadline of 2/12/09. CTIC will also be presenting at the 11th Annual BIO CEO & Investor Conference on Tuesday, February 10th at 9:30 AM in the Jade Room of the Waldorf-Astoria Hotel in New York City – click here for a link to the webcast for this event.
CTIC and SPPI have an upcoming PDUFA decision date (one of 14 extreme FDA trades, including companies with market caps below $100M with pending regulatory decisions) of 4/2/09 with a priority review designation for their sBLA to expand the label of Zevalin (Ibritumomab Tiuxetan) as consolidation therapy after remission induction in previously untreated patients with follicular non-Hodgkin's lymphoma (NHL). Zevalin is currently approved for the treatment of relapsed or refractory low-grade or follicular B-cell NHL, which is now being marketed by the 50/50 joint venture between CTIC and SPPI called RIT Oncology.
CTIC received $15M in cash along with a 50% interest as part of the agreement with SPPI to form the joint venture to further develop and market Zevalin. CTIC is also eligible to receive an additional $15M in milestone payments based on achieving sales targets for the drug while doubling the size of the sales and marketing team behind the drug. There is also an option for CTIC to sell its 50% interest in RIT Oncology to SPPI for $18M at any time from 1/15/09 to 7/15/09, which is an important feature of the deal since CTIC has indicated that it will require additional financing during 2009 and the low stock price precludes equity-based financings.
In late January, CTIC announced that its plans to begin submission of a rolling NDA for pixantrone (BBR-2778) during 1Q09 for the treatment of relapsed, aggressive NHL – with FDA approval possible before year-end if a priority review is granted by the agency. There is a high likelihood of a priority review for this indication since it represents an unmet medical need with no currently approved drugs on the market. Last November, CTIC reported Phase 3 clinical trial results for pixantrone, which achieved its primary and secondary efficacy endpoints under a Special Protocol Assessment (SPA) approval by the FDA for the study.
Patients randomized to receive pixantrone in the study achieved an 11% (8 of 70) rate of confirmed complete remissions, as compared to no patients (out of 70) who were randomized to receive standard chemotherapy. Pixantrone also achieved a higher overall response rate of 37.1% (26 of 70) compared to patients received standard chemo at 14.3% (10 of 70). Patients receiving pixantrone also demonstrated a statistically significant improvement in progression-free survival compared to standard chemo (4.7 months versus 2.6 months). The FDA approval and launch of pixantrone could result in upfront + milestone payments from Novartis (NVS) if NVS chooses to exercise its exclusive, worldwide license to commercialize pixantrone.
Pixantrone is less damaging to the heart compared to the widely used and effective class of chemo drugs called anthracyclines and has demonstrated synergistic activity when combined with Rituxan and other treatments. Pixantrone also offers advantages in the way it is delivered (via regular IV infusion), compared to other agents which require pre-medication and central lines to administer.
Opaxio (paclitaxel poliglumex, CT-2103, formerly Xyotax) has a pending marketing authorization application (MAA) to the European Medicines Agency (EMEA) which was filed in March 2008 for the first-line treatment of patients with non-small cell lung cancer (NSCLC) (with performance status 2) as part of an exclusive licensing deal with NVS. Opaxio is designed to reduce the side effects of paclitaxel by linking it to a biodegradable polymer to create a new chemical entity which results in targeted delivery to solid tumors such as breast, ovarian, and lung cancers.
Clinical studies suggest that the metabolism of Opaxio by lung cancer cells may be influenced by estrogen, resulting in higher levels of the drug in women with lung cancer and the potential for increased efficacy. The MAA was filed based on non-inferiority or equivalent effectiveness + an improved safety profile for the treatment of NSCLC while the U.S. regulatory strategy will seek approval for maintenance treatment of ovarian cancer following complete remission after first-line treatment.
Brostallicin is currently in Phase 2 clinical development as a new type of synthetic cancer drug (a DNA minor groove binding agent) which has the potential to be a highly selective cancer treatment which is synergistic with standard chemo drugs and newer targeted therapies. CTIC owns the exclusive, worldwide rights to brostallicin and has completed six clinical trials for the drug, with results for three of the trials still pending.
While shares of CTIC have declined sharply in the past year, 2009 holds the promise for better days with the potential for three regulatory approvals (Zevalin sBLA, Pixantrone NDA, and Opaxio MAA), the potential for increased Zevalin sales from the RTI Oncology joint venture, the option to sell its stake in the joint venture to SPPI for $18M through mid-July, and the goal of becoming cash flow break-even by year-end.
EXACT Sciences (EXAS) provides a useful comparison of a micro-cap cancer diagnostics company which traded as low as 22 cents late last year and now trades around $1.50 thanks to a hostile takeover bid by Sequenom (SQNM) and a subsequent licensing deal with Genzyme (GENZ) which included a $24.5M cash infusion and an extensive collaboration for product development and marketing.
By Mike Havrilla on 2/2/09
Originally post at ETF Innovators website with web links
http://www.etfinnovators.com/2009/02/cell-therapeutics-down-but-not-out.html
Cell Therapeutics (CTIC) is a micro-cap cancer biotech which is down substantially in the past year in terms of stock price and market value, but not out after recently establishing a joint venture with Spectrum Pharma (SPPI) to market Zevalin, the potential for two FDA approvals this year (one new product, one label expansion), the potential for EMEA approval of Opaxio in the E.U., and a goal to become cash flow break-even by year-end.
A World Health Organization report released late last year estimates that cancer will overtake heart disease as the top cause of death in the world by 2010, which is part of an overall trend that predicts global cancer cases and deaths will more than double by 2030. The report predicts 27 million new cases of cancer will occur in 2030, which is a sharp increase from the 12 million cases of cancer in 2007.
Near-term events for CTIC include a special meeting for shareholders scheduled for 2/6/09 to obtain approval to increase the number of authorized shares of common stock (from 400M to 800M), conduct a reverse split (between 1:2-1:20), and increase the number of shares authorized for equity incentive + employee stock purchase plans – with the first two proposals aimed at regaining compliance for continued listing on the Nasdaq Capital Market by a deadline of 2/12/09. CTIC will also be presenting at the 11th Annual BIO CEO & Investor Conference on Tuesday, February 10th at 9:30 AM in the Jade Room of the Waldorf-Astoria Hotel in New York City – click here for a link to the webcast for this event.
CTIC and SPPI have an upcoming PDUFA decision date (one of 14 extreme FDA trades, including companies with market caps below $100M with pending regulatory decisions) of 4/2/09 with a priority review designation for their sBLA to expand the label of Zevalin (Ibritumomab Tiuxetan) as consolidation therapy after remission induction in previously untreated patients with follicular non-Hodgkin's lymphoma (NHL). Zevalin is currently approved for the treatment of relapsed or refractory low-grade or follicular B-cell NHL, which is now being marketed by the 50/50 joint venture between CTIC and SPPI called RIT Oncology.
CTIC received $15M in cash along with a 50% interest as part of the agreement with SPPI to form the joint venture to further develop and market Zevalin. CTIC is also eligible to receive an additional $15M in milestone payments based on achieving sales targets for the drug while doubling the size of the sales and marketing team behind the drug. There is also an option for CTIC to sell its 50% interest in RIT Oncology to SPPI for $18M at any time from 1/15/09 to 7/15/09, which is an important feature of the deal since CTIC has indicated that it will require additional financing during 2009 and the low stock price precludes equity-based financings.
In late January, CTIC announced that its plans to begin submission of a rolling NDA for pixantrone (BBR-2778) during 1Q09 for the treatment of relapsed, aggressive NHL – with FDA approval possible before year-end if a priority review is granted by the agency. There is a high likelihood of a priority review for this indication since it represents an unmet medical need with no currently approved drugs on the market. Last November, CTIC reported Phase 3 clinical trial results for pixantrone, which achieved its primary and secondary efficacy endpoints under a Special Protocol Assessment (SPA) approval by the FDA for the study.
Patients randomized to receive pixantrone in the study achieved an 11% (8 of 70) rate of confirmed complete remissions, as compared to no patients (out of 70) who were randomized to receive standard chemotherapy. Pixantrone also achieved a higher overall response rate of 37.1% (26 of 70) compared to patients received standard chemo at 14.3% (10 of 70). Patients receiving pixantrone also demonstrated a statistically significant improvement in progression-free survival compared to standard chemo (4.7 months versus 2.6 months). The FDA approval and launch of pixantrone could result in upfront + milestone payments from Novartis (NVS) if NVS chooses to exercise its exclusive, worldwide license to commercialize pixantrone.
Pixantrone is less damaging to the heart compared to the widely used and effective class of chemo drugs called anthracyclines and has demonstrated synergistic activity when combined with Rituxan and other treatments. Pixantrone also offers advantages in the way it is delivered (via regular IV infusion), compared to other agents which require pre-medication and central lines to administer.
Opaxio (paclitaxel poliglumex, CT-2103, formerly Xyotax) has a pending marketing authorization application (MAA) to the European Medicines Agency (EMEA) which was filed in March 2008 for the first-line treatment of patients with non-small cell lung cancer (NSCLC) (with performance status 2) as part of an exclusive licensing deal with NVS. Opaxio is designed to reduce the side effects of paclitaxel by linking it to a biodegradable polymer to create a new chemical entity which results in targeted delivery to solid tumors such as breast, ovarian, and lung cancers.
Clinical studies suggest that the metabolism of Opaxio by lung cancer cells may be influenced by estrogen, resulting in higher levels of the drug in women with lung cancer and the potential for increased efficacy. The MAA was filed based on non-inferiority or equivalent effectiveness + an improved safety profile for the treatment of NSCLC while the U.S. regulatory strategy will seek approval for maintenance treatment of ovarian cancer following complete remission after first-line treatment.
Brostallicin is currently in Phase 2 clinical development as a new type of synthetic cancer drug (a DNA minor groove binding agent) which has the potential to be a highly selective cancer treatment which is synergistic with standard chemo drugs and newer targeted therapies. CTIC owns the exclusive, worldwide rights to brostallicin and has completed six clinical trials for the drug, with results for three of the trials still pending.
While shares of CTIC have declined sharply in the past year, 2009 holds the promise for better days with the potential for three regulatory approvals (Zevalin sBLA, Pixantrone NDA, and Opaxio MAA), the potential for increased Zevalin sales from the RTI Oncology joint venture, the option to sell its stake in the joint venture to SPPI for $18M through mid-July, and the goal of becoming cash flow break-even by year-end.
EXACT Sciences (EXAS) provides a useful comparison of a micro-cap cancer diagnostics company which traded as low as 22 cents late last year and now trades around $1.50 thanks to a hostile takeover bid by Sequenom (SQNM) and a subsequent licensing deal with Genzyme (GENZ) which included a $24.5M cash infusion and an extensive collaboration for product development and marketing.
Saturday, January 31, 2009
OraSure: Two Diagnostic Tests to Fuel Growth
OraSure: Two Diagnostic Tests to Fuel Growth
By Mike Havrilla on 1/31/09
http://www.etfinnovators.com/2009/01/orasure-two-diagnostic-tests-to-fuel.html
With shares of CombiMatrix (CBMX) moving up by over 10% since I profiled the company in mid-January as a long-term buy from the ETF Innovators Emerging Diagnostics Index; a similar opportunity exists today with shares of OraSure Technologies (OSUR). OSUR is a leader in oral fluid diagnostics and also offers cryosurgical systems to remove warts through freezing, which are sold in different forms both directly to consumers and to physicians.
OSUR has lost nearly two-thirds of its market value over the past year and currently trades at a slight discount to its book value, closing out the month at just $2.88 per share. OSUR has $85.4M in cash, $8.4M in debt, $74M in trailing 12-month revenue, and posted a net loss of $2M over the past year. The Company has about 47M shares of common stock outstanding on a fully diluted basis and a market cap of $132M through the end of January.
OSUR recently received FDA approval for a 12-month shelf life from the date of manufacture for its OraQuick ADVANCE Rapid HIV-1/2 Antibody Test, which is twice as long as the previous version and will be ready for shipment by March. OraQuick ADVANCE is the first and only FDA-approved and CLIA-waived test for the rapid detection of antibodies to both HIV-1 and HIV-2 in just 20 minutes. The test is also flexible, with the ability to accept a variety of samples such as oral fluids, whole blood, and plasma.
The Company also offers Intercept as an FDA approved oral fluid drug testing system, which provides an alternative to urine testing for a panel consisting of commonly abused drugs that are tested in conjunction with pre-employment screening and other settings. The Q.E.D. Saliva Alcohol Test provides an alternative to breathalyzer or blood-based tests to determine blood alcohol levels.
For 3Q08, OSUR posted an 18% sales increase for the OraQuick ADVANCE rapid HIV test as it also terminated its distribution agreement with Abbott Labs (ABT) and will began selling the test directly to U.S. hospitals and labs in 2009 while utilizing distributors for selling directly to physicians. OSUR repurchased $3.1M shares of its stock during the quarter and the sales breakdown for the first nine months of 2008 includes 54% infectious disease testing, 20% substance abuse testing, 14% cryosurgical systems, 8% insurance risk assessment, and 4% licensing revenue.
A pre-market approval application (PMA) was submitted in late October 2008 to the FDA for a new test, the OraQuick Hepatitis C Virus (HCV) Rapid Test, with a possible decision by late 2009, although there are no decision deadlines issued by the FDA for PMAs. Schering-Plough (SGP) will reimburse OSUR for a portion of the development expenses and help to market the test to physicians in the U.S. and international markets.
If approved, the HCV test would represent the first FDA approved rapid HCV test in the U.S. for a chronic disease with an estimated prevalence which is four-fold higher than HIV or 180 million people worldwide. According to World Health Organization statistics, 50% of people with HCV are undiagnosed and over three-quarters have no symptoms while the Centers for Disease Control and Prevention (CDC) estimates 19,000 new cases of HCV occurred in 2006, although the actual number of cases reported was much lower since the majority of those infected with HCV are unaware and display no symptoms.
The other major catalyst for OSUR is the development of an over-the-counter (OTC) version of its OraQuick HIV test, which will culminate in a FDA submission for approval. The OTC test for HIV has been in development for years as OSUR must conduct clinical trials to establish that consumers are able to use the test and correctly interpret the results. Also, a strategy must be in place to provide follow-up support and healthcare referrals for those who test positive for the disease, based on input from the FDA Blood Products Advisory Panel in March 2006.
The market for an OTC test for HIV would be enormous, as the CDC issued revised HIV screening recommendations in September 2006 that recommended routine screening for all patients 13 – 64 years old unless they choose to opt-out, which includes a population of over 200 million people in the United States. The CDC estimates that 16 – 22 million people are currently tested for HIV annually in the United States, with a goal of increased screening rates to reduce the risk of spreading the disease and initiate treatment as soon as possible.
Also, since the OraQuick platform is non-invasive (oral fluid testing) and easy to use, OSUR could expand its testing platform to detect other sexually transmitted diseases and possibly sell the tests on an OTC basis directly to consumers. However, the key catalysts over the next year or so will be gaining approval of the HCV test and submitting the HIV test to the FDA for sale to consumers on an OTC basis.
For those who are willing to invest for the long-term, OSUR has a strong balance sheet and cash flow from operations which are sufficient to achieve the two catalysts required for future growth – approval of the HCV test for sale to physicians and submission of the HIV test for OTC sale to consumers.
By Mike Havrilla on 1/31/09
http://www.etfinnovators.com/2009/01/orasure-two-diagnostic-tests-to-fuel.html
With shares of CombiMatrix (CBMX) moving up by over 10% since I profiled the company in mid-January as a long-term buy from the ETF Innovators Emerging Diagnostics Index; a similar opportunity exists today with shares of OraSure Technologies (OSUR). OSUR is a leader in oral fluid diagnostics and also offers cryosurgical systems to remove warts through freezing, which are sold in different forms both directly to consumers and to physicians.
OSUR has lost nearly two-thirds of its market value over the past year and currently trades at a slight discount to its book value, closing out the month at just $2.88 per share. OSUR has $85.4M in cash, $8.4M in debt, $74M in trailing 12-month revenue, and posted a net loss of $2M over the past year. The Company has about 47M shares of common stock outstanding on a fully diluted basis and a market cap of $132M through the end of January.
OSUR recently received FDA approval for a 12-month shelf life from the date of manufacture for its OraQuick ADVANCE Rapid HIV-1/2 Antibody Test, which is twice as long as the previous version and will be ready for shipment by March. OraQuick ADVANCE is the first and only FDA-approved and CLIA-waived test for the rapid detection of antibodies to both HIV-1 and HIV-2 in just 20 minutes. The test is also flexible, with the ability to accept a variety of samples such as oral fluids, whole blood, and plasma.
The Company also offers Intercept as an FDA approved oral fluid drug testing system, which provides an alternative to urine testing for a panel consisting of commonly abused drugs that are tested in conjunction with pre-employment screening and other settings. The Q.E.D. Saliva Alcohol Test provides an alternative to breathalyzer or blood-based tests to determine blood alcohol levels.
For 3Q08, OSUR posted an 18% sales increase for the OraQuick ADVANCE rapid HIV test as it also terminated its distribution agreement with Abbott Labs (ABT) and will began selling the test directly to U.S. hospitals and labs in 2009 while utilizing distributors for selling directly to physicians. OSUR repurchased $3.1M shares of its stock during the quarter and the sales breakdown for the first nine months of 2008 includes 54% infectious disease testing, 20% substance abuse testing, 14% cryosurgical systems, 8% insurance risk assessment, and 4% licensing revenue.
A pre-market approval application (PMA) was submitted in late October 2008 to the FDA for a new test, the OraQuick Hepatitis C Virus (HCV) Rapid Test, with a possible decision by late 2009, although there are no decision deadlines issued by the FDA for PMAs. Schering-Plough (SGP) will reimburse OSUR for a portion of the development expenses and help to market the test to physicians in the U.S. and international markets.
If approved, the HCV test would represent the first FDA approved rapid HCV test in the U.S. for a chronic disease with an estimated prevalence which is four-fold higher than HIV or 180 million people worldwide. According to World Health Organization statistics, 50% of people with HCV are undiagnosed and over three-quarters have no symptoms while the Centers for Disease Control and Prevention (CDC) estimates 19,000 new cases of HCV occurred in 2006, although the actual number of cases reported was much lower since the majority of those infected with HCV are unaware and display no symptoms.
The other major catalyst for OSUR is the development of an over-the-counter (OTC) version of its OraQuick HIV test, which will culminate in a FDA submission for approval. The OTC test for HIV has been in development for years as OSUR must conduct clinical trials to establish that consumers are able to use the test and correctly interpret the results. Also, a strategy must be in place to provide follow-up support and healthcare referrals for those who test positive for the disease, based on input from the FDA Blood Products Advisory Panel in March 2006.
The market for an OTC test for HIV would be enormous, as the CDC issued revised HIV screening recommendations in September 2006 that recommended routine screening for all patients 13 – 64 years old unless they choose to opt-out, which includes a population of over 200 million people in the United States. The CDC estimates that 16 – 22 million people are currently tested for HIV annually in the United States, with a goal of increased screening rates to reduce the risk of spreading the disease and initiate treatment as soon as possible.
Also, since the OraQuick platform is non-invasive (oral fluid testing) and easy to use, OSUR could expand its testing platform to detect other sexually transmitted diseases and possibly sell the tests on an OTC basis directly to consumers. However, the key catalysts over the next year or so will be gaining approval of the HCV test and submitting the HIV test to the FDA for sale to consumers on an OTC basis.
For those who are willing to invest for the long-term, OSUR has a strong balance sheet and cash flow from operations which are sufficient to achieve the two catalysts required for future growth – approval of the HCV test for sale to physicians and submission of the HIV test for OTC sale to consumers.
ThermoGenesis: A Stealth Stem Cell Play
ThermoGenesis: A Stealth Stem Cell Play
By Mike Havrilla on 1/31/09
Link to Original Post at ETF Innovators Website:
http://www.etfinnovators.com/2009/01/thermogenesis-stealth-stem-cell-play.html
For investors in search of a play on stem cells and regenerative medicine who are unsure about committing capital to stocks which have already soared over the past few weeks such as StemCells (STEM), Geron (GERN), Osiris Therapeutics (OSIR), and Cytori Therapeutics (CYTX); ThermoGenesis (KOOL) represents an under-the-radar name which already has products on the market and in late-stage development. As illustrated in the accompanying chart (click to enlarge), KOOL has significantly lagged behind its peer group in terms of stock price performance over the past year despite having a strong balance sheet with a goal of achieving profitability by 4Q09.
KOOL recently embarked on a reorganization which includes a management transition plus financial goals for achieving 10%-20% revenue growth in FY09 and profitability by 4Q09 with gross margins of at least 40%. Key milestones for the year include adding new AutoXpress Platform (AXP) customers, controlling operating expenses, receiving FDA okay for the correction of manufacturing issues which led to an AXP bag set recall, initiating shipments of MarrowXpress (MXP) system + disposables this quarter through a new distribution agreement with Spine Smith, and the marketing of Res-Q for bone marrow + platelets during 3Q09 (veterinary applications in horses) and 4Q09 (human applications).
In the past three months, insiders have been heavy buyers of KOOL stock, accumulating 301,000 shares within a price range of $0.50-$0.56 per share. KOOL achieved 31% revenue growth for FY08, with more than half of their sales coming in the form of recurring disposables used in conjunction with the Company's systems and devices. KOOL enjoys a strong balance sheet, which includes $22.3M in cash + investments with zero debt, compared to a market cap of $43M at the end of January, trailing 12-month revenue of $22.8M, and a $9.6M net loss over the past year.
KOOL provides systems to process a patient's or an animal's own adipose (fat) tissue, bone marrow, and peripheral blood for a wide variety of medical applications, including:
- wound care applications (CryoSeal Fibrin Sealant, Thrombin Processing Device)
- stem cell and tissue banking (BioArchive)
- cord blood stem cell transplants
- regenerative medicine applications (see table below from KOOL presentation)
- the veterinary market (horses – Vantus brand) (MarrowXpress or MXP, Res-Q)
- stem cell processing (AXP: including Res-Q + MXP – bone marrow, Res-Q – peripheral blood, APS – adipose tissue)
While its stock price has lagged behind other stem cell companies over the past year, the strong balance sheet, robust product + development line-up, and the favorable outlook on stem cell research by the new administration bode well for KOOL in the coming year – especially if the Company can deliver on its goal of achieving profitability.
By Mike Havrilla on 1/31/09
Link to Original Post at ETF Innovators Website:
http://www.etfinnovators.com/2009/01/thermogenesis-stealth-stem-cell-play.html
For investors in search of a play on stem cells and regenerative medicine who are unsure about committing capital to stocks which have already soared over the past few weeks such as StemCells (STEM), Geron (GERN), Osiris Therapeutics (OSIR), and Cytori Therapeutics (CYTX); ThermoGenesis (KOOL) represents an under-the-radar name which already has products on the market and in late-stage development. As illustrated in the accompanying chart (click to enlarge), KOOL has significantly lagged behind its peer group in terms of stock price performance over the past year despite having a strong balance sheet with a goal of achieving profitability by 4Q09.
KOOL recently embarked on a reorganization which includes a management transition plus financial goals for achieving 10%-20% revenue growth in FY09 and profitability by 4Q09 with gross margins of at least 40%. Key milestones for the year include adding new AutoXpress Platform (AXP) customers, controlling operating expenses, receiving FDA okay for the correction of manufacturing issues which led to an AXP bag set recall, initiating shipments of MarrowXpress (MXP) system + disposables this quarter through a new distribution agreement with Spine Smith, and the marketing of Res-Q for bone marrow + platelets during 3Q09 (veterinary applications in horses) and 4Q09 (human applications).
In the past three months, insiders have been heavy buyers of KOOL stock, accumulating 301,000 shares within a price range of $0.50-$0.56 per share. KOOL achieved 31% revenue growth for FY08, with more than half of their sales coming in the form of recurring disposables used in conjunction with the Company's systems and devices. KOOL enjoys a strong balance sheet, which includes $22.3M in cash + investments with zero debt, compared to a market cap of $43M at the end of January, trailing 12-month revenue of $22.8M, and a $9.6M net loss over the past year.
KOOL provides systems to process a patient's or an animal's own adipose (fat) tissue, bone marrow, and peripheral blood for a wide variety of medical applications, including:
- wound care applications (CryoSeal Fibrin Sealant, Thrombin Processing Device)
- stem cell and tissue banking (BioArchive)
- cord blood stem cell transplants
- regenerative medicine applications (see table below from KOOL presentation)
- the veterinary market (horses – Vantus brand) (MarrowXpress or MXP, Res-Q)
- stem cell processing (AXP: including Res-Q + MXP – bone marrow, Res-Q – peripheral blood, APS – adipose tissue)
While its stock price has lagged behind other stem cell companies over the past year, the strong balance sheet, robust product + development line-up, and the favorable outlook on stem cell research by the new administration bode well for KOOL in the coming year – especially if the Company can deliver on its goal of achieving profitability.
Friday, January 30, 2009
Caraco Pharma Awaits FDA Inspection
With shares of Hi-Tech Pharmacal (HITK) already up about 20% since I profiled the Company as a value play two days ago, investors interested in the small-cap generic drug industry should take a look at Caraco Pharma (CPD) today at around 5 bucks. CPD reported results for its fiscal 3Q09 yesterday, including $55.7M in revenue and net income of $5.1M, which was down from the year-ago period revenue of $81.9M and net income of $10.8M. The year-ago period benefited substantially from the 180-day exclusivity period associated with the generic drug launch of oxcarbazepine (Trileptal) in conjunction with Sun Pharma (India: 524715).
Caraco noted that full-year revenue for fiscal 2009 is expected to be about the same as the previous year, reflecting uncertainty over the at-risk launch of generic Protonix (pantoprazole) and lower sales of oxcarbazepine since the exclusivity period has ended. Gross profit margin through the first nine months of FY09 declined to 21% from 36% in the year-ago period due to a higher mix of sales from distributed products, which have a much lower margin compared to manufactured products, with the latter posting 48% profit margin for the fiscal year to-date.
For the first nine months of FY09, Caraco filed six abbreviated new drug applications (ANDAs) related to five new generic drug products with a total of 25 pending ANDAs related to 21 new generic drug products. Caraco ended the calendar year with $34M in cash and $104M in working capital and expects cash flow from operations will be sufficient to fund its business plans, including the expansion of manufacturing facilities in Detroit which is nearly complete. Caraco is currently debt free and would only consider taking on debt for strategic acquisitions.
The major overhang on the stock price is the FDA warning letter related to Form 483 concerns by the agency related to an inspection of manufacturing facilities and quality control concerns. Caraco has already responded in full to the warning letter and the FDA will evaluate the corrective actions taken by the Company at its next scheduled inspection (although the exact date was not disclosed) of the Detroit manufacturing facility in question. The Company noted that the FDA did not require additional meetings and Caraco has made changes to its leadership in the areas of manufacturing and quality control since the warning letter.
The warning letter does not impact the sale of products which are already on the market, eliminating any concerns of a blow-up like the situation at KV Pharma (KV-A). Based on personnel changes and improvements in training and equipment, Caraco believes it is compliant with the FDA's cGMP regulations related to manufacturing and quality control. Once the FDA completes its inspection and is satisfied with the corrective actions, Caraco will be eligible to receive new generic drug product approvals from the Detroit facility and remove all uncertainties related to quality control and manufacturing, which could result in the stock price finding its way back to double digits around the 200-day moving average of 10 bucks.
In addition, India's largest generic drug maker by market cap, Sun Pharma, acquired 1.1M shares at year end, increasing its ownership stake in Caraco to over 50% (17.7M shares owned versus about 35M shares outstanding). Given this majority stake and the strong business ties between the two companies, Sun Pharma may even decide to buy out the remaining stake in its smaller partner at a nice premium to the current value prices (with an enterprise value to EBITDA ratio of less than 4X) since Caraco functions as a U.S. subsidiary of Sun to a large extent in terms of product distribution.
Caraco noted that full-year revenue for fiscal 2009 is expected to be about the same as the previous year, reflecting uncertainty over the at-risk launch of generic Protonix (pantoprazole) and lower sales of oxcarbazepine since the exclusivity period has ended. Gross profit margin through the first nine months of FY09 declined to 21% from 36% in the year-ago period due to a higher mix of sales from distributed products, which have a much lower margin compared to manufactured products, with the latter posting 48% profit margin for the fiscal year to-date.
For the first nine months of FY09, Caraco filed six abbreviated new drug applications (ANDAs) related to five new generic drug products with a total of 25 pending ANDAs related to 21 new generic drug products. Caraco ended the calendar year with $34M in cash and $104M in working capital and expects cash flow from operations will be sufficient to fund its business plans, including the expansion of manufacturing facilities in Detroit which is nearly complete. Caraco is currently debt free and would only consider taking on debt for strategic acquisitions.
The major overhang on the stock price is the FDA warning letter related to Form 483 concerns by the agency related to an inspection of manufacturing facilities and quality control concerns. Caraco has already responded in full to the warning letter and the FDA will evaluate the corrective actions taken by the Company at its next scheduled inspection (although the exact date was not disclosed) of the Detroit manufacturing facility in question. The Company noted that the FDA did not require additional meetings and Caraco has made changes to its leadership in the areas of manufacturing and quality control since the warning letter.
The warning letter does not impact the sale of products which are already on the market, eliminating any concerns of a blow-up like the situation at KV Pharma (KV-A). Based on personnel changes and improvements in training and equipment, Caraco believes it is compliant with the FDA's cGMP regulations related to manufacturing and quality control. Once the FDA completes its inspection and is satisfied with the corrective actions, Caraco will be eligible to receive new generic drug product approvals from the Detroit facility and remove all uncertainties related to quality control and manufacturing, which could result in the stock price finding its way back to double digits around the 200-day moving average of 10 bucks.
In addition, India's largest generic drug maker by market cap, Sun Pharma, acquired 1.1M shares at year end, increasing its ownership stake in Caraco to over 50% (17.7M shares owned versus about 35M shares outstanding). Given this majority stake and the strong business ties between the two companies, Sun Pharma may even decide to buy out the remaining stake in its smaller partner at a nice premium to the current value prices (with an enterprise value to EBITDA ratio of less than 4X) since Caraco functions as a U.S. subsidiary of Sun to a large extent in terms of product distribution.
Crucell: An Excellent Shot at a Buyout
As the largest pure-play vaccine company with a market cap of $1.2B (U.S. Dollar), Crucell (CRXL) represents a likely takeover target some time this year since the bid from Wyeth (WYE) fell through after the Pfizer (PFE) deal. Crucell offers a technology platform, development pipeline, marketed vaccines, a specialized sales force, and in-house manufacturing facilities.
As a component in the ETF Innovators Preventive Medicine Index, CRXL is also poised to benefit from a trend in healthcare to increase resources toward preventing disease as a way to reduce the cost and complications of treating medical conditions after they arise.
Since Pfizer cited Wyeth's vaccine and biological agents as one of the reasons for its acquisition, PFE may be interested in a bid for CRXL. Other names who would likely be interested in CRXL include:
- Merck (MRK): MRK could bolster its vaccine division to expand beyond the successful launch of cervical cancer vaccine Gardasil as the Company waits on the FDA to expand the label to include older women and males.
- Novartis (NVS) and Sanofi-Aventis (SNY) represent existing strategic partners with CRXL who are also based in Europe and would likely consider making a bid.
- GlaxoSmithKline (GSK): GSK is also developing a cervical cancer vaccine (Cervarix) to compete with Gardasil and CRXL would expand upon their pipeline and marketed vaccines.
The upside for CRXL is likely around 50% from the $18 U.S. stock price as of today, based on a premium to the previous Wyeth deal (reported at an initial value of $1.35B), which had CRXL trading near 24 bucks. Considering that a buyout for CRXL would likely involve multiple bidders such as the companies outlined above, a $27 price target is easily attainable in a takeover scenario given the scarcity of pure-play vaccine makers with the size and scope of CRXL + the quest for growth by big pharma companies such as Pfizer from biological agents and vaccines instead of the traditional drug product route.
CRXL offers a variety of proprietary development platforms, which revolve around their core technology platform called PER.C6 (a high-yield, large-scale, low-cost human cell line system for the production of vaccines, therapeutic proteins, and monoclonal antibodies), AdVac (utilizes fragments of the common cold virus to deliver vaccines), MAbstract (fully humanized antibodies for application in vaccines against rabies, SARS, and West Nile virus), and STAR (a gene expression technology with the potential for 5-10 fold greater antibody or therapeutic protein yields from mammalian cell lines).
Last November, CRXL reported robust 3Q08 results, which included net income of about $15M, 31% revenue growth, and 50% gross margins. CRXL guided for 25%-30% revenue growth and higher margins for 2008 full-year results. The Company also guided for positive year-end cash flow despite a significant investments to build inventories and continue clinical development initiatives.
CRXL offers robust fundamentals as a pure-play on preventive medicine in the form of vaccines and a valuable technology platform for the production of therapeutic proteins and monoclonal antibodies. For these reasons and the previous Wyeth bid, CRXL is poised to be acquired some time this year by one of its larger rivals outlined earlier as part of widespread M&A this year in the healthcare sector.
As a component in the ETF Innovators Preventive Medicine Index, CRXL is also poised to benefit from a trend in healthcare to increase resources toward preventing disease as a way to reduce the cost and complications of treating medical conditions after they arise.
Since Pfizer cited Wyeth's vaccine and biological agents as one of the reasons for its acquisition, PFE may be interested in a bid for CRXL. Other names who would likely be interested in CRXL include:
- Merck (MRK): MRK could bolster its vaccine division to expand beyond the successful launch of cervical cancer vaccine Gardasil as the Company waits on the FDA to expand the label to include older women and males.
- Novartis (NVS) and Sanofi-Aventis (SNY) represent existing strategic partners with CRXL who are also based in Europe and would likely consider making a bid.
- GlaxoSmithKline (GSK): GSK is also developing a cervical cancer vaccine (Cervarix) to compete with Gardasil and CRXL would expand upon their pipeline and marketed vaccines.
The upside for CRXL is likely around 50% from the $18 U.S. stock price as of today, based on a premium to the previous Wyeth deal (reported at an initial value of $1.35B), which had CRXL trading near 24 bucks. Considering that a buyout for CRXL would likely involve multiple bidders such as the companies outlined above, a $27 price target is easily attainable in a takeover scenario given the scarcity of pure-play vaccine makers with the size and scope of CRXL + the quest for growth by big pharma companies such as Pfizer from biological agents and vaccines instead of the traditional drug product route.
CRXL offers a variety of proprietary development platforms, which revolve around their core technology platform called PER.C6 (a high-yield, large-scale, low-cost human cell line system for the production of vaccines, therapeutic proteins, and monoclonal antibodies), AdVac (utilizes fragments of the common cold virus to deliver vaccines), MAbstract (fully humanized antibodies for application in vaccines against rabies, SARS, and West Nile virus), and STAR (a gene expression technology with the potential for 5-10 fold greater antibody or therapeutic protein yields from mammalian cell lines).
Last November, CRXL reported robust 3Q08 results, which included net income of about $15M, 31% revenue growth, and 50% gross margins. CRXL guided for 25%-30% revenue growth and higher margins for 2008 full-year results. The Company also guided for positive year-end cash flow despite a significant investments to build inventories and continue clinical development initiatives.
CRXL offers robust fundamentals as a pure-play on preventive medicine in the form of vaccines and a valuable technology platform for the production of therapeutic proteins and monoclonal antibodies. For these reasons and the previous Wyeth bid, CRXL is poised to be acquired some time this year by one of its larger rivals outlined earlier as part of widespread M&A this year in the healthcare sector.
Wednesday, January 28, 2009
Updated Clinical Trial and FDA Calendars
The tables at my website link below feature an updated calendar of 78 expected FDA new product decisions and 92 pending clinical trial result estimates + pending FDA re-submissions or new submissions for regulatory approval. Click here for a link to my previous calendars and below is a summary of FDA and clinical trial news since my last article.
http://www.etfinnovators.com/2009/01/updated-clinical-trial-and-fda-calendar.html
1.) Watson Pharma (WPI): WPI received FDA approval for Gelnique, which represents the first and only topical gel to treat overactive bladder. Gelnique contains the active ingredient (oxybutynin) which is already used in oral tablet (Ditropan) and skin patch (Oxytrol) formulations. Watson's gel formulation is designed to bypass liver metabolism and reduce side effects such as dry mouth, GI difficulties, and drowsiness.
2.) Savient Pharma (SVNT): SVNT announced that the pending priority review BLA for Puricase (pegloticase) with a 4/30/09 PDUFA date for treatment-failure gout will be reviewed by and FDA Advisory Panel (Arthritis Committee) on 3/5/09, which is a requirement for compounds that represent a new therapeutic class. The advisory panel will likely be focused on safety issues (cardiovascular) since Puricase has been proven effective in clinical trials.
3.) ARCA biopharma (ABIO): ABIO began trading today on the Nasdaq, with a pending PDUFA date of 5/31/09 for Gencaro (bucindolol) for the treatment of chronic heart failure. ARCA also has a collaboration with LabCorp (LH) and a pending PMA for a genetic test which is designed to be used in conjunction with Gencaro. ARCA has identified genetic traits which the Company believes will predict patient responses to the drug and hopes to launch both as a personalized medicine combination to optimize treatment outcomes.
4.) Theravance (THRX): THRX submitted a NDA for Telavancin as a once-daily injectable antibiotic for the treatment of hospital-acquired pneumonia (HAP), including bacterial strains such as methicillin-resistant Staph aureus (MRSA). A 10-month standard review for the NDA results in a PDUFA date of 11/26/09.
http://www.etfinnovators.com/2009/01/updated-clinical-trial-and-fda-calendar.html
1.) Watson Pharma (WPI): WPI received FDA approval for Gelnique, which represents the first and only topical gel to treat overactive bladder. Gelnique contains the active ingredient (oxybutynin) which is already used in oral tablet (Ditropan) and skin patch (Oxytrol) formulations. Watson's gel formulation is designed to bypass liver metabolism and reduce side effects such as dry mouth, GI difficulties, and drowsiness.
2.) Savient Pharma (SVNT): SVNT announced that the pending priority review BLA for Puricase (pegloticase) with a 4/30/09 PDUFA date for treatment-failure gout will be reviewed by and FDA Advisory Panel (Arthritis Committee) on 3/5/09, which is a requirement for compounds that represent a new therapeutic class. The advisory panel will likely be focused on safety issues (cardiovascular) since Puricase has been proven effective in clinical trials.
3.) ARCA biopharma (ABIO): ABIO began trading today on the Nasdaq, with a pending PDUFA date of 5/31/09 for Gencaro (bucindolol) for the treatment of chronic heart failure. ARCA also has a collaboration with LabCorp (LH) and a pending PMA for a genetic test which is designed to be used in conjunction with Gencaro. ARCA has identified genetic traits which the Company believes will predict patient responses to the drug and hopes to launch both as a personalized medicine combination to optimize treatment outcomes.
4.) Theravance (THRX): THRX submitted a NDA for Telavancin as a once-daily injectable antibiotic for the treatment of hospital-acquired pneumonia (HAP), including bacterial strains such as methicillin-resistant Staph aureus (MRSA). A 10-month standard review for the NDA results in a PDUFA date of 11/26/09.
Hi-Tech Pharmacal: Hi-Growth at a Value Price
With shares of Home Diagnostics (HDIX) surging by nearly 50% since I profiled the company in mid-December as a turnaround, value play from the ETF Innovators Healthcare Cost Containment Index; a search for compelling values among these companies today led me to generic drug maker Hi-Tech Pharmacal (HITK).
Shares of HITK are down by about 10% in the past five days on light volume and no news headlines, providing a nice chance to accumulate some shares. The Company reported record quarterly revenue for its second fiscal quarter and is expected to earn 41 cents per share for FY09 (which ends in April), which results in a P/E of about 11 based on the current price around $4.60 per share.
http://www.etfinnovators.com/2009/01/hi-tech-pharmacal-hi-growth-at-value.html
As illustrated in the accompanying one-month chart, HITK has lagged behind its peer group – including a gain of about 10% for Caraco Pharma (CPD) and over 20% for Mylan Labs (MYL). Also, favorable trends for the generic drug industry include $70B in patent expirations through 2012, a push to increase generic substitution rates to 70% from 65%, and legislation expected this year to clear the way for generic versions of high-cost biotech drugs.
Despite the favorable growth outlook for generic drug makers such as HITK in the coming years, the stock trades at deep value parameters, trading at just two-thirds of its book value and trailing 12-month revenue. HITK holds $12.9M in cash with negligible long-term debt of $0.3M for an enterprise value (EV) of $38M, yielding an EV to revenue ratio of 0.5X. Trailing 12-month revenue is $77M and the current market cap is $52M.
As with HDIX, HITK also believes its stock represents an excellent value, repurchasing a total of 94,000 shares of common stock during its last fiscal quarter ending in October for a total cost of $661,000 for an average price of about $7 per share. Investors today can buy shares of HITK at a steep discount of about 33% with shares hovering around the $4.60 level.
For the 2Q09, HITK posted a 44% increase from the year-ago period for generic drug product sales at $19.5M, boosted by $5.4M in sales of Dorzolamide with Timolol ophthalmic solution as the generic equivalent for Merck's (MRK) Cosopt for the treatment of glaucoma. HITK also posted strong results for its consumer healthcare division, which also increased by 44% to $3.3M, thanks to newly launched brands which include Zostrix Neuropathy and Nasal Ease.
As expected with a multitude of new product launches during 2Q09, HITK experienced increases across the board from the year-ago period for the following:
- cost of sales (up 28.4% to $13.1M, but down 12% as a percentage of sales to 52%)
- research and product development (R&D) (up 20% to $1.8M)
- selling, general, and administrative (SG&A) (up 31.6% to $7.5M)
The sharp increase in sales and higher margins for new products resulted in net income for the quarter of $1.1M, reversing a $1M loss in the year-ago period for diluted EPS of $0.09 versus a loss of ($0.08) last year.
The ongoing saga and recently extended $7.75 per share tender offer (until 1/30/09) for Taro Pharma (TAROF) by India's largest generic drug maker by market cap, Sun Pharma (524715), offers a relative valuation comparison for a small-cap generic drug company. The $7.75 per share tender offer values Taro at about 0.9X sales or $283M; although the Company is currently trading almost $2 above the tender offer price at $9.55 per share.
HITK enjoys a stronger balance sheet than Taro, with the latter holding $66M in cash and net debt of $123M, which makes the actual purchase price for Sun Pharma even higher at an EV of about $400M and an EV to revenue ratio of 1.3X. On a relative valuation basis, HITK has about 2X upside from current levels to nine bucks, which would result in a similar EV to revenue ratio. Also, CPD would yield similar upside potential on a relative valuation basis and I own both of these stocks as my favorite value plays in the generic drug industry.
Shares of HITK are down by about 10% in the past five days on light volume and no news headlines, providing a nice chance to accumulate some shares. The Company reported record quarterly revenue for its second fiscal quarter and is expected to earn 41 cents per share for FY09 (which ends in April), which results in a P/E of about 11 based on the current price around $4.60 per share.
http://www.etfinnovators.com/2009/01/hi-tech-pharmacal-hi-growth-at-value.html
As illustrated in the accompanying one-month chart, HITK has lagged behind its peer group – including a gain of about 10% for Caraco Pharma (CPD) and over 20% for Mylan Labs (MYL). Also, favorable trends for the generic drug industry include $70B in patent expirations through 2012, a push to increase generic substitution rates to 70% from 65%, and legislation expected this year to clear the way for generic versions of high-cost biotech drugs.
Despite the favorable growth outlook for generic drug makers such as HITK in the coming years, the stock trades at deep value parameters, trading at just two-thirds of its book value and trailing 12-month revenue. HITK holds $12.9M in cash with negligible long-term debt of $0.3M for an enterprise value (EV) of $38M, yielding an EV to revenue ratio of 0.5X. Trailing 12-month revenue is $77M and the current market cap is $52M.
As with HDIX, HITK also believes its stock represents an excellent value, repurchasing a total of 94,000 shares of common stock during its last fiscal quarter ending in October for a total cost of $661,000 for an average price of about $7 per share. Investors today can buy shares of HITK at a steep discount of about 33% with shares hovering around the $4.60 level.
For the 2Q09, HITK posted a 44% increase from the year-ago period for generic drug product sales at $19.5M, boosted by $5.4M in sales of Dorzolamide with Timolol ophthalmic solution as the generic equivalent for Merck's (MRK) Cosopt for the treatment of glaucoma. HITK also posted strong results for its consumer healthcare division, which also increased by 44% to $3.3M, thanks to newly launched brands which include Zostrix Neuropathy and Nasal Ease.
As expected with a multitude of new product launches during 2Q09, HITK experienced increases across the board from the year-ago period for the following:
- cost of sales (up 28.4% to $13.1M, but down 12% as a percentage of sales to 52%)
- research and product development (R&D) (up 20% to $1.8M)
- selling, general, and administrative (SG&A) (up 31.6% to $7.5M)
The sharp increase in sales and higher margins for new products resulted in net income for the quarter of $1.1M, reversing a $1M loss in the year-ago period for diluted EPS of $0.09 versus a loss of ($0.08) last year.
The ongoing saga and recently extended $7.75 per share tender offer (until 1/30/09) for Taro Pharma (TAROF) by India's largest generic drug maker by market cap, Sun Pharma (524715), offers a relative valuation comparison for a small-cap generic drug company. The $7.75 per share tender offer values Taro at about 0.9X sales or $283M; although the Company is currently trading almost $2 above the tender offer price at $9.55 per share.
HITK enjoys a stronger balance sheet than Taro, with the latter holding $66M in cash and net debt of $123M, which makes the actual purchase price for Sun Pharma even higher at an EV of about $400M and an EV to revenue ratio of 1.3X. On a relative valuation basis, HITK has about 2X upside from current levels to nine bucks, which would result in a similar EV to revenue ratio. Also, CPD would yield similar upside potential on a relative valuation basis and I own both of these stocks as my favorite value plays in the generic drug industry.
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