BioPharma Review

 

Curis (CRIS)

Curis, Inc. is a drug discovery and development company committed to leveraging signaling pathway drug technologies in seeking to create new medicines, primarily for cancer. The Company’s product development approach consists of generating small molecules to target one or more of the components of such abnormally regulated signaling pathway network to provide therapeutic effect. Product candidates include GDC-0449, small molecule and antibody under the Hedgehog systemic antagonist program; CUDC-101 and others under the targeted cancer development platform, and Hedgehog protein agonist under other research programs.


Poniard (PARD)

Poniard Pharmaceuticals Inc. (Poniard) is a biopharmaceutical company focused on the development and commercialization of cancer therapy products. Its lead product candidate is picoplatin, a new generation platinum-based cancer therapy with an improved safety profile. An intravenous chemotherapeutic agent, picoplatin is designed to overcome platinum resistance in the treatment of solid tumors. Based on positive interim median overall survival data from the ongoing Phase II study, the Company initiated a Phase III SPEAR (Study of Picoplatin Efficacy After Relapse) trial of picoplatin in small cell lung cancer. The Company is also conducting separate Phase I/II studies of picoplatin in the treatment of patients with metastatic colorectal cancer and hormone-refractory prostate cancer. NeoRx Manufacturing Group, Inc. is a wholly owned subsidiary of the Company.


Halozyme (HALO)

Halozyme Therapeutics, Inc. (Halozyme) is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix (Matrix) for the drug delivery, oncology, and dermatology markets. Its portfolio of products is based on the property covering the family of human enzymes known as hyaluronidases. Halozyme has two United States Food and Drug Administration (FDA)-approved products, Cumulase, a product used for in vitro fertilization (IVF), and Hylenex, an agent for drug and fluid infusion.

Osiris (OSIR)

Osiris Therapeutics, Inc. (Osiris) is a stem cell therapeutic company focused on developing and marketing products to treat medical conditions in the inflammatory, orthopedic and cardiovascular areas. The Company markets and sells Osteocel for regenerating bone in orthopedic indications. It contains viable stem cells. The Company’s biologic drug candidate, Prochymal, for the treatment of inflammatory disease, is a stem cell therapeutic, for which patients are being enrolled in Phase III clinical trials. It is designated by the United States Food and Drug Administration (FDA) as both an Orphan Drug and Fast Track product candidate. The Company’s pipeline of internally developed biologic drug candidates also includes Chondrogen, for regenerating cartilage in the knee, and Provacel, for repairing heart tissue following a heart attack.


Cougar Biotechnology (CGRB)

Cougar Biotechnology, Inc. is a development-stage biopharmaceutical company that acquires and develops products for the treatment of cancer. The Company focuses on in-licensing drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer, and then developing those drug candidates for commercial use. It has rights to three clinical stage drug candidates: CB7630 (Abiraterone Acetate), CB3304 (Noscapine and related analogs) and CB1089 (Seocalcitol). It is also conducting pre-clinical development of CB6604, an extended release version of CB3304.


Regeneron (REGN)

Regeneron Pharmaceuticals, Inc. (Regeneron) is a biopharmaceutical company that discovers, develops, and intends to commercialize pharmaceutical products for the treatment of serious medical conditions. The Company has four clinical development programs, including three late-stage clinical programs: ARCALYST (rilonacept, also known as IL-1Trap) in various inflammatory indications, aflibercept (VEGF Trap) in oncology and the VEGF Trap-Eye formulation in eye diseases using intraocular delivery. Aflibercept is being developed in oncology in collaboration with the sanofi-aventis Group. The VEGF Trap-Eye is being developed in collaboration with Bayer HealthCare LLC. The Company’s fourth clinical development program is REGN88, an antibody to the Interleukin-6 receptor (IL-6R) that is being developed with sanofi-aventis. REGN88 entered clinical development in patients with rheumatoid arthritis during the year ended December 31, 2007.


Alnylam (ALNY)

Alnylam Pharmaceuticals, Inc. is a biopharmaceutical company developing therapeutics based on ribonucleic acid interference (RNAi). RNAi is a naturally occurring biological pathway within cells for selectively silencing and regulating the expression of specific genes. The Company’s lead RNAi therapeutic program, ALN-RSV01, is for the treatment of human respiratory syncytial virus (RSV) infection. The Company has three RNAi therapeutic programs in pre-clinical development, ALN-PCS, ALN-VSP and ALN-HTT, focused on the treatment of hypercholesterolemia, liver cancer and Huntington’s disease (HD), respectively. Alnylam Pharmaceuticals has additional discovery programs for RNAi therapeutics for the treatment of a range of diseases.


Mannkind (MNKD)

MannKind Corporation (MannKind) is a biopharmaceutical company focused on the discovery, development and commercialization of therapeutic products for diseases, such as diabetes and cancer. As of December 31, 2007, the Company's lead investigational product candidate, the Technosphere Insulin System, was in Phase III clinical trials in the United States, Europe and Latin America to study its safety and efficacy in the treatment of diabetes. This dry powder therapy consists of the Company’s Technosphere particles, onto which insulin molecules are loaded. These loaded particles are then aerosolized and inhaled into the deep lung using MannKind’s MedTone inhaler.


Amicus (FOLD)

Amicus Therapeutics, Inc. (Amicus) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of orally administered, small molecule drugs, known as pharmacological chaperones, for the treatment of a range of human genetic diseases. Its approach to the treatment of human genetic diseases consists of using pharmacological chaperones that selectively bind to the target protein, increasing the stability of the protein and helping it fold into the correct three-dimensional shape. The Company’s lead products in development are Amigal for Fabry disease, Plicera for Gaucher disease and AT2220 for Pompe disease. The standard of treatment for Fabry, Gaucher and Pompe is enzyme replacement therapy. In November 2007, the Company entered into a collaboration with Shire Pharmaceuticals Ireland Ltd. (Shire), to jointly develop its three lead pharmacological chaperone compounds for lysosomal storage disorders.


CombinatoRx (CRXX)

CombinatoRx, Incorporated is a biopharmaceutical company focused on developing synergistic combinations pharmaceuticals, with a portfolio of product candidates in phase II clinical development. The Company creates product candidates with mechanisms of action striking at the biological complexities of human disease. The principal programs in its portfolio are advancing into later stage clinical trials. This portfolio is internally generated from CombinatoRx, Incorporated’s combination high throughput screening (cHTS) technology, which provides a renewable and previously untapped source of drug candidates. The Company is developing a clinical portfolio of product candidates targeting multiple diseases, including immuno-inflammatory diseases, topical dermatoses and metabolic disease.


Vical (VICL)

Vical Incorporated researches and develops biopharmaceutical products based on its DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. The Company has three active independent development programs in the areas of infectious disease and cancer. These are a Phase III clinical trial using its Allovectin-7 immunotherapeutic in patients with metastatic melanoma; a Phase II clinical trial using its cytomegalovirus (CMV) DNA vaccine in hematopoietic cell transplant patients, and a Phase I clinical trial using its pandemic influenza DNA vaccine formulated with its Vaxfectin adjuvant. The Company has licensing and collaboration arrangements, such as its licensing arrangements with Merck & Co., Inc. (Merck), the sanofi-aventis Group (sanofi-aventis), Aqua Health Ltd. of Canada, an affiliate of Novartis Animal Health, Merial Limited, a joint venture of Merck and sanofi-aventis and AnGes, among other research-driven biopharmaceutical companies.


Hollis-Eden (HEPH)

Hollis-Eden Pharmaceuticals, Inc. (Hollis-Eden) is a development-stage pharmaceutical company. The Company is focused on the development of a class of adrenal steroid hormones as pharmaceuticals for human health. Through its Hormonal Signaling Technology Platform, Hollis-Eden is developing a series of small molecule compounds that are metabolites or synthetic analogs of endogenous hormones derived by the adrenal glands from the body’s most abundant circulating steroid. The Company’s clinical drug development candidates include TRIOLEX (HE3286), a next-generation compound that is in a clinical trial for the treatment of type 2 diabetes. TRIOLEX (HE3286) is being cleared by the United States Food and Drug Administration (FDA) for clinical trials in rheumatoid arthritis. A second next-generation candidate, APOPTONE (HE3235), has been selected for clinical development in cancer.


Cyclacel (CYCC)

Cyclacel Pharmaceuticals, Inc. (Cyclacel), incorporated in 1996, is a development-stage biopharmaceutical company engaged in the discovery, development and commercialization of mechanism-targeted drugs to treat human cancers and other serious disorders. The Company markets, directly in the United States, Xclair Cream for radiation dermatitis and Numoisyn Liquid and Numoisyn Lozenges for xerostomia through its wholly owned subsidiary, ALIGN Pharmaceuticals, LLC (ALIGN). All three products were launched in the United States in January 2006. Through ALIGN, the Company acquired Achilles Acquisition, LLC on October 5, 2007

Private Companies


Tolerx


Chemocentryx


Elixir Pharmaceuticals


Ambrx


QuatRx

 

 

 
 
 
   
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