Company Product / Description / Indication Status (Date) Abraxis BioScience Inc. Abraxane; Paclitaxel protein-bound particles for injection; albumin-bound for late-stage non-small-cell lung cancer Phase II data showed improved antitumor benefits over the solvent-based taxane treatment; 50% of patients had either a complete or partial response (ASCO) Active Biotech AB Anyara; Antibody linked to a toxin designed to stimulate immune system to target and kill cancer cells for advanced non
Company Product / Description / Indication Status (Date) Acorda Therapeutics Inc. Fampridine-SR; Selective neuronal potassium channel blocker for multiple sclerosis Phase III trial run under FDA SPA demonstrated statistical significance on all three efficacy criteria, which related to walking capabilities (9/25/06) Biogen Idec Inc. BG-12; Oral fumarate derivative with an immunomodulatory mechanism of action for multiple sclerosis Company launched a Phase III program (1/9/07) Biogen
Company Product / Description / Indication Status (Date) Actelion Ltd. Actelion-1; Endothelin receptor antagonist for pulmonary hypertension The molecule is moving into a Phase III program following Phase II data (12/13/06) Tracleer; Oral dual endothelin receptor antagonist; bosentan for PAH Began trials in patients with PAH secondary to sickle cell disease to evaluate various efficacy endpoints (4/10/06) BioMarin Pharmaceutical Inc. 6R-BH4; Tetrahydrobiopterin; Enzyme cofactor that
Company Product / Description / Indication Status (Date) Advanced Life Sciences Inc. Calanolide A for HIV and TB In Phase I clinicals AlphaVax Inc. AVX101; Vaccine incorporating the HIV Gag gene for the prevention of HIV infection Preliminary Phase I data showed antibody responses to the HIV Gag antigen in all those receiving the highest dose; vaccine was safe and well tolerated (9/6/06) Ambrilia Biopharma Inc. PPL-100; HIV protease inhibitor Phase I trial demonstrated safety
Company Product / Description / Indication Status (Date) Amicus Therapeutics Inc. AT2101 for Gaucher’s disease In Phase I clinicals Genzyme Corp. Genz-112638; Oral, ceramide analogue; designed to inhibit the enzyme glucosylceramide synthase for Gaucher’s disease Began open-label Phase II trial that will evaluate patient responses (7/26/06) Protalix BioTherapeutics Ltd. Recombinant human protein for the treatment of Gaucher’s disease To begin clinicals Shire plc GA-GCB for
Company Product / Description / Indication Status (Date) Advanced Viral Research Corp. AVR118; Peptide-nucleic acid complex with immuno-modulatory properties for Type II diabetes Interim Phase I data demonstrated safety; no effects were seen on blood glucose levels in those receiving oral hypoglycemic therapies (8/10/06) Alantos Pharmaceuticals Holdings Inc. ALS 2-0426; Small-molecule inhibitor of dipeptidyl peptidase IV for Type II diabetes Began Phase I trial to evaluate safety
Company Product / Description / Indication Status (Date) Biogen Idec Inc. and Elan Corp. plc Tysabri; Natalizumab; humanized monoclonal antibody that inhibits adhesion molecules on immune cells Data showed drug maintained remission for longer than two years (10/24/06) Cambridge Antibody Technology Group plc (with Abbott Laboratories) Humira In Phase III clinicals ChemoCentryx Inc. Traficet-EN (CCX282-B); Oral anti-inflammatory agent that targets the CCR9 chemokine receptor Phase II
Company Product / Description / Indication Status (Date) Abraxis BioScience Inc. Abraxane; Paclitaxel protein-bound particles for injection; albumin-bound for metastatic breast cancer Phase II data of Abraxane vs. Taxotere in first-line treatment showed that weekly Abraxane increased tumor response rate by greater than 60% with less toxicity vs. Taxotere given every three weeks (12/18/06) Adventrx Pharmaceuticals Inc. CoFactor (ANX-510); A folate-based biomodulator drug designed to
Company Product / Description / Indication Status (Date) Amgen Inc. Denosumab for rheumatoid arthritis In Phase II clinicals Androclus Therapeutics Inc. AT-001 (dnaJP1) for rheumatoid arthritis Completed Phase II Angiotech Pharmaceuticals Inc. Paxceed for rheumatoid arthritis In clinicals Arakis Ltd. AD 452 for rheumatoid arthritis In Phase IIb clinicals AstraZeneca plc AZD9056 for rheumatoid arthritis In Phase II clinicals AZD8309 for rheumatoid arthritis In Phase I
Company Product / Description / Indication Status (Date) Advanced Magnetics Inc. Ferumoxytol; Intravenously administered bioavailable iron for iron replacement in anemic chronic kidney disease Monitors reviewing safety data from Phase III trial recommended the study continue (2/21/06); Monitors in Phase III trial identified no safety concerns and recommended continuation without modification (6/14/06); Monitors found no safety concerns in review of data from 1,200 patients in Phase III
Company Product Marketer (at time of approval) Indication (U.S. Approval Date, Month/Year) 1982 Genentech Inc. Humulin Eli Lilly and Co. Diabetes (10/82) 1985 Genentech Inc. Protropin Genentech Inc. Growth hormone inadequacy; growth failure associated with chronic renal insufficiency in children (10/85) 1986 Biogen Inc.* Intron-A Schering-Plough Corp. Hairy cell leukemia (6/86); genital warts (6/88); AIDS-related Kaposi's sarcoma (11/88); hepatitis C (2/91); hepatitis B (7/92
What everyone knows by now Biotech is on top. All market indicators point upward. Everyone wants in. What you may not know The biotechnology industry, on the strength of its drugs, continues to surpass the pharmaceutical industry for the third straight year as the leading source of new therapeutics, and the percentage of industry growth is double that of the larger pharmaceutical market. Owing to its products on the market and the candidates flourishing in many late-stage clinical trials
Amir Elstein is the group vice president, global specialty pharmaceutical products of Teva Pharmaceutical Industries Ltd. He served as the company’s group vice president of biogenerics from January 2005 to January 2006 and as a director from 1995 to 2004. Elstein received a BSc in physics and mathematics, an MSc in the Solid State Physics Department of Applied Physics, and a diploma of senior business management from the Hebrew University. The following interview was conducted on March 20, 2007
Dr. William Sheridan is vice president of European medical affairs at Amgen Europe. He previously worked at the company’s California headquarters in drug development and commercialization. He completed his initial training at the University of Melbourne, Australia, and had a research fellowship at the Division of Hematology and Medical Oncology at Emory University School of Medicine, Atlanta. The following interview was conducted on March 6, 2007. Is Amgen taking competition from biogenerics
Proper name: Montelukast sodium Drug Developer: Merck & Co. Inc. Location: Whitehouse Station, N.J. Website: www.merck.com Indication(s): Asthma and allergies Approval date: 1998 2006 Revenue: $3.6 billion Percentage of Merck’s Total Revenue: 15.9 percent Merck & Co. Inc.’s Singulair is approved to help control asthma in adults and children as young as 12 months and to help relieve the symptoms of indoor and outdoor allergies. Leukotriene inhibitors such as Singulair block a single
Proper name: Venlafaxine Drug Developer: Wyeth Location: Madison, N.J. Website: www.wyeth.com Indication(s): Depression, generalized anxiety disorder and social anxiety disorder Approval date: 1993 2006 Revenue: $3.722 billion Percentage of Wyeth’s Total Revenue: 18.29 percent Combined with Effexor XR, Effexor is the world’s top antidepressant franchise. 2006 sales increased 8 percent over the previous year, up $222 million. The drug is indicated for the treatment of major depressive
Proper name: Risperidone Drug Developer: Janssen Pharmaceutica Products Location: Titusville, N.J. Website: www.janssen.com Indication(s): Bipolar mania and schizophrenia Approval date: 1993 2006 Revenue: $4.183 billion Percentage of Johnson & Johnson’s Total Revenue: 7.84 percent Janssen Pharmaceutica Products’ Risperdal, approved in 1993, is indicated for bipolar mania and schizophrenia. The company also markets Risperdal Consta for schizophrenia. The patent for Risperdal will expire
(in billions of U.S. dollars) Year Pharmaceutical Biotechnology Total 2003 467.1 41.7 508.8 2004 523.6 49.9 573.5 2005 592.7 58.1 650.8 2006 671.5 70.1 741.6 2007* 694.1 81.4 775.5 2008* 737.6 89.1 826.7 2009* 771.3 98.7 870.0 2010* 838.3 104.2 942.5 SOURCE: BioWorld