Biotech success, 2002 Message Board

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Biotech / Medical : Biotech success, 2002

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To: Miljenko Zuanic who started this subject	2/5/2002 4:45:53 PM
From: michael_f_murphy	Read Replies (1) of 117

retrospective - FDA Approvals, 2001 bio.org New Products* Product Company Indication Approval date Aranesp™ (darbepoetin alfa;recombinant erythropoiesis-stimulating protein) Amgen Anemia associated with chronic liver failure September Campath® (alemtuzumab; recombinant monoclonal antibody against CD52 glycoprotein) Ilex Oncology Inc., Millennium Pharmceuticals Inc. and Berlex Laboratories Inc. B-cell chronic lymphocytic leukemia in patients who have been treated with alkylating agents and who have failed fludarabine therapy May Dermagraft® (human-based, tissue-engineered living dermal substitute) Advanced Tissue Sciences Inc. and Smith & Nephew plc Diabetic foot ulcers September DigiFab™ (digoxin immune fab [ovine]) Protherics plc Digoxin toxicity September Focalin™ (dexmethylphenidate hydrochloride; refined version of methylphenidate containing only the active isomer) Celgene Corp. and Novartis Pharmaceuticals Corp. Attention deficit hyperactivity disorder November Frova™ (frovatriptan succinate) Vernalis Group plc and Elan Corp. plc Migraine November Gleevec™ (imatinib mesylate) Novartis Pharmaceuticals Corp Chronic myeloid leukemia in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy May Kineret™ (anakinra; recombinant form of non-glycosylated human interleukin-1 receptor antagonist) Amgen Moderately to severely active rheumatoid arthritis in adult patients who have failed disease-modifying anti-rheumatic drugs November Metadate® CD (bi-phasic release formulation of methylphenidate) Celltech Pharmaceuticals Inc. Attention deficit hyperactivity disorder April Natrecor® (nesiritide; recombinant form of human B-type natriuretic peptide) Scios Inc. Acutely decompensated congestive heart failure with shortness of breath at rest or with minimal activity August OrCel™ (composite cultured skin; bi-layered cellular matrix) Ortec International Inc. For patients with recessive dystrophic epidemolysis bullosa undergoing hand reconstruction surgery February PEG-Intron™ (pegylated version of recombinant interfreron alfa-2b) Enzon Inc. and Schering-Plough Corp. Monotherapy for chronic hepatitis C January Tracleer™ (bosentan) Actelion Ltd. Pulmonary arterial hypertension with WHO Class III or IV symptoms November Twinrix® (hepatitis A inactivated and hepatitis B [recombinant] vaccine) SmithKline Beecham Biologicals (unit of GlaxoSmith-Kline) Immunization against hepatitis A and B viruses May Viread™ (tenofovir disoproxil fumarate) Gilead Sciences For use in combination with other antiretroviral agents for treatment of HIV-1 infection October Xigris™ (drotrecogin alfa activated; recombinant form of human Activated Protein C) Eli Lilly and Co. Severe, life-threatening sepsis November New Indications for Previously Approved Products* Product Company Indication Approval date Cathflo™ Activase® (alteplase; recombinant tissue plasminogen activator) Genentech Inc. Dissolution of clots in central venous access devices September GenoTropin® (recombinant form of human somatropin) Pharmacia Long-term treatment of growth failure in children born small for gestational age who fail to catch up by age 2 July Integrilin® (eptifibatide) COR Therapeutics Inc. Acute coronary syndrome, including both patients managed medically and those undergoing percutaneous coronary intervention June NovoLog® (insulin aspart; recombinant) Novo Nordisk For pump therapy in diabetes December OrCel™ (composite cultured skin; bi-layered cellular matrix) Ortec International Inc. Treatment of donor site wounds in burn victims August PEG-Intron™ (pegylated version of recombinant interferon alfa-2b) Enzon Inc. and Schering-Plough Combination therapy with Rebetol for treatment of hepatitis C in patients with compensated liver disease August Simulect® (basiliximab; recombinant monoclonal antibody that binds the interleukin-2 receptor-alpha chain) Novartis Pharmaceutical Corp. Prevention of rejection in combination with triple immunosuppressive therapy in renal transplant; use in pediatric renal transplant; and use of IV bolus injection March Visudyne™ (verteporfin for injection) QLT PhotoTherapeutics Inc. and Novartis Ophthalmics Predominantly classic subfoveal choroidal neovascularization due to pathologic myopia (severe near-sightedness) August * Note: This list includes novel biologics developed by biotechnology companies and pharmaceutical companies, as well as small-molecule products developed by biotechnology companies, and other selected small-molecule or tissue-engineered products. For a complete listing of 2001 FDA approvals, visit the agency's Web site at www.fda.gov.

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