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Biotech / Medical : Biotech News -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (2839)	1/6/2004 4:17:04 AM
From: Icebrg	Read Replies (1) \| Respond to of 7143

Biotechnology Industry Posts 37 FDA Approvals, $16.4 Billion in Financing in 2003 WASHINGTON, Jan. 5 /PRNewswire/ -- The biotechnology industry enters 2004 stronger than ever after earning 37 FDA approvals, raising $16.4 billion in new financing and winning significant battles on Capitol Hill in 2003. "Biotechnology is a performance-driven industry," said BIO President Carl B. Feldbaum. "In 2003, the biotechnology's results at the FDA were terrific, driving an industry recovery on Wall Street and further boosting the industry's political credibility." The FDA approved 25 new biotechnology drugs and biologics in 2003, up 25 percent from 2002. The new approvals include first-in-class medicines for genetic disorders, HIV/AIDS, Alzheimer's disease, psoriasis, asthma and cancer. The agency also cleared 12 new indications for previously approved biotech products. "The results that matter most in this industry are the ones that benefit patients, and the biotech products approved this past year will help many whose needs would otherwise be unmet," said Feldbaum. "The upswing in approvals in part reflects new energy at the FDA under the leadership of Commissioner Mark McClellan, who brought a deep commitment to innovation and sensible risk-benefit analysis to the agency in 2003." FDA approvals, combined with stellar earnings performances at companies with marketed products, drove the Nasdaq biotech index up 46 percent in 2003 and helped biotech companies to raise $16.4 billion in new financing, up 56 percent from 2002. "It's not just the industry's established companies that have done well," noted Feldbaum. "Small-cap stock gains outpaced those of the industry's top tier, and venture capitalists poured $3.3 billion into privately held biotechs. In fact, the life sciences eclipsed software in the third quarter to become the number one destination for venture capital funding." Industry Advances Political Agenda: * BIO's pro-innovation principles were incorporated into the Medicare drug coverage law, which also reversed deep cuts in biotech products that were already covered under the program. * Bills to allow biotechnology companies to take advantage of net operating losses were introduced in both the House and Senate. * The comprehensive energy legislation that passed the House and is now pending in the Senate includes more than $800 million in bioenergy incentives and sets mandatory requirements for usage of biofuels. * Efforts to ban therapeutic applications of cloning technology were defeated in Congress, at the United Nations, and in several states. * The international food safety organization Codex Alimentarius approved science-based risk-assessment rules for foods derived from biotechnology. In 2004, BIO's legislative priorities include passage of tax reform and energy legislation, as well as Project BioShield, the Patent and Trademark Office fee bill and small business legislation that would ensure venture-backed biotech firms qualify for Small Business Innovation Research grants. BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 33 other nations. BIO members are involved in the research and development of health-care, agricultural, industrial and environmental biotechnology products. Note: A list of biotech drug approvals follows. 2003 Biotech Drug Approvals Note: Recombinant proteins and monoclonal antibodies are underlined. This list includes monoclonal antibodies and recombinant proteins 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 considered relevant to the biotechnology industry. New Products Product Description Company Indication ADVATE Recombinant Baxter Hemophilia A ------ antihemophilic Healthcare factor produced Corp. without any added human or animal plasma proteins and albumin ALDURAZYME(R) Laronidase; BioMarin Mucopolysac- ------------ recombinant Pharmaceuticals charidosis-1 enzyme Inc. and replacement Genzyme Aloxi Palonosetron HCl MGI Pharma and Prevention of injection; 5-HT3 Helsinn acute nausea and receptor antagonist Healthcare vomiting in chemotherapy patients AMEVIVE(R) Alefacept; Biogen Moderate to severe --------- recombinant, chronic plaque dimeric fusion psoriasis protein; targets CD45RO+ T-cells BEXXAR(R) Tositumomab Corixa Corp. CD20-positive, --------- and I-131 and follicular non- tositumomab; GlaxoSmithKline Hodgkin's lym- monoclonal phoma whose antibody disease is targeting the refractory CD20 antigen to Rituxan and and radiolabeled has relapsed version of the following antibody chemotherapy Cialis(R) Tadalafil; Lilly ICOS LLC Erectile oral PD55 (joint venture dysfunction inhibitor of Eli Lilly and Co. and ICOS Corp.) CosmoDerm(TM)/ Dermal fillers Advanced Wrinkle CosmoPlast(TM) containing human- Tissue injections based collagen Sciences Inc. and Inamed Corp. Cubicin(TM) Daptomycin Cubist Bacterial for injection Pharmaceut- infections icals Inc. and Chiron Corp. Elestat(TM) Epinastine HCl Inspire Persistent itching ophthalmic Pharmaceu- associated with solution ticals Inc., allergic 0.05% Inc. Allergan Inc conjunctivitis (Inspire signed a co-promotion agreement following approval of the Allergan drug) and Boehringer Ingelheim Emtriva(TM) Emtricitabine; Gilead Treatment of HIV once-daily Sciences Inc. infection in adults nucleoside as part of reverse combination transcriptase inhibitor (capsule) ESTRASORB(TM) Estradiol topical Novavax Inc. Short-term use emulsion and King to reduce Pharmaceuticals moderate to Inc. severe vasomotor symptoms ("hot flashes") in menopausal women Fabrazyme(R) Algasidase beta; Genzyme Fabry's disease ----------- recombinant enzyme replacement FACTIVE(R) Gemifloxacin GeneSoft Mild to moderate mesylate Pharmaceu- community-acquired ticals Inc. pneumonia and acute bacterial exacerba- tion of chronic bronchitis FluMist(TM) Nasally delivered MedImmune Inc. Prevention of flu influenza vaccine FUZEON(TM) Enfuvirtide; Trimeris Inc. Component of fusion inhibitor and Roche combination (subcutaneous therapy for HIV-1 injection) infection in treatment- experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy Ganite(TM) Gallium nitrate Genta Inc. Cancer-related injection hypercalcemia Lexiva(TM) Fosamprenavir Vertex Treatment of HIV calcium; protease Pharmaceuticals infection in adults inhibitor (tablet) and in combination with GlaxoSmithKline other antiretrovirals NAMENDA(TM) Memantine HCl; Neurobiological Mild to moderate N-methyl-D- Technologies Alzheimer's aspartate receptor Inc. and Forest antagonist (tablet) Laboratories Plenaxis(TM) Abarelix Praecis Palliative (injectable Pharmaceuticals treatment of suspension); Inc. men with advanced gonadotropin symptomatic releasing hormone prostate cancer antagonist under certain conditions RAPTIVA(TM) Efalizumab; Xoma Ltd. and Chronic moderate ----------- selective, Genentech Inc. to severe plaque reversible psoriasis in adults T-cell blocker (subcutaneous injection; self- administered) RISPERDAL(R) Risperidone, Alkermes Inc. Schizophrenia CONSTA(TM) long-acting and injection Johnson & formulation; Johnson uses Medisorb(R) drug delivery technology that encapsulates active medication in slow- degrading, polymer- based microspheres SOMAVERT(R) Pegvisomant; Nektar Acromegaly ----------- pegylated version Therapeutics of a recombinant and Pfizer Inc. human growth hormone analog structurally altered to act as a GH receptor antagonist VELCADE(TM) Bortezomib for Millennium Relapsed and injection; Pharmaceuticals refractory multiple proteasome inhibitor Inc. myeloma Xolair(R) Omalizumab; Genentech, Moderate to severe --------- recombinant DNA- Tanox Inc. persistent asthma derived humanized and Novartis in adults and monoclonal antibody Pharmaceuticals adolescents targeting immunoglobin-E (subcutaneous) Zavesca(TM) Miglustat; substrate Celltech Mild to moderate reduction therapy Group plc Gaucher's Disease (capsule) and Actelion patients for whom Ltd. enzyme replacement therapy is not an option New Indications Product Description Company Indication AVONEX(R) Interferon beta-1a; Biogen Treatment after --------- recombinant initial multiple sclerosis attack if a brain MRI scan shows abnormalities characteristic of the disease Betaseron(R) Interferon beta-1b; Chiron and New labeling ------------ recombinant Berlex includes data from Laboratories studies in patients Inc. with secondary progressive multiple sclerosis, and the indications section reflects Betaseron is indicated for treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations ENBREL(R) Etanercept; Amgen and Ankylosing --------- recombinant Wyeth spondylitis; product; dimeric improvement of fusion protein physical function consisting of tumor in patients with necrosis factor moderately to receptor linked to severely the Fc portion of active rheumatoid human IgG1 arthritis; expanded psoriatic arthritis label claiming blockage of progression FACTIVE(R) Gemifloxacin GeneSoft Community-acquired mesylate Pharmaceuticals pneumonia due to Inc. multi drug resistant Streptococcus pneumoniae GLIADEL(R) Polifeprosan 20 Guilford Newly diagnosed Wafer with carmustine Pharmaceuticals patients with implant Inc. high-grade malignant glioma as an adjunct to surgery and radiation Humatrope(R) Somatropin; Eli Lilly Long-term treatment ------------ recombinant and of children of Company short stature (unknown cause) PHOTOFRIN(R) Porfimer sodium; Axcan Ablation of high- PhotoDynamic photodynamic Pharma Inc grade dysplasia Therapy therapy in Barrett's esophagus patients who do not undergo esophagectomy REMICADE(R) Infliximab; Centocor Inc. Reduction of ----------- tecombinantly draining produced, chimeric enterocutaneous and monoclonal antibody recto-vaginal fistulas and for maintaining fistula closure in patients with fistulizing Crohn's disease Synagis(R) Palivizumab; MedImmune FDA cleared ---------- recombinantly Inc. addition of new produced, humanized safety and efficacy monoclonal antibody data supporting the drug's use in young children with hemodynamically significant congenital heart disease Zorbtive(TM) Somatropin; Serono Short bowel (Serostim(R)) recombinant syndrome (product previously approved under the trade name Serostim(R) for AIDS wasting) Sources: BioCentury, BioWorld, company reports and prescribing information for individual products. prnewswire.com