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			Brand Marketing Brand Institute is the premier full-service branding agency dedicated to strategic and innovative brand naming and identity solutions. We strive to exceed the expectations of every client by combining leading-edge market research with the highest levels of client service, integrity and brand management BIOGEN, ELAN CONFIRM THIRD CASE OF PML ASSOCIATED WITH TYSABRI; SHARES FALL ------------------------------------------------------------------------------- Biogen Idec Inc. and Elan Corp. Plc confirmed that a third patient who was treated with Tysabri (natalizumab), a drug approved in November 2004 as a treatment for multiple sclerosis and being tested to treat Crohn's disease and rheumatoid arthritis, developed progressive multifocal leukoencephalopathy (PML), a rare and often fatal disease of the central nervous system. The news caused shares in both companies to drop. The companies have been conducting comprehensive safety reviews of Tysabri clinical trials and have determined that the December 2003 death of a patient in a Crohn's disease trial was caused by PML and not by malignant astrocytoma, a type of brain tumor, as was originally thought. The companies said the patient had received eight doses of the drug in an 18-month period and had taken "multiple courses" of immunosuppressant agents prior to that. The companies are working with investigators and PML and neurology experts to evaluate approximately 3,000 patients enrolled in MS, Crohn's disease and rheumatoid arthritis trials involving Tysabri. "The results of this safety evaluation will be discussed with regulatory agencies to determine possible re-initiation of dosing in clinical trials and future commercial availability," the companies stated. The fact that the third patient developed PML without having taken other MS drugs, unlike the first two cases, "is a serious blow for Elan as it highlights Tysabri as the common factor in all three cases to date," Ian Hunter, an analyst with Goodbody Stockbrokers, told Reuters. According to Hunter and other analysts who spoke with Reuters, this development makes the availability of Tysabri for the U.S. market unlikely, particularly for the indications of Crohn's disease and rheumatoid arthritis. Hunter said if it does become available again as a treatment for MS, it will more than likely include restrictive labeling, "reducing the drug to a second-line treatment at most." Biogen and Elan suspended Tysabri sales in February after one patient died from PML while participating in an MS clinical trial of the drug in combination with Biogen's Avonex (interferon beta-1a). In early March, the companies confirmed a second trial patient's diagnosis of the same disease. Although the most recent news did not bode well for Biogen and Elan, it did boost shares of Serono SA, who partners with Pfizer Inc. on Rebif (interferon beta-1a), an approved MS therapy. Serono's shares rose $0.52, or 2.95 percent, to $18.15 on the New York Stock Exchange, while Biogen shares fell $3.84, or 10.01 percent, to $34.51 on the Nasdaq and Elan shares dropped $3.74, or 53.58 percent, to $3.24 on the New York Stock Exchange. -=- SCHERING-PLOUGH'S ASMANEX APPROVED FOR PREVENTIVE MAINTENANCE OF ASTHMA ------------------------------------------------------------------------------- Schering-Plough Corp.'s Asmanex (mometasone furoate) inhalation powder received approval from the Food and Drug Administration as a first-line maintenance treatment for asthma. The drug was also approved for use in patients who have received other treatments. The company said clinical studies showed that, compared with placebo, Asmanex substantially improved lung function and decreased the use of rescue medications, with patients reporting fewer nighttime awakenings and a lessening of daytime symptoms such as coughing and wheezing. Asmanex is the first inhaled asthma controller therapy approved for once-daily iniation and management of asthma in patients aged 12 years or older previously treated with bronchodilators alone or inhaled corticosteroids, according to Schering-Plough. "Asmanex is a highly effective first-line therapy that offers health care professionals and their patients a once-daily therapy to help prevent persistent asthma symptoms," said Dr. Harold Nelson, professor of medicine at the University of Colorado Health Science Center. -=- FDA GRANTS FAST TRACK DESIGNATION TO PTC THERAPEUTICS' CYSTIC FIBROSIS DRUG ------------------------------------------------------------------------------- The Food and Drug Administration granted fast track designation to PTC Therapeutics Inc.'s investigational drug candidate PTC124 for the treatment of cystic fibrosis. The "first-in-class" oral therapy was granted orphan drug designation in December to treat cystic fibrosis resulting from a nonsense mutation in the cystic fibrosis transmembrane regulator gene, the company said. Nonsense mutations prematurely halt the translation process in the genetic code, PTC explained, causing the production of nonfunctional proteins. PTC124 enables the cellular machinery to bypass the mutation, restoring the production of functional proteins. "We continue to make excellent progress in this program and believe that PTC124 has the potential to provide a treatment for [cystic fibrosis] patients who have the disease due to a nonsense mutation," said Stuart Peltz, Ph.D., chief executive officer of PTC. PTC estimated there are 30,000 cystic fibrosis patients in the United States, 10 percent of whom have the disease due to nonsense mutations. The company recently completed Phase I studies testing the drug in healthy volunteers and said it is working to finalize plans for Phase II studies to test the drug in patients with cystic fibrosis and Duchenne muscular dystrophy. -=- CEPHALON FILES NDA FOR NUVIGIL FOR TREATMENT OF EXCESSIVE SLEEPINESS ------------------------------------------------------------------------------- Cephalon Inc. filed a New Drug Application with the Food and Drug Administration for Nuvigil (armodafinil), a single-isomer formulation of Provigil (modafinil), another Cephalon product. The company seeks approval of Nuvigil as a treatment to improve wakefulness in patients with excessive sleepiness resulting from narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSA/HS) or shift work sleep disorder (SWSD). Cephalon based the NDA on four studies of Nuvigil in approximately 1,000 patients with excessive sleepiness associated with narcolepsy, SWSD or OSA/HS. Trial participants were randomized to receive Nuvigil 150 mg/day, Nuvigil 250 mg/d or placebo over a 12-week period. The primary endpoints of all four studies were measures of objective sleep latency and the physician rating of Clinical Global Impression-Change. As compared with the placebo group, Cephalon said patients treated with Nuvigil showed a statistically significant improvement in relation to both primary endpoints. In addition, results indicated that the drug appeared to be well tolerated and, when compared with placebo, did not disturb patients' regular sleep schedules. Cephalon said the studies also suggested that Nuvigil "is differentiated" from Provigil. "This is the third of five FDA approvals that we will be pursuing over a 15-month period," said Dr. Paul Blake, an executive vice president at Cephalon. -=- PHASE I TRIAL OF METABASIS, SANKYO'S CS-917 DIABETES DRUG RESUMES ------------------------------------------------------------------------------- Metabasis Therapeutics Inc. said a Phase I trial of CS-917, its diabetes drug being developed in a collaboration with Sankyo Co. Ltd., is continuing despite adverse events that halted trials of the drug last month. The companies suspended trials of the drug after two patients in an interaction study developed adverse events involving apparent lactic acidosis. The patients had also been taking metformin, a diabetes drug that has been associated with lactic acidosis. "While the recent findings in the CS-917 development program are unfortunate and the implication for the future of the program is yet to be determined, we remain cautiously optimistic that a path forward will be found," said Paul Laikind, Metabasis' chief executive officer. Metabasis said additional Phase I trials of the compound may be initiated to further test the drug and that the two companies are evaluating "what, if any, next steps should be taken in the CS-917 program." Metabasis also said it has discovered and developed a second-generation diabetes treatment, MB07803, that uses the same mechanism as CS-917. Depending on the outcome of the CS-917 review, clinical trials for MB07803 could begin within three to six months. Metabasis shares closed at $3.40, up $0.27, or 8.6 percent, in heavy trading on the Nasdaq. -=- STEMCELLS MOVES CLOSER TO INITIATING CLINICAL TRIAL ------------------------------------------------------------------------------- StemCells Inc. plans to resubmit its application to conduct the first-ever clinical trial using neural stem cells as a therapeutic agent, after recent discussions with the Food and Drug Administration. The company described feedback from the FDA as "supportive and encouraging" and said it plans to amend its original Investigational New Drug application for resubmittal. The proposed Phase I study would be the first FDA-approved trial to use "a purified composition of human neural stem cells as the potential therapeutic agent," the company said. StemCells hopes to develop its proprietary neural cell therapy, HuCNS-SC, for the treatment of infantile and late-infantile neuronal ceroid lipofuscinosis, the most severe forms of several progressive neural disorders commonly known as Batten disease. StemCells previously disclosed that the FDA's concerns were not related to contaminated embryonic stem cells, since, according to Reuters, the company uses human nerve stem cells isolated from normal brain tissue for its cell banks. "In the last 30 days we believe there has been positive and gratifying progress made between StemCells and the FDA," stated Martin McGlynn, StemCells' chief executive officer, adding that the company is "sensitive to and appreciate[s] the care with which the FDA is reviewing [the] IND for this trial." -=- FDA TO BAN CFCS IN METERED-DOSE INHALERS AFTER 2008 ------------------------------------------------------------------------------- The Food and Drug Administration will not allow albuterol metered-dose inhalers (MDIs) made with chlorofluorocarbon (CFC) propellants to be produced, marketed or sold in the United States beginning Jan. 1, 2009, the agency stated in a talk paper issued Thursday. In a final rule published in the Federal Register, the Department of Health and Human Services said that adequate supplies of environmentally friendly albuterol inhalers will be available by that time, allowing for the CFC versions to be phased out. The new CFC-free inhalers currently cost approximately $20 more than the older ones, Reuters reported. The HHS said manufacturers of the new inhalers are implementing programs, such as MDI giveaways, cost-saving coupons and financial-assistance programs, "to help assure access" for patients who cannot afford the new inhalers. CFC-containing albuterol MDIs and other CFC-based MDIs for asthma and chronic obstructive pulmonary disease were exempted from a previous CFC ban established through the U.S. Clean Air Act and the Montreal Protocol on Substances that Deplete the Ozone Layer. GlaxoSmithKline Plc and Ivax Corp. are among makers of albuterol inhalers that do not contain CFCs, Reuters noted. -=- Brand Marketing F. HOFFMAN-LA ROCHE AG ------------------------------------------------------------------------------- F. Hoffman-La Roche AG and Fujisawa Healthcare Inc. will partner on the promotion of Fujisawa's newly approved Mycamine (micafungin sodium). Mycamine was approved on March 16 to treat patients with esophageal candidiasis and for the prophylaxis of candida infections in patients undergoing stem cell transplant procedures. Under the agreement, Roche will promote the antifungal agent in the United States, and Fujisawa will compensate Roche based on sales of the product. -=- Brand Marketing SERONO SA ------------------------------------------------------------------------------- Serono SA and Syntonix Pharmaceuticals Inc. entered into an agreement to develop and market an inhalable interferon-beta treatment for multiple sclerosis. Under the agreement, Serono licensed worldwide, exclusive rights to Syntonix's Transceptor and Synfusion technologies. Serono, in partnership with Pfizer Inc., currently markets Rebif, an injectable interferon beta-1a treatment for the treatment of relapsing MS, and hopes to use Syntonix's technologies to develop a therapy that can be administered using an inhaler. Serono will be responsible for future development and marketing of the product. Syntonix will receive an up-front license fee and will be eligible for milestone and royalty payments. Further financial terms were not disclosed. -=- Brand Marketing IMMUNOGEN INC. ------------------------------------------------------------------------------- ImmunoGen Inc. submitted an Investigational New Drug application to the Food and Drug Administration for huC242-DM4, its tumor-activated prodrug (TAP) compound being developed to treat CanAg-expressing cancers, including gastrointestinal and non-small cell lung cancers. ImmunoGen expects to begin patient dosing with the TAP compound in mid-2005. -=- Brand Marketing THERATECHNOLOGIES INC. ------------------------------------------------------------------------------- Theratechnologies Inc., a Canadian biopharmaceutical company, said that it will begin two Phase III trials of ThGRF, a proposed treatment for HIV-associated lipodystrophy. The company said no treatments are currently approved for the metabolic syndrome, which affects as many as 200,000 HIV-positive patients undergoing antiretroviral therapy. The company estimates the market for this drug could be "several hundred million dollars." ThGRF is an analogue of the growth hormone-releasing factor (GRF) that causes the production and secretion of growth hormone. In a meeting with Theratechnologies on Wednesday, the Food and Drug Administration agreed to the trials' design, dosing and endpoints. The first trial is expected to begin by mid-year. -=- CORRECTION: ------------------------------------------------------------------------------- In the March 29 edition of Health Care Business Daily, we reported erroneous information in the story titled "Survey shows Bextra, Celebrex may benefit from FDA committee recommendations; Vioxx may not." An FDA advisory committee recommended that Pfizer Inc.'s Bextra (valdecoxib) and Celebrex (celecoxib) and Merck & Co. Inc.'s Vioxx (rofecoxib) carry black box warnings on cardiovascular risk. -=- Brand Marketing


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