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			Register a Company Name 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 Idec, Elans Tysabri receives unanimous vote from FDA panel to return to market An advisory panel voted unanimously that Biogen Idec Inc. and Elan Corp. Plc's multiple sclerosis drug, Tysabri (natalizumab), should return to the market with a cautionary statement to closely monitor patients for a potentially fatal complication, Reuters reported. The companies voluntarily suspended sales of the drug in February 2005 after two patients died from a brain and spinal cord infection known as progressive multifocal leukoencephalopathy. A third patient developed the infection and survived. The Food and Drug Administration advisory panel members voted 12-0 that sales of Tysabri could resume if the firms create a mandatory patient registry to track possible side effects and enforce other controls, according to Reuters. The panel also voted 7-5 that Tysabri could be considered as a first-choice treatment for some patients with MS. The panel members said that many patients with MS are not adequately improved by current drugs and should have Tysabri as an option, Reuters stated. "Most people in (Tysabri) studies did not have a relapse and did not have disability progression," Dr. Karl Kieburtz, the panel's chairman, said in the Reuters report. Geoff Porges, an analyst at Sanford Bernstein, said that Tysabri sales could reach $700 million annually by 2010, Reuters reported. Porges predicted that, if approved, Tysabri will be a slow build because physicians and patients will be well cautioned. "This is not going to become a routine drug in the next year or two," he said. Register a Company Name Gilead's HIV drugs Viread, Truvada receive traditional FDA approval Gilead Sciences Inc. was granted traditional approval status from the Food and Drug Administration for two of its HIV treatments, which were previously approved under accelerated approval status. The approval will allow the company to include more information in the drugs' labeling. The FDA issued the approval for once-daily antiretrovirals Viread (tenofovir disoproxil fumarate) and fixed-dose Truvada (emtricitabine/tenofovir disoproxil fumarate), which combines Viread and Gilead's antiretroviral Emtriva (emtricitabine). Gilead will include information from a second 48-week Phase III study that was published in the Jan. 19 issue of The New England Journal of Medicine. The study confirmed the drugs' efficacy in treatment-naive patients by comparing a once-daily regiment of Viread, Emtriva and Bristol-Myers Squibb Co.'s Sustiva (efavirenz) with GlaxoSmithKline Plc's twice-daily Combivir (lamivudine/zidovudine) and once-daily Sustiva. Of the patients in the Viread/Emtriva group, 84 percent achieved and maintained HIV RNA less than 400 copies/mL through week 48 compared with 73 percent of patients in the Combivir group. Gilead noted that the numbers varied between the groups mainly due to adverse events in the Combivir group resulting in a high rate of discontinuance. The study also showed that 80 percent of patients in the Viread/Emtriva group maintained HIV RNA less than 50 copies/mL compared with 70 percent of patients in the Combivir group. Gilead and BMS established a joint plan to produce a once-daily fixed dose of an HIV treatment containing Truvada and Sustiva. The companies expect to file a New Drug Application in the second quarter. If approved, the drug would be the only complete highly active antiretroval therapy regime for the treatment of HIV that is available in a single once-daily fixed-dosed tablet. Gilead shares closed at $60.78, up $1.69, or 2.9 percent, in moderate trading on the Nasdaq. Register a Company Name Neurocrine ends MS program after study's endpoint not met Neurocrine Biosciences Inc. ceased the development of NBI-5788, the company's investigational altered peptide ligand technology for the treatment of multiple sclerosis (APL-MS), after it failed to meet its primary endpoint in a Phase II study. In the double-blind trial, 157 patients with relapsing MS were randomized to 5 mg injections of NBI-5788 or placebo administered in five weekly doses followed by eight monthly doses to evaluate the safety, tolerability and disease-modifying effects of the drug. Prior Phase II trial results suggested clinical improvement for patients who were administered the lowest dose (5 mg). Data from the study demonstrated that the drug was safe and well tolerated, but was not efficacious. Neurocrine will continue to conduct Phase II studies of NBI-6024, an APL therapy to treat type 1 diabetes, and will review this program based on results expected in the third quarter of this year. Register a Company Name Boston Scientific submits final PMA module for Taxus Liberte drug-eluting stent Boston Scientific Corp. submitted the final module of its Premarket Approval Application for the Taxus Liberte paclitaxel-eluting coronary stent system to the Food and Drug Administration. The module includes nine-month data from the ATLAS trial. These data will be released at a medical conference in May, Boston Scientific said. "As the next generation to our market-leading Taxus Express2 system, the Taxus Liberte system combines the proven benefits of our drug-eluting technology with excellent deliverability and conformability, particularly in challenging lesions," said Jim Tobin, chief executive officer of Boston Scientific. Tobin added that the stent has already been launched internationally, where it has "achieved a leadership position in virtually every market where it is sold." Boston Scientific is in the process of resolving manufacturing issues raised in a corporate warning letter it received from the FDA in January. Until the firm resolves these issues, the FDA said it will not approve any Boston Scientific PMAs. Last April, the FDA approved the Liberte bare-metal coronary stent system in the United States. Register a Company Name Galderma's Differin works well in combination with other acne treatments, study finds Galderma Laboratories LP's Differin (adapalene) 0.1% gel improves the efficacy of an acne regimen when combined with other acne treatments, a Phase IV trial found. The observational MORE trial involved approximately 1,979 patients with acne. Patients were studied for a 12-week period while they received treatment regimens recommended by their dermatologists. All regimens included Differin in combination with other therapies. Researchers assessed the patients at baseline, six weeks and 12 weeks. A 65 percent reduction was seen in comedones and inflammatory lesions during the 12-week treatment period with Differin, Galderma said. The firm added that 64 percent of patients found Differin to be superior to other treatments for acne when it was used in combination therapy. Furthermore, there was an 86 percent satisfaction rate among patients treated with Differin. "What's significant about the MORE trial is that many different treatment strategies are represented; therefore the trial is representative of the real world," said Dr. John Wolf, a professor at Baylor College of Medicine's department of dermatology and a member of the trial's steering committee. "Differin gel 0.1%, when combined with many different products, yielded reliable improvements with excellent tolerability and patient satisfaction and can be regarded as an ideal topical retinoid preparation." These data were presented at the 64th annual meeting of the American Academy of Dermatology in San Francisco. Register a Company Name Heart Failure Society of America releases new treatment guidelines for heart failure The Heart Failure Society of America recently released its first new guidelines in seven years for treating patients with heart failure. The guidelines focus on evaluating, caring for and managing patients with HF, including patients with acute HF and HF in specific populations. For example, the guidelines recommend that black patients with left ventricular systolic dysfunction be treated with a combination of hydralazine hydrochloride and isosorbide dinitrate in addition to beta blockers and ACE inhibitors. NitroMed Inc. sells isosorbide dinitrate and hydralazine in combination as BiDil. As an adjunct to standard therapy, BiDil is approved to improve survival, prolong time to hospitalization for HF and improve patient-reported functional status in self-identified black patients. The updated guidelines also make recommendations to prevent HF. They recommend beta blocker treatment for patients with prior myocardial infarction and ACE inhibitor treatment for high-risk patients, such as those with coronary artery disease, peripheral vascular disease or stroke. The guidelines specify that patients with diabetes who smoke or have microalbuminuria or another risk factor are also at high risk for HF and should take ACE inhibitors. Furthermore, the guidelines discuss the use of the latest medical devices in treating HF. "Use of new devices has witnessed an explosive growth," said Dr. Gary Francis, president of the HFSA. "We're using more defibrillators now. We're using more biventricular pacemakers. We are likely going to see these new devices used in the earlier stages of HF." The HFSA noted that these guidelines, which can be found in the February issue of the Journal of Cardiac Failure, should be seen as a "living document" and will be updated as new information is made available. Register a Company Name Register a Company Name Merck & Co. Inc. Merck & Co. Inc.'s MK-524B, an experimental drug designed to raise HDL cholesterol, ran into problems with its formulation, but the company said it expects to file an application for marketing approval in 2007, according to Reuters. The drug was supposed to combine three drugs: Merck's cholesterol-lowering drug Zocor (simvastatin); the HDL cholesterol-raising nutrient niacin; and a chemical that Merck is developing as a prophylaxis for facial flushing often caused by niacin. In upcoming trials, the company plans to administer the drugs by giving Zocor separately from niacin and the flushing inhibitor. Merck plans to bridge the data from these trials to demonstrate that the results are equivalent to the combination product, Reuters noted. Register a Company Name Register a Company Name Novartis AG Novartis AG exercised its license option to develop and commercialize an oral parathyroid hormone (PTH) for treating osteoporosis using Emisphere Technologies Inc.'s eligen delivery technology, which enables therapeutic molecules to be orally delivered without altering their biological integrity or chemical form. Emisphere is eligible for milestone payments of up to $30 million, plus royalties on product sales. The execution of this license follows a recent federal court decision that favored Emisphere in its litigation over an oral PTH agreement with Eli Lilly and Co. The court ruled that Lilly breached contractual obligations and that the agreement between Lilly and Emisphere had been properly terminated, which allowed the Novartis agreement to take effect. Register a Company Name Register a Company Name Alpharma Inc. Alpharma Inc. agreed to sell its generic pharmaceutical telemarketing distribution business, ParMed Pharmaceuticals Inc., to Cardinal Health Inc. for $40.1 million in cash. "The recent sale of Alpharma's generics business created a stronger, more focused platform for maximizing shareholder value," title="branding company" said Ingrid Wiik, Alpharma's chief executive officer, referring to the division's October sale to Actavis Group. "The sale of the ParMed business further streamlines and focuses the company around its three continuing businesses with solid market positions and strong growth potential." Alpharma's board of directors has approved the ParMed sale, and it is expected to close in the first quarter of this year. Register a Company Name Register a Company Name CoTherix Inc. CoTherix Inc. initiated a Phase III trial of Ventavis (iloprost) inhalation solution in combination with Pfizer Inc.'s Viagra (sildenafil citrate) that will evaluate the drugs' safety and efficacy in treating pulmonary arterial hypertension. The VISION trial will also include an arm to study the efficacy of less frequent Ventavis dosing as suggested by peer-reviewed publications. The trial will include approximately 180 patients with PAH who take a stable dose of Viagra. Patients will be randomized to receive Ventavis four doses per day, six doses per day or placebo. The primary endpoint is an increase in the distance walked in six minutes. Register a Company Name


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