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			Brand Name Search 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 FDA approves Alkermes, Cephalon's Vivitrol as treatment for alcohol dependence The Food and Drug Administration approved Alkermes Inc. and Cephalon Inc.'s Vivitrol (naltrexone) extended-release injectable suspension for the treatment of alcohol dependence. Vivitrol is the first and only once-monthly injectable treatment for alcohol dependence and is indicated for patients with alcohol dependency who can abstain from drinking in an outpatient setting and who are not actively drinking at the time treatment is initiated. Alkermes noted that Vivitrol should be used in conjunction with psychosocial support, such as counseling or group therapy. Researchers studied the drug's efficacy in a six-month, double-blind, Phase III randomized trial of patients with alcohol dependency. The primary endpoint of the trial was a reduction in the event rate of heavy drinking days; heavy drinking was defined as at least five drinks per day for men and at least four drinks per day for women. Results of the trial showed that patients who received Vivitrol 380 mg and psychosocial support demonstrated a greater reduction in heavy drinking days during the six-month treatment period as compared with those who received placebo and psychosocial support. Cephalon and Alkermes expect the drug to be available to physicians and patients by the end of June; it is to be administered as a single-dose 380 mg intramuscular injection. In June 2005, the companies entered into a joint commercialization agreement for Vivitrol; accordingly, Cephalon is primarily responsible for marketing and selling the drug, and Alkermes is responsible for manufacturing it. Based on this agreement and with the FDA approval, Cephalon will grant a milestone payment of $110 million to Alkermes. Brand Name Search Bayer officially makes acquisition offer of almost $20 billion for Schering AG Bayer AG issued its official offer to acquire Schering AG for approximately $19.98 billion. "The increase compared with the previously communicated figure of [approximately $19.53 billion] is primarily attributable to the fact that Schering AG has meanwhile issued shares from its own shareholding for fulfillment of employee options and will likely continue to do so during the validity period of the offer," title="branding company" Bayer explained. Schering has until the market closes on May 31 to accept the offer, which is approximately 61 percent higher than the unweighted 12-month average price for Schering shares, according to Bayer. "It is thus worthwhile for Schering shareholders to accept our offer," title="branding company" said Werner Wenning, Bayer's management board chairman. He added that Schering's management and supervisory boards support the acquisition. If a minimum shareholder acceptance threshold of 75 percent is reached by May 31, an additional acceptance period will most likely run from June 9 to June 22, Bayer said, noting that shareholders should not rely on accepting the offer during the additional period, as it will only be available if the 75 percent acceptance threshold is met by the earlier date. Bayer pointed out that "significant fluctuations in price" are possible depending on the acceptance rate for the offer. If the companies do merge, they will combine their pharmaceuticals businesses to create an independent division of Bayer HealthCare. The division would be named Bayer-Schering Pharmaceuticals and would operate from headquarters in Berlin. Brand Name Search Pfizer purchases rights to Schwarz Pharma's fesoterodine for overactive bladder Pfizer Inc. entered into an agreement with Schwarz Pharma AG, which will grant Pfizer exclusive worldwide rights to fesoterodine, an investigational drug designed to treat patients with overactive bladder. Schwarz submitted a New Drug Application for fesoterodine earlier this year with the Food and Drug Administration and with the European Medicines Evaluation Agency. Under the terms of the agreement, Schwarz will receive an initial payment from Pfizer of $100 million and is eligible to receive milestone payments that could total another $110 million. In addition, Schwarz is entitled to royalties on sales of fesoterodine and Pfizer's Detrol (tolterodine tartrate) products, which are also treatments for urinary conditions. Schwarz projected that annual sales of fesoterodine could reach approximately $547 million and said the drug could be available commercially by the end of 2007. The companies noted that the agreement settles all patent disputes between them regarding fesoterodine. Brand Name Search MGI Pharma submits NDA for oral mucositis therapy, releases Q1 outlook MGI Pharma Inc. submitted a New Drug Application for Saforis (glutamine) powder for oral suspension seeking the drug's approval in the prevention and treatment of oral mucositis in patients receiving mucotoxic cancer treatments. Saforis, which is designed to deliver high concentrations of glutamine into damaged oral mucosa, is delivered using MGI Pharma's UpTec system. The NDA includes data from several supportive studies and one pivotal Phase III trial that involved 326 patients with breast cancer who were being treated with anthracycline-based chemotherapy regimens. The Phase III trial met its primary endpoint of reducing the incidence and severity of oral mucositis, MGI Pharma said, noting that patients treated with Saforis had a 22 percent relative risk reduction of clinically significant oral mucositis compared with those who received placebo. Furthermore, only 1.2 percent of Saforis-treated patients experienced severe oral mucositis compared with 6.7 percent of placebo-treated patients, a difference that is significant, according to MGI Pharma. "The submission of the Saforis NDA marks a key milestone for MGI Pharma as we execute on our goal of advancing our pipeline of product candidates," said Lonnie Moulder, chief executive officer of the company. "We look forward to working closely with the Food and Drug Administration during the review process in order to bring this important supportive care product to cancer patients as quickly as possible." MGI Pharma also released its outlook for the first quarter of 2006. The firm expects to report a net loss of $0.03 to $0.05 per share on revenue of approximately $78 million. Sales of Aloxi (palonesetron hydrochloride) injection, a selective 5-HT3 receptor antagonist developed for the prevention of chemotherapy-induced nausea and vomiting, were lower than in the fourth quarter of 2005 due to "fewer emetogenic chemotherapy administrations and a continued competitive market." "Although less chemotherapy was administered early in the first quarter, we are encouraged that Aloxi continued to gain share from competing agents," said Moulder. "Based on our analysis of historical trends and early evidence from the oncology clinic market segment, we anticipate that chemotherapy administration will return to normal levels for the second through fourth quarters of 2006." Brand Name Search Sanofi-Aventis' Ketek improves asthma symptoms but not breathing capacity, trial results show A clinical study of Sanofi-Aventis Group's Ketek (telithromycin), an oral antibiotic, showed that the drug reduced some asthma symptoms in patients whose asthma had worsened but did not improve their breathing capacity. The double-blind trial included 278 adult patients who were enrolled within 24 hours of an acute exacerbation of asthma that required short-term medical care. The patients were randomized to receive Ketek 800 mg/day or placebo in addition to usual care for 10 days. The primary efficacy endpoints were a change in asthma symptoms from baseline during the treatment period and a change in the peak expiratory flow in the morning at home. Of these two endpoints, only the change in asthma symptoms was significantly greater among patients treated with Ketek than among those who received placebo. The results were based on a seven-point scale, with 0 denoting no symptoms and 6 denoting severe symptoms. The mean decrease in scores of asthma was 1.3 in the Ketek-treated group by the end of treatment, while patients' scores in the placebo group decreased by 1 point. Ketek showed no significant effect in terms of change in morning peak expiratory flow. The researchers noted that patients treated with Ketek experienced nausea more commonly than did those in the placebo group. These data were published in the April 13 issue of The New England Journal of Medicine. In January, Ketek was linked with three cases of severe hepatotoxicity. All three of the patients were previously healthy and presented with acute hepatitis within a few days of treatment with Ketek; none had been taking other prescription drugs at the time. One patient recovered, another underwent orthotopic liver transplantation and the last one died. The product's label advises of the potential for liver-related adverse events. Brand Name Search CNS, diabetes have strong pipelines in 2006, according to UnitedHealth executive Central nervous system drugs have the strongest pipeline for 2006, while diabetes drugs continue to grow at a fast pace, according to Brian Kolling, chief pharmacy officer at UnitedHealth Pharmaceutical Solutions and a presenter at the Annual Meeting and Showcase of the Academy of Managed Care Pharmacy in Seattle. In the last five years, CNS drugs have been repositioned in the market, Kolling said. The CNS market had been focused on treatments for schizophrenia, migraine and epilepsy, with selective serotonin reuptake inhibitors being used to treat depression, anxiety, obsessive compulsive disorder and panic disorder. In today's market, however, the focus is on bipolar disorder, sleep drugs, addiction therapeutics and "epilepsy drugs being used to treat everything but epilepsy," according to Kolling. Some CNS drugs on the horizon are Neurocrine Biosciences Inc. and Pfizer Inc.'s indiplon, which has the proposed brand name Somposure and is intended to treat insomnia; Shire Pharmaceuticals Group Plc and New River Pharmaceuticals Inc.'s NRP104, which is intended to treat attention-deficit/hyperactivity disorder in children aged 6 to 12 years; and GlaxoSmithKline Plc's Trexima (sumatriptan succinate/naproxen sodium), which is intended to treat migraine. New Drug Applications for indiplon tablets and capsules have been filed and a decision by the Food and Drug Administration is expected in May, Kolling said. A decision on Trexima is expected in June, and an NDA for NRP104 was filed last December. The diabetes market also has some notable new drugs in the pipeline, Kolling said. Although Bristol-Myers Squibb Co.'s Pargluva (muraglitazar) may no longer come to market (the FDA has requested more data about the drug's cardiac safety profile), several other peroxisome proliferator-activated receptors are being developed, he explained. Inhaled insulins continue to be a big part of the diabetes pipeline, with Pfizer's Exubera (inhaled human insulin powder) recently receiving approval. Kolling noted that approximately 80 drugs are in the diabetes pipeline for 2006, which is up from less than 50 products in 2003. Drugs to watch in the diabetes category include Merck & Co. Inc.'s Januvia (sitagliptin), for which an NDA was filed in December, Novartis AG's Galvus (vidagliptin), for which an NDA was filed in March, and BMS' saxagliptin, which is currently in Phase III trials. Kolling pointed out that these drugs, all of which are dipeptidyl peptidase IV inhibitors, could reach blockbuster status after they are approved. Brand Name Search Brand Name Search Medtronic Inc. Medtronic Inc.'s MiniMed Paradigm real-time insulin pump and glucose monitoring system received approval from the Food and Drug Administration as a therapy for patients who use insulin to treat diabetes. The device comprises two components: a real-time continuous glucose monitoring system and a MiniMed Paradigm insulin pump. The monitoring system relays glucose readings to the pump every five minutes. Medtronic said the new technology is designed to help patients take immediate preventive or corrective action to maintain healthy glucose levels and to prevent or delay diabetes-related complications. Brand Name Search Brand Name Search Watson Pharmaceuticals Inc. Watson Pharmaceuticals Inc. completed its acquisition of Sekhsaria Chemicals Ltd., an India-based firm that specializes in process research and development and contract manufacturing. "Sekhsaria's unique active pharmaceutical ingredients capabilities will support our generic pharmaceutical program needs," said Allen Chao, Watson's chief executive officer. "Together with our recently acquired manufacturing facility in Goa, India, our India-based technical operations are firmly established, providing Watson with a broad range of pharmaceutical capabilities." He added that these off-shore acquisitions will help Watson continue "to improve efficiencies and manage costs." Brand Name Search Brand Name Search Cortex Pharmaceuticals Inc. Cortex Pharmaceuticals Inc. received a written update from the Food and Drug Administration regarding the clinical hold that was recently placed on the firm's CX717 ampakine compound, which is being assessed for its ability to reduce excessive daytime somnolence. The notice explains why the agency placed the compound on clinical hold, a decision that was based on preclinical animal data, and describes what actions Cortex should take to have the hold removed. Cortex said it "has begun the process to arrange for discussions with the appropriate experts within the agency to translate the request into specific acute preclinical studies related to the issues and recommendations provided by the agency." title="branding company" Brand Name Search Brand Name Search Athenagen Inc. Athenagen Inc. acquired the assets of Osprey Pharmaceutical Co., including a compound designed to target Alzheimer's disease and related analogs. The lead compound, GTS-21, an orally active alpha-7 nicotinic acetylcholine receptor agonist, has demonstrated memory and cognition enhancement activity in Phase I studies. Other acquired assets include intellectual property, preclinical and clinical data and an active Investigational New Drug application for GTS-21. Financial terms of the agreement were not disclosed. Brand Name Search


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