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			New Company Names 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 warns of Trasylol side effects The Food and Drug Administration issued a public health advisory to physicians and their patients warning that Bayer Pharmaceuticals Corp.'s Trasylol (aprotinin) injection, a drug used to prevent blood loss during surgery, may increase the risk of serious side effects. The FDA requests physicians monitor patients for the occurrence of toxicity, particularly to the kidneys, heart and central nervous system, and report all adverse events to Bayer or the FDA MedWatch program. The advisory also encourages physicians to limit Trasylol use to situations where the benefit of reduced blood loss outweighs the potential risks of the drug. The risks, which the FDA identified based on findings reported in The New England Journal of Medicine and Transfusion, include kidney problems, myocardial infarction and strokes in patients who undergo artery bypass graft surgery. The studies included patients who were selected by physicians to receive Trasylol; the patients who were selected for the studies may have been sicker than other patients, the FDA noted. The FDA is evaluating the studies closely, as well as other scientific literature and reports submitted to the agency through the MedWatch program. The FDA is expected to determine if labeling changes or other actions are warranted in an advisory committee later this year. In January, Bayer issued a statement to refute the Trasylol study published in the NEJM. The firm said the data were inconsistent with more than 15 years of data that have been collected by Bayer. New Company Names Cell Therapeutics' Xyotax receives fast track designation The Food and Drug Administration granted fast track status to Cell Therapeutics Inc.'s Xyotax (paclitaxel poliglumex), an investigational treatment of first-line advanced non-small cell lung cancer in women with poor performance status (PS2). Xyotax is being investigated in the PIONEER trial, which is the first approval trial exclusively targeting women with lung cancer. The trial will take place at approximately 170 sites; half will be in the United States and the remainder will take place in Eastern Europe, Latin America and other locations throughout the world. The company expects to enroll 600 PS2 chemotherapy-naïve women with advanced stage NSCLC in the trial. Xyotax is a biologically enhanced version of one of the most used cancer drugs, paclitaxel, plus a biodegradable polyglutamate polymer. Cell Therapeutics shares closed at $2.03, up $0.19, or 10.3 percent, in heavy trading on the Nasdaq. New Company Names Adolescents show high placebo response during recent trial of Zomig for migraines In a recently published trial, AstraZeneca Plc's Zomig (zolmitriptan) and placebo demonstrated similar efficacy in adolescents who experienced migraines, a result attributed to a high placebo response. The double-blind trial included 850 adolescents aged 12 to 17 years who experienced migraine with or without aura according to International Headache Society 1988 criteria. Along with a minimum of a one-year history of migraines, a duration of at least four hours for all untreated migraines and the ability to differentiate between nonmigraine and migraine headaches without aura, the patients must have experienced at least two migraines and up to 10 headaches per month in the three months prior to study screening. Patients were instructed to take placebo or 2.5 mg, 5 mg or 10 mg of Zomig to treat a single migraine during the 12 weeks of randomization when the following criteria were met: not more than one hour had passed since the migraine began or the patient first noticed it; more than 24 hours had passed since a prior migraine ended; the headache pain was rated as moderate or severe on a four-point rating scale; neither 5-HT1B/1D agonists nor ergotamines had been consumed in the prior 24 hours; no monoamine oxidase type A inhibitors had been taken within two weeks of randomization. An approved escape drug could be taken two hours after administration of the study drug and after the patient had recorded a post-treatment rating. A total of 696 patients were included in the intent-to-treat analysis and 699 in the safety evaluation. The rates of the primary efficacy endpoint of headache response (defined as improvement in migraine pain from moderate or severe at dosing to mild or none two hours post-dose) were not statistically significantly different between the 10 mg Zomig and placebo arms (54 percent vs. 58 percent, respectively). A similar trend occurred for headache responses one hour and 30 minutes after dose administration. The researchers found that the placebo group had higher two-hour response rates than any of the Zomig arms, although no statistical analyses were conducted to compare the rates of the 5 mg and 2.5 mg Zomig dose groups (53 percent and 57 percent, respectively) with that of placebo, "[b]ecause a step-down approach was taken to control the overall type I error rate at 5 percent." The rates of pain freedom, or a decrease in migraine pain severity from severe or moderate at dosing to no pain, also did not statistically significantly differ between the placebo and Zomig groups two hours after dosing (placebo, 20 percent; 2.5 mg, 23 percent; 5 mg, 19 percent; and 10 mg, 25 percent). The incidence of at least one adverse event was also higher among the Zomig-treated patients (range, 29 percent to 44 percent) as compared with the placebo-treated subjects (15 percent); the overall rate was highest in the 10 mg treatment group. The study investigators explained that the two-hour response rates among the young patients who received Zomig was similar to rates observed in adult trials, but the placebo response rates were much higher in the adolescents than the placebo response rates observed in adult trials. They put forth several explanations for the high placebo response rates observed in this trial. For one, IHS criteria have been updated since 1988 to differentiate between adults and children. For another, it may have been necessary for the younger patients to take the drugs and rate their headache intensity while at school, which may have created problems related to timing. "These delays, coupled with the shorter duration of migraine headache in adolescents compared with adults, could mean that headache pain had resolved spontaneously two hours after treatment, nullifying any advantage of drug therapy," the investigative group postulated. The authors suggested that shorter timepoints for headache response and pain-free rates, more sensitive rating scales for pain intensity and the use of a composite endpoint that includes changes in functional impairment may address the high placebo response rates in future trials of adolescents. These data appeared in the January issue of the journal Headache. New Company Names Entereg statistically significantly accelerates time to GI function recovery after bowel resection surgery GlaxoSmithKline Plc and Adolor Corp.'s investigational Entereg (alvimopan) met the primary and secondary endpoints of a Phase III trial, accelerating the time to recovery of gastrointestinal function after bowel resection surgery. Entereg is intended to preserve the analgesic effects of opioids, but to inhibit their negative effects on the GI system. In this way, it works to help manage postoperative ileus, an intestinal obstruction that can occur after surgery and lead to vomiting, colic and constipation. In the present trial, 654 patients were scheduled to undergo large or small bowel resection surgery and were randomized to receive either 12 mg of Entereg or placebo two times daily. The protocol called for the initial dose to be administered 30 minutes to 90 minutes before the surgery. The primary endpoint was the time to recovery of GI function. A statistically significant difference occurred between the groups with regard to the primary endpoint, with the Entereg-treated patients recovering GI function an average of approximately 20 hours sooner than the placebo-treated group. "Furthermore, the [Entereg] treatment group exhibited a significant reduction in complications related to postoperative ileus," said Dr. Conor Delaney, one of the study investigators. The firms received an approvable letter for Entereg in July for managing postoperative ileus. At that time, the Food and Drug Administration requested that the companies conduct a study showing that those who underwent bowel resection and received Entereg experienced a clinically meaningful average reduction in time to GI function recovery. They were also asked to show statistically significant results in at least one additional study. Adolor shares closed at $22.29, up $6.53, or 41.4 percent, in heavy trading on the Nasdaq. New Company Names Several factors result in higher sales, income for GSK in Q4, full-year GlaxoSmithKline Plc reported earnings growth in the fourth quarter of 2005, boosted by lower expenses and legal costs, favorable exchange rates and high sales of its asthma drug Advair Diskus (fluticasone propionate/salmeterol xinofoate) and diabetes drug Avandia (rosiglitazone maleate). The company experienced turnover growth of 8 percent at constant exchange during the quarter, reaching approximately $10.28 billion from approximately $9.11 billion in the prior-year period. The highest-selling drug products were Advair, which is marketed as Seretide in the United Kingdom, with quarterly sales of approximately $1.48 billion, and Avandia, which reached approximately $500 million in sales. Profit after taxation increased to approximately $1.99 billion, jumping 31 percent at constant exchange from approximately $1.39 billion in the fourth quarter of 2004. Per share, diluted earnings increased from approximately $0.24 to approximately $0.34. For the full year, turnover rose 7 percent at constant exchange to approximately $39.42 billion, which included approximately $5.47 billion in Advair sales and approximately $2.1 billion in Avandia sales. GSK said its yearly profit after taxes reached approximately $8.77 billion, reflecting a 17 percent constant exchange increase from approximately $6.99 billion. Earnings per diluted share increased from approximately $1.18 to approximately $1.49. Both earnings per share and revenue for the year were slightly above analysts' forecasts compiled by Thomson First Call, MarketWatch reported. "Looking into 2006, the strong growth seen from key products such as Seretide/Advair, Avandia and from our vaccines business is set to continue, and we expect further good news on GSK's late-stage pipeline. Eight major assets are scheduled to enter Phase III in 2006--this will double the number of assets in late-stage development," said J.P. Garnier, GSK's chief executive officer. He added that the firm expects to file for U.S. regulatory approval of its Cervarix human papillomavirus vaccine before the end of this year. For 2006, GSK anticipates earnings per share will grow by 10 percent at constant exchange, a prediction that is slightly above the 9 percent estimate of analysts polled by Thomson First Call, MarketWatch added. GSK shares closed at $50.95, up $0.64, or 1.3 percent, in moderate trading on the New York Stock Exchange. New Company Names Dr. Reddy's bids for betapharm Indian company Dr. Reddy's Laboratories Ltd. bid against rival Ranbaxy Laboratories Ltd., India's largest pharmaceutical firm, for betapharm Arzneimittel GmbH, The Wall Street Journal reported. Betapharm is Germany's fourth-largest maker of generic drugs. A Ranbaxy spokesman would neither "confirm nor deny" its interest in betapharm, according to The Journal. Indian newspaper the Business Standard reported that Ranbaxy's bid was approximately $597.5 million, while Dr. Reddy's bid was approximately $59.7 million more than Ranbaxy's. The Business Standard also reported that Teva Pharmaceutical Industries Ltd. and sanofi-aventis Group are in the bidding mix. In May 2004, control of betapharm was acquired by 3i, a London-based private equity firm. 3i hired investment banks Sal. Oppenheim and Bear Stearns, which "are considering a number of offers [for betapharm]," title="branding company" according to The Journal. 3i has not yet made a decision on whether to divest its holding. If Dr. Reddy's or Ranbaxy were to acquire betapharm, it would be the largest overseas acquisition by an Indian pharmaceutical company, The Journal noted. New Company Names New Company Names Eli Lilly and Co. Eli Lilly and Co. launched a new pre-mixed insulin called Humalog Mix 50/50 (50% insulin lispro protamine suspension/50% insulin lispro injection [rDNA origin]), which helps to control high blood sugar in patients with diabetes and is available in a pen delivery device. The new formulation lowers blood sugar more quickly than regular human insulin, providing convenient dosing immediately before a meal, the firm said. New Company Names New Company Names AstraZeneca Plc AstraZeneca Plc and NPS Pharmaceuticals Inc. extended their alliance relating to the discovery, development and commercialization of new drugs that target metabotropic glutamate receptors to treat disorders of the central nervous and gastrointestinal systems. Under the new agreement terms, the companies will continue their research collaboration for at least three years, with options to extend it for another two years. AstraZeneca is currently conducting Phase I activities with an active molecule discovered through the collaborative effort. New Company Names New Company Names Oscient Pharmaceuticals Corp. Oscient Pharmaceuticals Corp. acquired expanded rights to its lead clinical candidate, Ramoplanin, an investigational treatment for Clostridium difficile-associated disease, from Vicuron Pharmaceuticals Inc., a Pfizer Inc. subsidiary. Oscient previously licensed Ramoplanin from Vicuron for the United States and Canada only. Under the terms of the agreement, Oscient acquired the worldwide rights to the drug and is responsible for manufacturing, developing and commercializing the drug on a global basis. Oscient has made a one-time, up-front payment to Pfizer, which will also receive additional milestone payments and royalties on net sales. New Company Names New Company Names ReGen Therapeutics Plc ReGen Therapeutics Plc agreed to acquire privately held Sciencom Ltd., a process expected to be completed Feb. 14. Sciencom is developing a new use for zolpidem, which is currently sold by sanofi-aventis Group as Ambien (zolpidem tartrate) to treat insomnia. A Phase II study is planned this year to evaluate the drug as a therapy for brain dormancy and/or diaschisis (the breaking up of certain brain activity due to injury). ReGen will pay Sciencom up to nearly $218,000 plus potential royalty options. New Company Names


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