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Name DesignBrand 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 NEXIUM INTRAVENOUS FORMULATION RECEIVES FDA APPROVALAstraZeneca Plc received approval from the Food and Drug Administration for an intravenous formulation of its proton pump inhibitor, Nexium (esomeprazole magnesium), for short-term treatment of gastroesophageal reflux disease. Nexium I.V. will be available in an injection or infusion form for patients with a history of erosive esophagitis who are unable to tolerate the oral version. Patients can receive a once-daily, 10- to 30-minute infusion, or an injection lasting no less than three minutes. The drug is approved for treatment up to 10 days. AstraZeneca said the approval was based on the results of four multicenter, open-label, two-period crossover studies with Nexium I.V. After 10 days of once-daily administration, results suggested Nexium I.V. (20 mg and 40 mg) had similar acid suppression activity to the corresponding oral doses. There were also no relevant changes in acid suppression when patients switched between Nexium I.V. and the oral form. The European Mutual Recognition Process first approved Nexium I.V. in August 2003, and Nexium capsules have been made available in 89 countries, The Wall Street Journal reported. -=- SOLVAY'S CILANSETRON NOT APPROVABLE WITHOUT ADDITIONAL TRIALS Solvay Pharmaceuticals Inc. received a letter from the Food and Drug Administration that deemed cilansetron not approvable. The letter requests that Solvay conduct additional clinical trials of the drug, which is intended to treat irritable bowel syndrome with diarrhea predominance (IBS-D). IBS-D is associated with diarrhea, abdominal pain and discomfort and fecal urgency. The condition negatively impacts the quality of life of millions of Americans, the company said. Solvay is "examining its options" and plans to discuss future steps with the FDA regarding cilansetron. -=- J&J MODIFIES REMINYL PRESCRIBING INFORMATION DUE TO PATIENT DEATHS IN TRIALS Johnson & Johnson modified the precautions section of its prescribing information for Reminyl (galantamine hydrobromide), a treatment for mild to moderate Alzheimer's disease. The new warning includes information about two trials in which 13 patients died while taking Reminyl for mild cognitive impairment (MCI), compared with the death of only one patient receiving placebo. J&J clarified that it is not seeking an indication for Reminyl to treat patients with MCI. The patient deaths "were due to various causes that could be expected in the elderly population," according to a letter the company sent out to health care professionals. Nearly half of the deaths appeared to result from vascular causes, including myocardial infarction, stroke and sudden death. Despite the statistical significance between the number of deaths in the two groups, the company said that the comparison between patients taking Reminyl and those taking placebo is misleading, as the mortality rate in the placebo-treated patients was "markedly lower" than that of placebo-treated patients in other trials of the drug. Furthermore, according to the company, no patients receiving placebo in the MCI trials died after six months, which is "a highly unexpected finding in this population." -=- ALKERMES SUBMITS NDA FOR MONTHLY INJECTABLE VIVITREX ALCOHOL DEPENDENCE TREATMENT Alkermes Inc. submitted a New Drug Application to the Food and Drug Administration for marketing approval of Vivitrex (naltrexone) long-acting injection for the treatment of alcohol dependence. If the FDA approves the drug, the company said Vivitrex would be the first alcohol dependence treatment available for administration once a month by injection. Vivitrex was developed using Alkermes' Medisorb drug delivery technology, which is used to contain naltrexone in a biodegradable polymer that dissolves and releases the drug at a controlled rate. "The NDA submission is a major milestone in our Vivitrex development program, which compromises a comprehensive U.S. clinical trials program, manufacturing infrastructure and extensive regulatory and research expertise," said Richard Pops, chief executive officer of Alkermes. -=- SUCAMPO SUBMITS NDA FOR LUBIPROSTONE FOR TREATMENT OF CHRONIC IDIOPATHIC CONSTIPATION Sucampo Pharmaceuticals Inc. submitted a New Drug Application to the Food and Drug Administration for its drug lubiprostone for the treatment of chronic idiopathic constipation and associated symptoms in adults. The novel treatment, which is administered orally, works locally in the gastrointestinal (GI) tract by activating specific chloride channels on cells lining the small intestine, thereby increasing intestinal fluid secretion, the company said. Contingent upon FDA approval, Takeda Pharmaceutical Co. Ltd.'s U.S. subsidiary will market lubiprostone in the United States, according to an agreement reached in October 2004 that gave Takeda marketing rights in the United States and in Canada. The drug will be manufactured and supplied by R-Tech Ueno Ltd., a member of Sucampo Group. "[L]ubiprostone produced rapid and sustained effects in treating the symptoms of constipation" in two Phase III trials, the company said, also noting that the drug showed no rebound effect after treatment was discontinued. Sucampo is in the process of investigating possible indications for lubiprostone in the treatment of constipation-predominant irritable bowel syndrome and other GI disorders. "Our studies suggest that lubiprostone's unique mechanism of action may offer a more targeted approach to managing the symptoms of constipation," said Sachiko Kuno, Ph.D., chief executive officer of Sucampo. -=- CRITICAL THERAPEUTICS SUBMITS SNDA TO FDA FOR ZYFLO Critical Therapeutics Inc. submitted a supplemental New Drug Application to the Food and Drug Administration for Zyflo (zileuton) Filmtab tablets for the prevention and treatment of asthma. Approval would allow the company to market its version of Zyflo in the United States. Zyflo was approved by the FDA in 1996 for the prevention and chronic treatment of asthma in patients aged 12 years or older, but it has been commercially unavailable since early 2004 when supply was depleted, though a clinical supply is currently available through an open-label Phase IIIb study for patients who previously used the drug and need it to control their symptoms. Critical Therapeutics is required to submit an sNDA because of changes in the manufacturing process and because the company transferred production of the active pharmaceutical ingredient and tablet formulation to third-party sites. The company expects to launch Zyflo in the second half of 2005, "contingent upon regulatory approval." "Zyflo is the only asthma treatment that blocks the activity of the enzyme responsible for producing an array of inflammatory mediators, most notably leukotrienes," said Dr. Paul Rubin, chief executive officer of Critical Therapeutics. "We believe this novel mechanism will allow Zyflo to occupy a unique position in the treatment of asthma." -=- BIOGEN IDEC RETRACTS 2005 FINANCIAL GUIDANCE AFTER WITHDRAWAL OF TYSABRI Biogen Idec Inc. withdrew its 2005 financial guidance following voluntary suspension of its multiple sclerosis drug, Tysabri (natalizumab), and three cases of brain infection in connection with its use, according to company filings with the Securities and Exchange Commission. The company said on Feb. 7 that its 2005 earnings per share, excluding one-time items, would be between $1.60 and the low $1.70s, but Biogen said that "investors should no longer rely on" this guidance. The company also said it earned $28.7 million, or $0.08 cents per share, for the fourth quarter, rather than its previous earnings announcement of $48.4 million, or $0.14 cents per share, The Wall Street Journal reported. Biogen and its partner, Elan Corp. Plc, halted sales of Tysabri on Feb. 28 after one patient participating in clinical trials of Tysabri for the treatment of MS died from complications of progressive multifocal leukoencephalopathy (PML), a rare type of brain infection. Two more cases, including one death, of PML in connection with Tysabri have been identified. In the most recent case, the patient was receiving Tysabri in a clinical trial for the treatment of Crohn's disease. Biogen and Elan are continuing to examine medical records of approximately 3,000 patients enrolled in the Phase III trials for treatment of multiple sclerosis, Crohn's disease and rheumatoid arthritis. -=- Name Design SANOFI PASTEUR Sanofi pasteur, the vaccines unit of sanofi-aventis Group, was awarded a $97 million contract from the Department of Health and Human Services to expedite the production of new cell culture influenza vaccines. The five-year agreement includes acceleration of vaccine development, creation of a manufacturing process designed to produce the vaccine in large quantities and preparation of a comprehensive feasibility plan for establishing a cell-culture vaccine manufacturing facility in the United States. -=- Name Design CURIS INC. Curis Inc. said Genentech Inc. filed an Investigational New Drug application with the Food and Drug Administration to begin human clinical studies of their investigational drug candidate for the topical treatment of basal cell carcinoma. The drug, which was discovered by Curis and is being co-developed with Genentech, is an antagonist of the Hedgehog signaling pathway. "Preclinical research has suggested that the Hedgehog antagonists have the potential to selectively kill tumor cells while not harming adjacent normal cells," said Dr. Lee Rubin, Curis' chief scientific officer. Curis and Genentech's 2003 collaboration agreement for technologies based on the Hedgehog pathway inhibitors included a co-development option, which Curis exercised in January 2005. The co-development option, under which Curis may pay an equal share of development costs and share in a commensurate portion of the profits, only applies to the U.S. marketplace. -=- Name Design ANORMED INC. AnorMED Inc. said it filed an Investigational New Drug application with the Food and Drug Administration to initiate clinical trials for AMD3100, a stem cell mobilizer, in cardiac patients. The drug candidate is currently in a Phase III trial for stem cell transplant in cancer patients. AnorMED cited preclinical results that showed AMD3100 to have therapeutic potential in tissue repair indications such as heart attack. The company hopes to begin a study later this year evaluating the safety of the drug in patients who have recently suffered heart attacks. -=- Name Design THE CENTERS FOR MEDICARE & MEDICAID SERVICES The Centers for Medicare & Medicaid Services will increase Medicare Part B premiums in 2006 to an estimated $89.20 per month, according to a letter from Medicare obtained by The Wall Street Journal. This year, the premium is $78.20, and, as reported previously, Medicare officials expected the 2006 premium would be approximately $87.70. Increased use of services and spending on physician office visits as well as higher charges for administration of chemotherapy drugs are cited as reasons for the premium increase. -=- Name Design
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