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Registering Company NameBrand 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 GSK's Relenza for prevention of flu The Food and Drug Administration approved the use of GlaxoSmithKline Plc's Relenza (zanamivir) inhalation to prevent influenza in patients aged 5 years or older.The antiviral treatment was already approved to treat influenza A and B virus infections in adults and children. Relenza is now the second product after Roche's Tamiflu (oseltamivir phosphate) to be approved for prevention of the flu. The new approval was based on four studies that compared the effectiveness of Relenza with that of placebo in preventing seasonal flu, according to the FDA. In two of the trials, use of the drug reduced the spread of flu as compared with placebo. Specifically, 19 percent of households in the placebo groups developed flu symptoms compared with 4.1 percent of households in the Relenza groups. The other two trials were conducted in communities in the midst of a flu outbreak. In one of the studies, which included participants aged 18 years or older, 6.1 percent of the placebo group developed flu symptoms, while 2 percent of the Relenza group did so. In the second study, which included people aged 12 to 94 years, 1.4 percent of participants in the placebo group developed flu symptoms compared with 0.2 percent of those in the Relenza group. The FDA noted that drug has not been shown to be effective to treat flu in people with underlying airway disease or to prevent flu in nursing homes. In addition, the agency said Relenza should not be used in lieu of the flu vaccine. Registering Company Name Novartis expands pipeline, licenses hepatitis C drug for up to $525 million Novartis AG entered into agreements with various companies to license the rights to new drugs, including a hepatitis C drug for up to $525 million. Novartis exercised its option to license Idenix Pharmaceuticals Inc.'s valopicitabine (NM283), an oral antiviral in development for the treatment of hepatitis C. Valopicitabine, which blocks hepatitis C virus replication by specifically inhibiting the HCV RNA polymerase, is being evaluated in ongoing clinical trials. Under the terms of the agreement, Idenix may receive up to $70 million in license fees, $25 million of which was paid in conjunction with exercising the option. Novartis will pay Idenix the remaining $45 million in license fees once valopicitabine advances into Phase III clinical trials. Additionally, Idenix may receive up to $455 million in milestone payments upon achievement of regulatory filings and marketing authorization approvals of valopicitabine in the United States, as well as the European Union and Japan. Novartis will reimburse expenses associated with the development of valopicitabine that Idenix incurs after the date of license. If the drug is successfully developed, Idenix and Novartis will co-promote valopicitabine in the United States and the major European markets. Novartis will have exclusive rights to market and promote valopicitabine in the rest of the world. Separately, Novartis signed an agreement with French pharmaceutical company Servier to license agomelatine, a drug currently in Phase III trials that is designed to treat major depressive disorder. Agomelatine is a melatonergic antidepressant that acts as an agonist at MT1 and MT2 receptors with additional 5-HT2c antagonist properties. Under the terms of the agreement, Novartis acquired the exclusive rights to further develop and market the drug in the United States and several other countries. Financial terms of the agreement were not disclosed. Earlier this week, Novartis entered into an agreement with SGX Pharmaceuticals Inc. for the development and commercialization of treatments for drug-resistant chronic myelogenous leukemia. Novartis' total payments to SGX, excluding royalties, could reach more than $515 million, including milestone payments and at least two years of research funding. Registering Company Name GSK, Colgate-Palmolive potential buyers of Pfizer's consumer business GlaxoSmithKline Plc and Colgate-Palmolive Co. are expected to make offers for Pfizer Inc.'s consumer-products business in the first round of bidding, The Wall Street Journal reported, citing sources "familiar with the matter." In February, Pfizer said it was considering options for the consumer health care unit, including retaining, spinning off or selling it. According to The Journal, Pfizer's consumer line, which includes Listerine, Bengay pain-relieving cream, Visine eyedrops and Sudafed cold tablets, is one of the most valuable, but added that most investors view the company as more of a player in the pharmaceutical market. The Journal said Pfizer was looking for a bid of approximately $14 billion but noted that it could be months before Pfizer sorts through the offers and names a final winner. Other potential suitors mentioned by The Journal include Novartis AG and Reckitt Benckiser Plc. Separately, The Journal said Pfizer confirmed that the U.S. Attorney's office in Brooklyn is looking into the company's marketing practices for the blockbuster Lipitor (atorvastatin calcium), a cholesterol treatment. In addition, the company is reviewing a lawsuit relating to the marketing of the drug, The Journal added. Registering Company Name Guidant places Xience V stent on hold Guidant Corp. will not release inventory of its Xience V everolimus-eluting coronary stent system because the company found a small percentage of the supply "was not manufactured with strict adherence to its quality standards." The hold on the Xience V inventory has forced Guidant to stop enrolling patients in the 4.0 mm and the Japan arms of its SPIRIT III clinical trial, which is designed to evaluate the safety and efficacy of the Xience V as a treatment for coronary artery disease. The company plans to ship units to study investigators as soon as new products are available. Enrollment in the U.S. portion of the trial was completed earlier this year. Guidant will record a charge of approximately $15 million in the first quarter due to a write-off of existing Xience V inventory and will delay the European launch of the stent until the third quarter of 2006. The company said it has notified the Food and Drug Administration of the suspension, as well as Boston Scientific Corp. and Abbott. Despite Guidant's ongoing problems, Boston Scientific expects to complete its $27 billion acquisition of the company during the first week of April. Registering Company Name Axcan amends NDA for H. pylori treatment Axcan Pharma Inc. submitted an amendment to its New Drug Application for Helizide (biskalcitrate potassium/metronidazole/tetracycline hydrochloride), an experimental treatment for the eradication of Helicobacter pylori. The amendment addresses questions from the Food and Drug Administration related to manufacturing issues, although no safety or efficacy issues have been raised. In October 2003, Axcan received a second non-approvable letter for Helizide due to ongoing manufacturing deficiencies. The application was based on Phase III trials, which included 275 patients with a history of duodenal ulcer. The trials compared a widely used drug combination (20 mg of omeprazole, 1 g of amoxicillin and 500 mg of clarithromycin, all given twice daily) with a combination of a Helizide regimen (three capsules, four times per day) and two daily doses of 20 mg of omeprazole. On an intent-to-treat basis, the Helizide-treated group experienced an 88 percent eradication rate compared with 83 percent in the control group. The company noted that it could launch Helizide as early as the first half of 2007. The company is also working on filing applications in the European Union. The drug was previously known as Helicide; Axcan now intends to market it as Helizide, a company spokeswoman told Faxwatch. Registering Company Name Phase III data indicate lacosamide adjunct therapy reduces frequency of partial seizures Schwarz Pharma AG's oral lacosamide met its primary endpoints as an adjunct treatment for epilepsy in a Phase III trial. The double-blind trial was conducted among 485 patients who had refractory epilepsy: they experienced partial seizures even though they were already receiving treatment. They underwent a four-week titration phase followed by a 12-week maintenance phase and were randomized to receive additional treatment with 200 mg or 400 mg of oral lacosamide per day or placebo. The primary parameters included a reduction in seizure frequency as well as a 50 percent response to treatment, defined as at least a 50 percent reduction in seizures. Between baseline and the end of the maintenance phase, both doses of lacosamide led to statistically significant reductions in seizure frequency compared with placebo. Among the responders, the 400 mg dose of lacosamide also resulted in statistical significance for reducing seizure frequency by at least 50 percent from baseline. The most common side effects with lacosamide therapy included dizziness, nausea and vomiting. "The data from this trial confirm the results we have seen from the Phase II program," said Dr. Iris Loew-Friedrich, a member of the company's executive board. "Thus, we will ask the regulatory agencies to consider this trial to be the second pivotal trial in the marketing application for adjunctive therapy in adults with partial seizures." More than 90 percent of the trial completers have entered into an open-label, follow-up study, and another Phase III trial is under way. Schwarz Pharma is also developing an IV formulation of lacosamide and has reported positive Phase III data from a trial that employed lacosamide as a treatment for diabetic neuropathic pain. PharmaTimes.com reported that lacosamide could achieve sales of approximately $360.9 million in epilepsy. Schwarz Pharma has said the drug could achieve nearly $722 million in sales if it is approved for neuropathic pain, PharmaTimes.com added. Registering Company Name Registering Company Name Biogen Idec Inc. Biogen Idec Inc. and Elan Corp. Plc enrolled and dosed the first patients in the Tysabri (natalizumab) monotherapy safety extension study program. Patients who previously participated in the Phase III multiple sclerosis trials and subsequent safety evaluation are eligible to be screened for inclusion in the trial. Since Biogen Idec and Elan suspended the clinical trials of Tysabri based on reports of progressive multifocal leukoencephalopathy (PML), the companies have completed a comprehensive safety evaluation that yielded no new confirmed case of PML. In February, the Food and Drug Administration removed its clinical hold on Tysabri for treating MS in trials. On March 8, an FDA advisory committee voted unanimously to reintroduce Tysabri to the market as a treatment for relapsing forms of MS. Registering Company Name Registering Company Name Vertex Pharmaceuticals Inc. Vertex Pharmaceuticals Inc. entered into a research collaboration with Caprion Pharmaceuticals Inc.'s Applied BioMedicine Group. Under the agreement, Caprion will use its CellCarta proteomics platform to identify potential pharmacodymanic biomarkers in samples from studies conducted by Vertex. Registering Company Name Registering Company Name Arena Pharmaceuticals Inc. Arena Pharmaceuticals Inc. will continue development of its experimental insomnia treatment, APD125, and its investigational obesity treatment, APD356. The Food and Drug Administration requested clarification of certain nonclinical issues in its Investigational New Drug application regarding APD125. Arena believes available data may resolve the issues, but the FDA may require additional data. Regarding APD356, toxicology studies provided additional evidence of a favorable safety profile, showing that the drug has no apparent drug effect on heart valves or pulmonary vasculature. Registering Company Name Registering Company Name CuraGen Corp. CuraGen Corp. and TopoTarget A/S began patient dosing in a Phase I trial designed to evaluate the safety and tolerability of PXD101, a small molecule histone deacetylase inhibitor, in combination with Millennium Pharmaceuticals Inc.'s Velcade (bortezomib) for the treatment of patients with advanced malignancies, including solid tumors and lymphomas. Up to 46 patients will be enrolled in this trial, which is being sponsored by the National Cancer Institute. In parallel with NCI-sponsored trials, CuraGen is conducting other clinical trials of the drug, including a Phase Ib/II study in which it will be used along with Velcade as a treatment for multiple myeloma; the study began last week. Registering Company Name Registering Company Name PowderMed Ltd. PowderMed Ltd. received approval for an Investigational New Drug application for pdpSC18, its DNA vaccine for hepatitis B (HBV). The company began Phase I clinical trials, which will primarily evaluate the safety and tolerability of the dual-antigen encoding immunotherapeutic administered by PMED, PowderMed's needle-free delivery technology. The trials will study the drug in patients with chronic HBV, both as monotherapy and in combination with GlaxoSmithKline Plc's Epivir (lamivudine). Registering Company Name
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