Your Company Name - Brand Institute, inc.



			Your 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 FDA delays ruling on Cephalon, Alkermes' Vivitrex for alcohol dependence The Food and Drug Administration delayed by three months the deadline to rule on Cephalon Inc. and Alkermes Inc.'s New Drug Application for Vivitrex (naltrexone long-acting injection) for the treatment of alcohol dependence. The original action date for the priority review was Sept. 30 but was extended to Dec. 30 because a recent response by Alkermes was considered by the agency to be a major amendment to the application. Such an amendment permits the FDA to extend the action date by 90 days under Prescription Drug User Fee Act regulations, the companies said. Despite the delay, Cephalon and Alkermes still plan to launch Vivitrex during the first half of 2006. "We will continue to work closely with the FDA to assist them in the completion of the review of the application in a timely manner," Alkermes Chief Executive Officer Richard Pops said. "This extension does not affect our plans for the timing of the commercial launch of Vivitrex." Data from a Phase III study that included 624 adults with a current diagnosis of alcohol dependence showed that patients who received Vivitrex experienced a reduction in the median number of heavy drinking days from 19 days per month to three days per month. The subjects had been randomized to receive once-monthly injections of Vivitrex 380 mg, Vivitrex 190 mg or placebo for six months in addition to psychosocial counseling during the treatment period. Heavy drinking was defined as five or more drinks per day on a regular basis for men and four or more drinks for women. Vivitrex was also found to be well tolerated, with predominantly mild adverse events that decreased over time. Alkermes shares closed at $17.00, down $1.67, or 8.9 percent, in heavy trading on the Nasdaq, while Cephalon shares closed at $45.55, down $0.76, or 1.6 percent, in light trading on the Nasdaq. Your Company Name Alnylam stops development of AMD product, shifts to RSV product Alnylam Pharmaceuticals Inc. is suspending further development of ALN-VEG01, its RNAi therapeutic candidate targeting vascular endothelial growth factor (VEGF) for age-related macular degeneration due to increased competition. The development of ALN-VEG01 was part of Alnylam and Merck & Co. Inc.'s ocular collaboration. Alnylam said the companies will continue to work together on the discovery of other RNAi therapeutics for the treatment of ocular disease. The company plans to shifts its focus to its proprietary RNAi therapeutic candidate for respiratory syncytial virus (RSV) infection, ALN-RSV01. Alnylam expects to file an Investigational New Drug Application with the Food and Drug Administration for ALN-RSV01 by the end of the year. The company previously planned to submit the INDA in the first half of 2006. "There exists a significant unmet medical need for novel therapies to effectively treat patients infected with RSV, and we are pleased to report that, based on the tremendous progress we have made with this proprietary program, we are able to move our therapeutic candidate into human clinic trials ahead of schedule. Based on our interactions with regulatory authorities, we believe we have a clear path forward to conduct a Phase I safety study," said John Maraganore, chief executive officer of Alnylam. The company continues to report that it will end the year with more than $75 million in cash and is on track to announce its third development program by the end of the year. Eyetech Pharmaceutical Inc. and Pfizer Inc. already sell Macugen (pegaptanib sodium), the leading therapy for AMD. In July, one-year trial data showed Genentech Inc. and Novartis Ophthalmics Business Unit's Lucentis (ranibizumab) maintained vision in patients with AMD during a Phase III trial. Your Company Name QLT's Visudyne in Occult trial did not achieve primary endpoint A preliminary analysis of the intent-to-treat population in QLT Inc.'s Visudyne (verteporfin) in Occult (VIO) trial showed the study did not achieve the primary endpoint at the two-year mark, according to a QLT press release. The Phase III, double-masked, randomized trial was designed to determine if Visudyne in combination with photodynamic therapy could reduce the risk of vision loss in patients with wet age-related macular degeneration who had subfoveal occult with no classic choroidal neovascularization (CNV). The trial is one of a series of trials conducted with Visudyne in patients with predominantly occult CNV. Evidence of efficacy was demonstrated in this patient population in two previous trials, Visudyne in Photodynamic Therapy (VIP) and Visudyne in Minimally Classic (VIM). The full efficacy results and safety analyses, together with evidence from the three trials, will be reviewed at the data and safety monitoring committee meeting and in advisory boards. Visudyne therapy, a two-step procedure administered intravenously, is the only drug currently approved for the treatment of a form of wet AMD, according to QLT. The company said it will continue to conduct further analyses on relevant subgroups. Visudyne is marketed by Novartis Ophthalmics. QLT shares closed at $7.22, down $1.09, or 13.1 percent, in heavy trading on the Nasdaq. Your Company Name Albany Molecular, Aventis seek to block generic sales of Allegra Albany Molecular Research Inc. (AMRI) and sanofi-aventis Group's subsidiary Aventis Pharmaceuticals Inc. are seeking to block a number of drug companies from selling generic versions of the allergy drug Allegra (fexofenadine hydrochloride) ahead of court rulings on the validity of certain Allegra patents. The companies asked a federal court for a preliminary injunction to block sales of generic versions in response to Barr Pharmaceuticals Inc. and Teva Pharmaceutical Industries Ltd.'s announcement earlier this month that they have entered into an agreement to launch generic versions of the tablets ahead of a patent ruling, AMRI said in a press release. Other companies AMRI and Aventis seek to enjoin include Ranbaxy Laboratories Ltd. and Amino Chemicals Ltd. Aventis filed Allegra-related patent infringement actions beginning in 2001. In 2004, AMRI joined Aventis in filing additional lawsuits pertaining to AMRI's fexofenadine-related patents, which it said are licensed to Aventis. In a statement, Barr Chief Executive Officer Bruce Downey said the company intends to "vigorously oppose this effort." Allegra sales were $1.4 billion for the 12 months ended in June, according to IMS Health Inc. data, The Associated Press reported. Your Company Name New Web site to provide trial data for patients, physicians Pharmaceutical companies worldwide launched a new Web site to provide details of clinical trials on new drugs. The Web site was developed in response to criticism that companies manipulate or suppress results of clinical studies in order to report favorable outcomes, Reuters reported. The site, www.ifpma.org/clinicaltrials.html, was established by the International Federation of Pharmaceutical Manufacturers & Associations. The Clinical Trials Portal will provide online access to detailed information about most new clinical trials. However, companies do have the option to withhold some information, according to Reuters. For example, Phase I studies on healthy volunteers are exempt. Also, there is no obligation to reveal the results of studies before a drug is approved. Trial results should be available on the Web site within one year of a drug's approval, or, for trials on drugs that have already been approved, within one year of the trial being completed. The new site was a significant step forward in transparency, allowing physicians and patients to carry out searches in particular areas quickly and easily, Richard Barker, director general of the Association of the British Pharmaceutical Industry, told Reuters. The Web site has the backing of major pharmaceutical groups such as GlaxoSmithKline Plc, Pfizer Inc., AstraZeneca Plc, Merck & Co. Inc., Novartis AG and sanofi-aventis Group, Reuters added. Your Company Name Funding for biomedical research doubled during past decade; greater scrutiny needed for how to best spend money, study suggests Data from a new study that examined funding trends for biomedical research showed a significant increase from 1994, when $37.1 billion was spent, to 2003, when spending was $94.3 billion. Taking inflation into account, biomedical research funding doubled during the decade evaluated. However, the authors of the study noted that greater scrutiny is needed as to how best to use these research dollars. "[T]he growth in total spending obscures some changes in how that money is spent," the researchers indicated. Using both publicly available information as well as subscription-based proprietary databases, the investigators determined total actual research spending, growth rates and the type of research to which funding was allocated. In 2003, 57 percent of the biomedical research was sponsored by industry while the National Institutes of Health funded 28 percent; these proportions did not change during the course of the decade examined. In terms of funds devoted to basic versus applied research, the proportion of federal funding to each did not change, although industry sponsorship of clinical trials increased substantially from $4 billion to $14.2 billion. The study authors suggested that this is due, in part, to the growing length and complexity of the clinical trials process as well as other factors that have increased pharmaceutical companies' research costs. Biomedical research comprised 5.6 percent of total U.S. health expenditures, yet less than 0.1 percent was spent on health services research. The investigators called this finding "especially notable" since health services research is the main tool available to evaluate the clinical benefit of technology. Research productivity could be enhanced by more effectively translating basic scientific knowledge to clinical application and by focusing investment on areas where the clinical need is the greatest, not on only perceived commercial opportunity, the study authors suggested. "Responsibility falls on industry, government and foundations to bring these changes about with a longer-term view of research value," they concluded. The study was published in the Sept. 21 issue of JAMA. Your Company Name Your Company Name GlaxoSmithKline Plc GlaxoSmithKline Plc will pay $149 million plus approximately $1.8 million in interest to the U.S. government to settle allegations related to pricing of the company's drugs Zofran (ondansetron hydrochloride) and Kytril (granisetron hydrochloride), which are used for the treatment of chemotherapy- or radiation-induced nausea. According to the federal government, GSK artificially inflated prices of the two drugs for the Medicare and Medicaid programs, but charged health care providers less for the drugs, knowing that providers would keep the difference, Dow Jones Newswires reported. As part of the settlement, GSK admitted no wrongdoing, but instead "decided to settle the case . . . to put this historical matter behind it," according to a company statement. Your Company Name Your Company Name sanofi-aventis Group Sanofi-aventis Group's vaccine Hexavac was recommended for suspension by the European Medicines Agency because of concerns it may not offer adequate protection against hepatitis B. The vaccine is designed to protect infants and children against diphtheria, tetanus, pertussis, hepatitis B, polio and Haemophilus influenzae type B. Variability in the production process of the hepatitis B component may result in "decreased long-term protection against hepatitis B," experts at the EMEA concluded. Reuters reported this component is manufactured by Merck & Co. Inc. Hexavac represents approximately 10 percent of sanofi-aventis' vaccine sales. Your Company Name Your Company Name Medicure Inc. Medicure Inc.'s investigational cardioprotective drug MC-1 received fast track designation from the Food and Drug Administration as a treatment to reduce cardiovascular and cerebrovascular events related to ischemia and/or ischemic reperfusion injury among patients who experience percutaneous coronary interventions, coronary artery bypass graft surgery or acute coronary syndrome. MC-1 is a naturally occurring small molecule that reduces the amount of damage to the heart following ischemia and/or ischemic reperfusion injury by apparently protecting heart muscle cells, which do not regenerate themselves following an ischemic event. Results of a Phase II/III trial of MC-1 in patients undergoing coronary artery bypass graft surgery are expected this fall. Medicure shares closed at $1.01, up $0.09, or 9.6 percent, in heavy trading on the New York Stock Exchange. Your Company Name Your Company Name Abmaxis Inc. Abmaxis Inc. and MaimoniDex RA Ltd. signed an agreement to jointly develop a treatment for rheumatoid arthritis and other inflammatory diseases. Abmaxis plans to humanize a mouse monoclonal antibody that MaimoniDex developed that has shown bioactivities both in vitro and in vivo. While specific financial details of the arrangement were not disclosed, the agreement does call for MaimoniDex to pay an up-front technology license fee to Abmaxis, which also is entitled to future milestone payments and royalties on product sales. Your Company Name Your Company Name


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