Naming Strategy - Brand Institute, inc.



			Naming Strategy 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 Avelox approved for treating complicated intra-abdominal infections in adults The Food and Drug Administration approved a sixth indication for Avelox (moxifloxacin hydrochloride), a fluoroquinolone antibiotic developed by Bayer Pharmaceuticals Corp. and marketed in the United States by Schering-Plough Corp. Avelox may now be used to treat complicated intra-abdominal infections (cIAI) in adults; Schering-Plough said this drug is the only fluoroquinolone antibiotic approved as a monotherapy for this indication. Leakage of bacteria from the gastrointestinal tract into adjacent tissue leads to these infections. The approval was based on trials in patients with cIAI. In one double-blind trial, the efficacy of sequential intravenous or oral 400 mg Avelox monotherapy once each day for five to 14 days was compared with Wyeth's intravenous Zosyn (piperacillin sodium/tazobactam sodium) four times daily followed by oral amoxicillin/clavulanate potassium twice daily for treating cIAI, including peritonitis, abscesses, appendicitis with perforation and bowel perforation. In the 379 evaluable patients, the overall success rates were 79.8 percent with Avelox and 78.1 percent with the comparator regimen. Avelox was also effective at eradicating the common pathogens of Escherichia coli and the anaerobe Bacteroides fragilis. Avelox is already approved to treat acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, community acquired pneumonia and complicated and uncomplicated skin and skin structure infections. Naming Strategy Labopharm submits NDA for once-daily tramadol Labopharm Inc. submitted a New Drug Application to the Food and Drug Administration for its once-daily formulation of the analgesic tramadol to manage moderate to moderately severe pain. The NDA is supported by data from 11 pharmacokinetic studies and five Phase III studies, including two placebo-controlled studies, one study with an active comparator and two long-term safety studies. The combined studies involved nearly 2,000 patients. The compound previously demonstrated significant improvement in a Phase III trial, as measured by the change in the Western Ontario and McMaster University Osteoarthritis Index pain and function subscales, along with the patient's global assessment, Labopharm said. The firm added that the once-daily formulation provided 24-hour relief while exhibiting a safety profile superior to that of Ortho-McNeil Inc.'s immediate-release Ultram (tramadol hydrochloride) in the study. "During discussions with the FDA, we were informed that our existing clinical package is sufficient for our NDA to be accepted for review and considered for approval," said James Howard-Tripp, Labopharm's chief executive officer. "Although previously the FDA had indicated that our submission would require an additional positive Phase III study, that is no longer the case." With Labopharm's third Phase III efficacy trial deemed unnecessary, the company expanded the trial's enrollment to improve the power of the study to achieve a better marketing position, pending approval of the drug. If approved, the drug will be co-marketed by Purdue Pharma Products L.P. Naming Strategy J&JPRD seeks FDA approval of investigational schizophrenia drug Johnson & Johnson Pharmaceutical Research & Development LLC filed a New Drug Application with the Food and Drug Administration for paliperidone extended-release, its investigational once-daily, oral treatment for schizophrenia. The submission was based on a global clinical development program that included more than 1,600 patients in 23 countries. J&JPRD said it expects to seek regulatory approval for paliperidone ER in other countries as well. Paliperidone ER uses patented OROS technology, which steadily releases the drug into the bloodstream during a 24-hour period. Janssen L.P. will market the drug in the United States. A trade name for the marketed product has yet to be determined. Naming Strategy Roche licenses autoimmune compound from BioCryst; BioCryst shares jump F. Hoffmann-La Roche Ltd. obtained an exclusive license to develop and commercialize BioCryst Pharmaceuticals Inc.'s BCX-4208 for the prevention of acute rejection in transplantation and the treatment of autoimmune diseases, sending shares of BioCryst up 37.5 percent. BCX-4208 is a transition-state purine nucleoside phosphorylase (PNP) inhibitor. Currently being studied in Phase I trials, it is believed to be able to potently modulate T-cell activity. In exchange for worldwide rights to BCX-4208, Roche will pay BioCryst $25 million in an up-front payment and $5 million to reimburse for supply of material during the first 24 months of the collaboration. Along with royalties on potential product sales of BCX-4208, BioCryst could also receive future event payments of up to $530 million. "This collaboration not only produces a substantial strategic and economic benefit to BioCryst, it also provides all of the essential elements for the rapid, comprehensive and competitive development of BCX-4208," title="branding company" said Charles Bugg, chief executive officer of BioCryst. Roche will have a right of first negotiation on existing back-up PNP inhibitors in transplant rejection or autoimmune diseases for five years, while BioCryst retains the right to co-promote BCX-4208 in the United States for several indications. BioCryst also retains all rights to any other PNP inhibitors discovered subsequent to this agreement. BioCryst licensed BCX-4208 and other PNP inhibitors from Albert Einstein College of Medicine and Industrial Research Ltd. Shares of BioCryst closed at $16.24, up $4.43, in heavy trading on the Nasdaq. Naming Strategy Discovery Partners, Pfizer end collaboration discussions; Discovery to close most of San Francisco facility Discovery Partners International Inc. and Pfizer Inc. ended their discussions regarding a potential new collaboration to replace their existing agreement set to expire Jan. 5. In the new agreement, Discovery would have provided pharmaceutically relevant chemical compounds and hit follow-up libraries for sole use by Pfizer. Due to the impending expiration of the current collaboration and the absence of a new one, Discovery expects to have less need for combinatorial chemistry and library synthesis capacity. Thus, it will consolidate its chemistry platform into its San Diego facility and close all but the compound management operations at its San Francisco facility during the first quarter of 2006. All employees not associated with the compound management operations at that facility will be relocated or terminated, the company said. According to The Associated Press, Michael Venuti, Discovery's acting chief executive officer, said he will not know how many of the plant's 50 employees will be laid off until relocation discussions are complete. Between 2002 and 2005, the contract with Pfizer provided approximately $92 million in revenue to Discovery, including $2.9 million during the fourth quarter of this year. However, due to the Discovery's decision to restructure and cease commercialization efforts related to Micro Arrayed Compound Screening, the firm will incur up to $10 million in charges during the fourth quarter of 2005 and the first half of next year. Discovery also said it will review its entire organization as it works to enhance its capabilities for drug discovery collaborations that will produce higher-value preclinical compounds. Discovery shares closed at $2.35, down $0.26, or 10 percent, in heavy trading on the Nasdaq, while Pfizer shares closed at $21.20, down $0.27, or 1.3 percent, in moderate trading on the New York Stock Exchange. Naming Strategy AzaSite, tobramycin comparable in resolving bacterial conjunctivitis, study shows InSite Vision Inc.'s AzaSite (azithromycin 1%) was shown to be equivalent to tobramycin in resolving bacterial conjunctivitis, commonly known as pink eye, in a Phase III trial. The double-blind trial included 746 patients aged 1 to 93 years with presumed bacterial conjunctivitis. A conjunctival culture was taken to demonstrate bacterial infection; 316 of the patients had positive cultures. The patients were randomized to receive AzaSite twice daily for the first two days followed by AzaSite once daily for the next three days or tobramycin 0.3% ophthalmic solution four times per day for five days. The rate of clinical resolution with AzaSite and tobramycin was considered equivalent, which was the primary efficacy endpoint (80 percent vs. 78 percent, respectively). The treatment arms also showed equivalent rates of bacterial eradication. InSite Vision said it is preparing to file a New Drug Application to the Food and Drug Administration for AzaSite next year. The product contains azithromycin that is formulated with the company's DuraSite drug delivery system. On its Web site, the firm says such a formulation allows for prolonged release and extended residence time of azithromycin in the eye, which could allow for a low-dose regimen of the product. Naming Strategy Naming Strategy Genentech Inc. Genentech Inc. entered into a research and development agreement with Piramed Ltd. to develop a new class of cancer drugs, which will target a key enzyme involved in various cancers. Under terms of the agreement, Piramed will receive an up-front payment and may receive milestone payments during development and upon product approval of up to approximately $230 million. Furthermore, Piramed will receive research funding and royalties on potential product sales. Genentech will be responsible for clinical development, regulatory approvals, manufacturing and commercialization. Piramed has the option to commercialize certain products outside of the United States. Naming Strategy Naming Strategy SkyePharma Plc SkyePharma Plc has "attracted interest" from AstraZeneca Plc, Novartis AG and Merck & Co. Inc. during the company's search for potential buyers, The Wall Street Journal reported. In addition to these pharmaceutical behemoths, rival drug-delivery companies BioValve Technologies Inc. and Endo Pharmaceuticals Inc., along with smaller pharmaceutical companies in Germany and the United States, are "circling a potential purchase" of the firm. While SkyePharma's market value is approximately $525 million, takeover bids are likely to come at a premium to that value, according to The Journal. When asked to comment on the matter, officials at AstraZeneca and Merck declined and Novartis, BioValve and Endo did not respond, The Journal reported. Naming Strategy Naming Strategy Molecular Biologics Inc. Molecular Biologics Inc. signed a consent decree, which requires the company to cease manufacturing and distributing its over-the-counter drugs until it corrects manufacturing problems at a California facility. The Food and Drug Administration said the firm is manufacturing drugs that do not follow current good manufacturing practice requirements and lacks manufacturing controls that ensure eye drops are sterile. In addition, some pain drugs lack proper warnings for safe use. MBI's product line includes eye drops sold as Oxydrops, Bright Eyes, Bright Eyes II, Clarity Vision for Life, Visitein and Can-C as well as the OTC pain relievers sold as Biogesic, Bio-Ice and Bio-Heat. MBI President Ned Jensen told The Wall Street Journal they are addressing the FDA's concerns and will be building a separate room in a new facility in order to resume manufacturing of the eye drops. Naming Strategy Naming Strategy Apotex Corp. Apotex Corp. received final approval from the Food and Drug Administration to market ofloxacin otic 0.3%, the generic equivalent of Daiichi Pharmaceutical Corp.'s Floxin, an ear infection solution. Because Apotex was the first to file the Abbreviated New Drug Application, it will receive 180 days of market exclusivity. Shipments of the drug will begin once ongoing litigation has been successfully completed. Daiichi initiated a lawsuit against Apotex in 2003. The bench trial has ended, but the district court entered an order preventing Apotex or Daiichi from launching a generic version of Floxin until a final judgment is entered. Naming Strategy


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