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NamingBrand 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 ROCHE CEASES DEVELOPMENT OF TWO ALZHEIMER'S DISEASE TREATMENTS LICENSED FROM MEMORY PHARMACEUTICALSMemory Pharmaceuticals Corp. said Friday that F. Hoffman-La Roche Ltd. will not pursue further development of two investigational Alzheimer's disease treatments on its own. The two companies are discussing the future of these PDE4 inhibitors, known as MEM 1414 and MEM 1917, and will continue to collaborate on Memory's PDE4 inhibitor back-up compounds, according to Memory. Roche might not stop the development of MEM 1414 and MEM 1917 if "it can find a partner," The Wall Street Journal reported. In 2002, Roche acquired exclusive worldwide rights to any candidate from Memory's PDE4 program. In 2003, the companies expanded their strategic alliance to develop candidates for the treatment of Alzheimer's disease and schizophrenia. Under this agreement, Roche purchased a minority stake in Memory. At the time, the firms said Memory could get up to $150 million in payments plus royalties. Under an August 2004 extension of the agreement, Roche committed $5.25 million to fund 18 months of Memory's PDE4 research efforts. Memory's most advanced compound, MEM 1003, is also being evaluated as an Alzheimer's disease treatment and was licensed from Bayer AG, The Journal stated. Memory's stock closed at $2.72, down $1.32, or 32.7 percent, in moderate trading on the Nasdaq. -=- INTERIM ANALYSIS SHOWS GENENTECH, ROCHE'S AVASTIN MET ENDPOINT OF IMPROVING PROGRESSION-FREE SURVIVAL IN PATIENTS WITH BREAST CANCER An interim analysis of Genentech Inc. and F. Hoffman-La Roche Ltd.'s Phase III study of Avastin (bevacizumab) plus paclitaxel chemotherapy revealed that the drug met its primary endpoint of improving progression-free survival in patients with breast cancer. In the trial, which was sponsored by the National Cancer Institute, 722 patients with previously untreated breast cancer that had spread to other areas of the body were randomized to receive either Avastin plus paclitaxel or paclitaxel alone. Avastin works to cut off the blood supplied to tumors, inhibiting their growth, The Wall Street Journal reported. The analysis showed the drug could prolong the period during which advanced breast cancer does not progress. Analysts from JPMorgan said the increase could be from six months with paclitaxel alone to as much as eight months with Avastin plus paclitaxel, The Associated Press reported. As a result of the positive outcome of the analysis, the companies said they plan to discuss an expanded indication for Avastin as a first-line breast cancer treatment with the Food and Drug Administration. In February 2004, the FDA approved the drug to be used with intravenous 5-FU-based chemotherapy as a first-line treatment for metastatic colorectal cancer, and an independent study last month found it was effective in the treatment of non-small cell lung cancer, The Journal reported. Market analysts say if the results of the interim analysis are confirmed, Avastin could increase its annual sales to more than $8.24 billion, The Journal stated. On Friday, shares of Genentech closed at $69.35, up $10.72, or 18.3 percent, in heavy trading on the New York Stock Exchange. -=- AVANIR'S NEURODEX MAY IMPROVE CONDITION OF PATIENTS WITH MS WITH PSEUDOBULBAR AFFECT, RESEARCH REVEALS Avanir Pharmaceuticals' Neurodex (dextromethorphan/quinidine) may improve the condition of multiple sclerosis patients with pseudobulbar affect (PBA), according to research presented at the 2005 Annual Meeting of the American Academy of Neurology in Miami. In a randomized, double-blind study, 150 patients with MS and PBA received either placebo or Neurodex on a 12-hour dosing schedule for 90 days. The study participants used a diary to track the number of laughing/crying episodes they experienced each day. According to Dr. Hillel Panitch, one the study's investigators and professor of neurology at the University of Vermont College of Medicine, 84 percent of Neurodex-treated patients reported that their condition improved while only 49 percent of placebo-treated patients reported improvement. Also, Dr. Panitch stated that patients treated with Neurodex reported 46 percent fewer laughing and/or crying episodes than those given placebo. Researchers also found that Neurodex-treated patients reported overall improvement in the amount of pain they experienced, their quality of life and the quality of their relationships. PBA--a disinhibition syndrome of the motor expression of emotion--involves "uncontrollable laughing or crying in a manner that is out of context to the basic social setting," according to Avanir. Patients with various neurological conditions, such as Alzheimer's disease and stroke, can be affected by PBA. Avanir said it completed Phase III trials of Neurodex for the treatment of PBA and is submitting a New Drug Application to the Food and Drug Administration on a rolling basis. The company expects to complete submission in the first half of this year, at which time the FDA will grant the NDA priority review status. If approved, Neurodex would be the first drug indicated to treat PBA, Avanir said. According to an IMS Health market survey commissioned by the company, the potential market for PBA drugs is estimated to be approximately $500 million in 2006, which could be Neurodex's first year on the market. Avanir also intends to start a Phase III trial of Neurodex as a treatment for diabetic neuropathic pain in mid-2005 under a special protocol assessment granted by the FDA in January. IriSys Inc. sublicensed Neurodex to Avanir in 2000. Avanir shares closed at $2.64, up $0.12, or 4.8 percent, in heavy trading on the American Stock Exchange. -=- TWO ANALYSES FIND FOREST LAB'S CAMPRAL SAFE, WELL TOLERATED FOR TREATMENT OF ALCOHOL DEPENDENCE Two analyses of multiple studies with Forest Laboratories Inc.'s Campral (acamprosate calcium) delayed-release tablets found the drug to be safe and well tolerated for the long-term treatment of alcohol dependence. The results of the analyses were presented at the 36th Annual Medical Scientific Conference of the American Society of Addiction Medicine in Dallas. "These data are important because they show that Campral is safe for alcohol-dependent patients and even in those who may be taking other medications," said Richard Rosenthal, one of the investigators and a professor of clinical psychiatry at Columbia University's College of Physicians and Surgeons. "Unlike older treatments for alcohol dependence, Campral is not metabolized through the liver. Its favorable long-term safety profile makes it an attractive new option to help reduce relapse in patients committed to staying abstinent from alcohol." One analysis examined five year-long, double-blind studies with 1,681 patients aged 16 to 70 years. Patients were randomized to receive either Campral 1,332 mg/day or Campral 1,998 mg/d plus counseling or placebo plus counseling. The second analysis looked at four long-term and six short-term trials to determine the tolerability of other drugs taken in conjunction with Campral versus placebo. In both analyses, patients taking Campral reported similar adverse events compared with patients receiving placebo. In clinical trials, the most frequently reported side-effect was diarrhea. The 1,998 mg/d dose of Campral is approved by the FDA to maintain abstinence of alcohol in patients who are abstinent when treatment begins. Merck Sante sas, a subsidiary of Merck KGaA, developed Campral and licensed the drug to Forest in the United States. -=- FDA SENDS WARNING LETTERS REGARDING ADS FOR PFIZER'S ZYRTEC, BAYER'S LEVITRA; AGENCY ASKS COMPANIES TO PULL ADS The Food and Drug Administration sent a warning letter to Pfizer Inc. regarding direct-to-consumer (DTC) print advertisements for its allergy drug, Zyrtec (cetirizine hydrochloride). According to the letter, the advertisements--titled "Tired of your allergy medicine not working?" and "Maybe it's time to switch allergy medicines"--make unsubstantiated "superiority claims about Zyrtec by suggesting it is clinically superior to some other allergy medicines." Specifically, the agency disapproved of claims "that Zyrtec 'works' and that at least some other allergy medicines do not work." The FDA also sent a letter to Bayer AG regarding a DTC television advertisement for its erectile dysfunction drug, Levitra (vardenafil hydrochloride). According to this letter, the advertisement--titled "My Man"--"fails to disclose the drug's indication, fails to include information relating to the major side effects and contraindications and fails to make adequate provision for dissemination of the FDA-approved labeling." The agency added that, contrary to clinical evidence, the advertisement "contains representations or suggestions that Levitra is superior to other erectile dysfunction treatments." In the United States, Levitra is co-marketed by GlaxoSmithKline Plc and Bayer through its distributor, Schering-Plough Corp. The FDA asked both Pfizer and Bayer to pull the ads in question and submit a written response by April 27. -=- LOW MORTALITY RATES ASSOCIATED WITH INTENTIONAL OVERDOSES OF SECOND-GENERATION AEDS SUPPORT CURRENT EVIDENCE SUGGESTING FAVORABLE SAFETY PROFILES Among patients taking second-generation antiepileptic drugs (AEDs), the low mortality rate associated with non-accidental overdoses provides further evidence of the favorable safety profiles attributed to these drugs, according to the authors of a retrospective study published in the April issue of the journal Seizure. Using the National Poisons Information Center (NPIC) and the Central Statistics Office (CSO) in Ireland, researchers with Beaumont Hospital in Dublin identified 164 cases of non-accidental overdose with second-generation AEDs occurring from 1996 through 2000 (gabapentin, n=33; GlaxoSmithKline Plc's Lamictal [lamotrigine], n=97; UCB Pharma Inc.'s Keppra [levetiracetam], n=1; Novartis AG's Trileptal [oxcarbazepine], n=0; Cephalon Inc.'s Gabitril [tiagabine hydrochloride], n=5; topiramate, n=7; vigabatrin, n=21). Vigabatrin has not been approved by the Food and Drug Administration for use in the United States; the drug is marketed by sanofi-aventis Group in most other countries under the brand name Sabril. Of the 164 overdoses, no mortalities were associated with deliberate self-poisoning. The authors also reviewed the NPIC database to ascertain cases of non-accidental overdoses with older AEDs during the same period (n=320). However, the mortality rate could only be evaluated in 26 patients treated at Beaumont Hospital. There were no fatalities among these patients; however, five of them required a prolonged hospital admission (at least one week), which the authors suggested could signify more serious consequences from drug toxicity. They also cited published case reports of fatalities with several first-generation AEDs. "This contrasts with the paucity of fatalities from the newer AEDs," they added. "Given the high incidence of impulsive suicidal gestures reported among patients with epilepsy, especially partial epilepsy, as well as the high prevalence of depression, the newer generation AEDs may confer an additional advantage in prescribing," the authors concluded. "The absence of serious consequences from deliberate self-poisoning of these agents in our study is supportive evidence for their superior safety profile in normal prescribing but also in the management and prevention of fatality from the significant risk of non-accidental overdose of AEDs in individuals with epilepsy." -=- Naming F. HOFFMAN-LA ROCHE LTD. F. Hoffman-La Roche Ltd. launched its public clinical trial registry and results database that will allow online access to clinical trial information without password restrictions. The Web site will be maintained by independent host CenterWatch, which is owned by Canada's Thomson Corp. Roche said it will take up to one year until all data from global and local trials of more than 30 drugs will be published on the site. The site will eventually include results from Phase II to Phase IV clinical trials completed after Oct. 1, 2004; retrospective results of Phase II to Phase IV clinical trials for drugs marketed after Oct. 1, 2002; and interventional clinical studies from Roche's diagnostics division, The Wall Street Journal reported. -=- Naming ORTEC INTERNATIONAL INC. Ortec International Inc. received notice that the Food and Drug Administration now has all of the information it needs to review and give a recommendation for Ortec's Pre-Market Approval application for OrCel (bilayered cellular matrix) to treat venous ulcers. The company will not be required to meet with the FDA this month regarding the application as previously announced. The FDA is expected to give its recommendation within 30 days. -=- Naming CRUCELL NV Crucell NV, a Dutch biotechnology company, signed an agreement with the U.S. Vaccine Research Center to create Ebola virus vaccines. Crucell will receive approximately $27.6 million to produce up to 10 batches of the vaccine. The company will use its PER.C6 gene technology, which produces drugs by way of a human cell platform, and will make vaccines available for human clinical studies, Reuters reported. Researchers also hope to use the technology to make vaccines against HIV and cancer. -=- Naming SCHWARZ PHARMA AG Schwarz Pharma AG, a German drug company, will apply for marketing approval of its festerodine overactive bladder treatment in Europe and the United States. The announcement came after Phase III trials showed positive results in approximately 1,900 patients with an overactive bladder. Sales of the drug are expected to peak at $576.8 million. The application could be filed as early as the first quarter of 2006, Reuters reported. -=- Naming
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