Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: orkrious who wrote (6313)	5/11/2002 1:17:44 PM
From: Biomaven	Respond to of 52153

<amemvive> I think that reaper's response is overly pessimistic. Getting to PASI 75% is no small achievement and some present therapies have tox issues as well. On another issue, here's a rare success - a positive AC view on FRX's acamprosate, despite a US trial that failed: Friday May 10, 6:34 pm Eastern Time Press Release SOURCE: Forest Laboratories Forest Laboratories and Merck KGaA Announce Positive Outcome of FDA Advisory Committee's Review of Acamprosate Data Committee Concluded Efficacy Data Submitted Can Support Approval of Acamprosate NEW YORK, May 10 /PRNewswire-FirstCall/ -- Forest Laboratories (NYSE: FRX - News) and Merck KGaA announced today that an advisory committee to the U.S. Food and Drug Administration (FDA) concluded that clinical trial data for acamprosate demonstrates efficacy in the maintenance of abstinence for patients with chronic alcohol dependence when the medication is used in conjunction with psychosocial or behaviorial counseling. (Logo: newscom.com ) The FDA's Division of Anesthetic Critical Care and Addiction Drug Products asked its Psychopharmacology Drugs Advisory Committee to determine if submitted clinical studies provide sufficient evidence of the efficacy of acamprosate in the treatment of alcoholism to warrant approval. The FDA will now take the committee's vote into consideration as it completes the review of the New Drug Application for acamprosate. Acamprosate is currently under priority review at the Agency, and is the first new alcohol-treatment medication to reach this stage of FDA review in more than seven years. The committee reviewed data from four large, randomized, placebo- controlled studies that were submitted to the FDA as part of the acamprosate New Drug Application. Barbara Mason, Ph.D., Professor, Department of Psychiatry and Behaviorial Sciences and Director, Division of Substance Abuse, University of Miami School of Medicine, presented data to the advisory committee and explained why acamprosate could be beneficial to alcohol- dependent patients in the United States. "Acamprosate demonstrated a favorable safety and tolerability profile and a consistent ability to help motivated patients remain abstinent in clinical studies," said Lawrence Olanoff, M.D., Ph.D., Executive Vice President of Scientific Affairs for Forest Laboratories. "If approved by the FDA, Forest believes acamprosate will be a much needed new option for the alcohol- treatment community." Acamprosate, developed by Lipha S.A.S., a pharmaceutical subsidiary of Merck KGaA, based in Darmstadt, Germany, will be marketed by Forest Laboratories in the United States if the medication gains final U.S. regulatory approval. The medication has been developed for use in conjunction with psychosocial or behavioral counseling. "We are pleased by the conclusion of the FDA Advisory Committee that the clinical data for acamprosate demonstrates the medication's efficacy," said Anita M. Goodman, M.D., Lipha Project Leader for acamprosate in the United States. "This drug has been widely studied in Europe, enabling registration in 39 countries. We and Forest hope that acamprosate will soon be approved and available in the United States to help maintain abstinence in alcohol- dependent patients." Acamprosate and Alcoholism Background Acamprosate is a central nervous system-acting medication believed to help restore balance to the brain's neurotransmitter systems that are adversely affected by chronic exposure to alcohol. Researchers believe acamprosate's ability to modulate affected neurotransmitters within the brain helps people maintain abstinence. Acamprosate's mechanism of action is distinct from currently available therapies, which either block the "high" associated with alcohol or are aversive and induce vomiting if alcohol is ingested. No medication used on its own can completely eliminate the compelling power of alcohol dependence or the risk of relapse. Relapse is common among recovering alcohol-dependent patients. One in five patients in treatment facilities have been in a rehabilitation program at least three times, according to a study by the Substance Abuse and Mental Health Services Administration.(1) An estimated 14 million Americans, or 1 in 13 adults in the United States, abuse or are dependent on alcohol, according to the National Institute of Alcohol Abuse and Alcoholism. The health and social consequences of these diseases are staggering. Alcohol is the third most prominent contributor to mortality in the United States, following tobacco and diet/activity patterns. In addition to the 100,000 U.S. citizens who die each year from alcohol- related causes, the disease carries an annual price tag of $185 billion in direct and indirect social costs.(2) Peter