Forest Labs FDA Panel Review and Phase II Clinical Trial Results

Chemical Structure of Ceftaroline This just in to marketwatch today.

Forest-Gedeon Richter drug misses overall goal

TEL AVIV (MarketWatch) -- Forest Laboratories Inc. FRX 29.56, +0.37, +1.27%) and Gedeon Richter PLC said Monday that in a Phase II study of cariprazine, a potential treatment for bipolar depression, the overall result for patients taking the drug was not statistically different from that of the patients taking placebo. In higher doses, however, the antipsychotic drug did show "evidence of a clinically relevant treatment effect," the drugmakers, based respectively in New York and Budapest, said. The primary endpoint was the scores on the Montgomery Asberg Depression Rating Scale, they said. The companies are mulling whether to do another Phase II study of the drug to examine a wider range of doses. Meantime, the drug is in Phase III trials for, separately, schizophrenia and bipolar mania

News concerning Tomorrow's FDA decision. This is an antibiotic up for approval up for review tomorrow Sept. 7th, 2010.

FDA Panel Alert: Forest Labs

Forest Labs Antibiotic Seems Effective FDA Notes Revealed

Image via Wikipedia FDA staff back safety, efficacy of ceftaroline

* Advisory panel to review drug on Tuesday
* Forest shares up 5.4 pct in afternoon
* Nearly $361 million in ceftaroline sales seen in 2014 (Revises first sentence, adds analyst comment, updates shares)
By Lisa Richwine

WASHINGTON, Sept 2 (Reuters) - A Forest Laboratories Inc (FRX.N) antibiotic appears effective with risks similar to current options, U.S. drug reviewers said in an analysis that raised hopes for the medicine's approval.

Shares of Forest, which needs new medicines to offset looming patent expirations on its major drugs, were up $1.49 or 5.4 percent at $29.14 on the New York Stock Exchange after the Food and Drug Administration released its preliminary review on Thursday.

Analysts expect nearly $361 million in sales in 2014 for the potential new antibiotic called ceftaroline, according to Thomson Reuters forecasts.