US FDA staff--Forest antibiotic seems effective-UPDATE 2

Trade the News

Thursday September 02, 2010 02:10:14 AM GMT

* Complications similar to other drugs - FDA staff

* Advisory panel to review ceftaroline on Tuesday

* Forest shares gain over 3 percent

* Nearly $361 million in ceftaroline sales seen in 2014 (Adds comments from FDA, company; shares; forecasts)

By Lisa Richwine

WASHINGTON, Sept 2 (Reuters) - A Forest Laboratories Inc antibiotic appeared effective in clinical trials for treating skin infections and pneumonia, U.S. drug reviewers said on Thursday in an analysis released ahead of a key panel review.

The FDA reviewers will present their analysis to an advisory panel that meets Tuesday to consider whether to recommend approval for the drug, ceftaroline. A positive vote would move the medicine closer to the U.S. market.

Analysts are expecting nearly $361 million in ceftaroline sales in 2014, according to Thomson Reuters forecasts. Forest shares rose 3.4 percent to $28.60 on the New York Stock Exchange.

Potential side effects from the injectable medicine were similar to comparison treatments, Food and Drug Administration staffers also said in a preliminary review.

The antibiotic is one of six medicines in late-stage development that Forest says will more than replace the coming revenue losses from patent expirations on flagship antidepressant Lexapro and Alzheimer's treatment Namenda.

The company reported net revenue of nearly $4.2 billion for the fiscal year ended March 31.

For ceftaroline, FDA staff analyzed Forest's data from two clinical trials in patients with bacterial pneumonia acquired outside a hospital. The FDA analysis "supported the efficacy conclusions" from Forest, the agency reviewers said.

They also said the drug appeared equivalent to a comparison treatment in patients with complicated skin infections.

In a separate summary prepared for the advisory panel, Forest said new antibiotics are needed to fight resistant infections that do not respond to current treatments.

"Ceftaroline addresses these distinct areas of unmet medical need," the company said. (Editing by Gerald E. McCormick)

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