Biotech Values

[genisi]

FRX/ceftaroline (apropos to the FDA guidance and ever-changing goalposts)

Phase III program for ceftaroline was initiated in 2007 under the old FDA standards and the primary efficacy endpoint was noninferiority on symptoms resolution at the test-of-cure visit 7-14 days after EOT. Interestingly, the antibiotic was noninferior to the comparator even under the FDA's new efficacy criteria - cessation of spread of the lesion along with absence of fever at day 3.
Briefing docs:

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/UCM224656.pdf

US FDA staff: Forest antibiotic seems effective

http://www.reuters.com/article/idCNN3127328720100902?rpc=44

* 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

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.

An FDA advisory panel will review the drug at a public meeting on Tuesday. A positive vote would move the medicine closer to the U.S. market.

In a 70-page analysis released on Thursday, FDA staff said ceftaroline seemed effective for fighting serious skin infections and pneumonia. Potential side effects were similar to alternative treatments, they said.

"FDA appears to go into the panel with a positive bias toward approval" for both conditions, Robert W. Baird analyst Thomas Russo said in a research note. He predicted the stock would close $1 to $2 higher on Thursday.

Ceftaroline 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.

Ceftaroline is an intravenous antibiotic developed to fight serious and possibly life-threatening infections including methicillin-resistant Staphylococcus auereus (MRSA), a growing public health threat.

FDA staff analyzed Forest's data from two clinical trials in adults with bacterial pneumonia acquired outside a hospital setting. The agency reviewers said their analysis "supported the efficacy conclusions" from Forest that the drug worked as well as an older antibiotic, ceftriaxone.

The drug also appeared equivalent to a combination of the antibiotics vancomycin and aztreonam in two studies of adults with complicated skin infections, FDA staff said.

Ceftaroline is a new medicine in the cephalosporin class of antibiotics that have been used for decades.

The most common possible side effects include diarrhea, headache, nausea and insomnia.

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

"Ceftaroline addresses these distinct areas of unmet medical need," the company said.

The FDA will consider the advisory panel's input when it decides in the coming weeks whether to approve the drug. The agency usually follows panel recommendations.

Forest obtained rights to ceftaroline with its 2007 purchase of privately held biotech company Cerexa Inc. Swiss drugmaker AstraZeneca (AZN.L) is co-developing the drug in markets outside the United States, Canada and Japan. Takeda Pharmaceutical Co (4502.T) holds the rights in Japan.