UPDATE 2-US panel rejects wider use of Forest drug

* Panel urges against wider approval for Bystolic

* FDA usually follows panel recommendations

* Forest says will talk with FDA ahead of deadline (Adds company, panelist comments, shares)

By Lisa Richwine

SILVER SPRING, Md., Jan 11 (Reuters) - A U.S. advisory panel on Monday unanimously rejected Forest Laboratories Inc's (FRX.N) bid to promote a hypertension pill for treatment of heart failure.

In an 8-0 vote, the committee said it would not recommend Food and Drug Administration approval of the drug, Bystolic, for reducing deaths and heart-related hospitalizations in heart failure patients.

Panelists said effectiveness data from the clinical trial Forest submitted to back the proposed wider use were not strong enough to win their endorsement, even when they considered other studies showing similar drugs helped heart failure patients.

"I would like to see some additional corroborating evidence," said Dr. Scott Emerson, a panelist and statistician at the University of Washington.

The FDA usually follows panel recommendations when deciding whether to approve drug applications. A decision is due by March 1.

An FDA reviewer already had recommended against approval. In a preliminary analysis released ahead of the panel meeting, agency reviewer Shona Pendse said several changes to Forest's heart failure study raised questions about the findings.

Forest is trying to widen the use of existing drugs and bring new products to the market ahead of the expected patent expiration in early 2012 of its biggest product, antidepressant Lexapro.

The company launched Bystolic in 2008 for treating high blood pressure, a much larger market than heart failure. The drug's second-quarter 2010 sales were $40.7 million.

Doctors are free to prescribe Bystolic now for any use they deem appropriate, but Forest needs FDA clearance to promote the drug specifically for heart failure.

Chronic heart failure is a condition in which the heart cannot pump enough blood throughout the body, which can lead to tiredness, shortness of breath and other symptoms.

About 5 million people in the United States have heart failure, according to the National Institutes of Health. The condition contributes to about 300,000 deaths each year.

Bystolic, known generically as nebivolol, is part of the family of heart drugs known as beta blockers that reduce heart rate and lower blood pressure.

Forest's study tested Bystolic in more than 2,000 heart failure patients age 70 and older to see if the drug reduced deaths or heart-related hospitalizations compared with a placebo. Forest said Bystolic cut the risk from 35 percent with a placebo to 31 percent with the drug.

The company also said the trial, conducted in Europe, tested people who were older and more like typical heart failure patients in the United States than in previous studies of other beta blockers.

Larry Olanoff, Forest's president and chief operating officer, said the company was "disappointed" with the panel decision. He said the company would talk with the FDA ahead of the March deadline about whether "there's some possibility of some form of labeling" that could be added to the drug to inform physicians and patients about the heart failure study.

Two beta blockers are currently approved for heart failure -- GlaxoSmithKline Plc's (GSK.L) Coreg and AstraZeneca Plc's (AZN.L) Toprol. Cheaper generic copies are sold for both drugs. Other heart drugs such as ACE inhibitors and diuretics also are commonly used to treat the condition.

Forest shares gained nearly 1.2 percent to close at $31.40 on the New York Stock Exchange. (Editing by Steve Orlofsky)