FDA experts say Merck HIV drug safe, effective

NEW YORK (CNNMoney.com) -- FDA advisers believe that an experimental HIV drug from Merck is safe and effective, based on documents released by the agency.

An FDA document posted on the agency's Web site said the advisers "support the applicant's findings," referring to Merck's safety and efficacy data.

Anti-viral experts for the Food and Drug Administration based their opinion of Merck's (up $0.51 to $50.17, Charts, Fortune 500) experimental HIV treatment, Isentress, on analyses of the company's own studies.

On Sept. 5, the advisers are scheduled to vote on whether Isentress merits approval. The results of this non-binding vote will be considered by regulators when they make their final decision in mid-October.

Joe Tooley of A.G. Edwards projects that Isentress, also known as raltegravir, will reach annual sales of $750 million by 2011.

There is no vaccine or cure for HIV, the human immunodeficiency virus that causes AIDS, which makes patients vulnerable to illnesses and diseases by wearing down their immune systems.

The introduction of new AIDS medicines is important because the constantly-mutating HIV develops resistance to existing therapies. Also, HIV patients often develop resistance to treatments over time, so they have to switch to new drugs.

Merck & Co. Inc., based in Whitehouse Station, N.J., is the third-largest U.S. drug company in terms of annual sales, behind Johnson & Johnson (up $0.19 to $61.79, Charts, Fortune 500) and Pfizer, Inc. (up $0.29 to $24.84, Charts, Fortune 500)

On Aug. 6, the FDA approved Selzentry, also known as maraviroc, an AIDS treatment from Pfizer.

Tooley does not own Merck shares, but A.G. Edwards has received compensation from the company in the last 12 months for non-investment banking services.