Bristol-Myers Squibb Seeks FDA Approval of Pravachol(reg) as an OTC Cholesterol-Lowering Therapy

Main Category: Cholesterol
Article Date: 12 Dec 2004 - 0:00 PST


Bristol-Myers Squibb Company (NYSE:BMY) announced that it intends to pursue US Food and Drug Administration (FDA) approval for an over-the-counter (OTC) version of Pravachol(reg) (pravastatin sodium) 20 mg as a cholesterol-lowering treatment option in the United States. Pravachol is approved in the United States only as a prescription drug.

The company also said that it has entered into an agreement with Bayer HealthCare LLC for Bayer's Consumer Care Division to handle OTC sales and marketing for pravastatin 20 mg in the United States, should the FDA approve OTC use of the drug. Bayer was selected given its experience in the cardiovascular category and the leadership position it has achieved in the marketing of the Bayer(reg) Aspirin brand.

About Pravachol

Pravachol (pravastatin sodium), a prescription drug, is indicated along with diet to reduce the risk of both first heart attack in patients with elevated cholesterol and recurrent heart attack or a stroke in patients with heart disease, when diet and exercise are not enough. Pravachol is not for everyone, including women who are pregnant or nursing or may become pregnant, or people with liver problems. And because serious side effects can result, patients should tell their doctor about any unexplained muscle pain or weakness they experience while on Pravachol, and about any other medications they are taking. Doctors may do blood tests to check for liver problems. It is recommended that liver function tests be performed prior to initiating therapy, prior to increasing the dose, and when otherwise clinically indicated. If a patient develops increased transaminase levels, or signs and symptoms of liver disease, more frequent monitoring may be required, and withdrawal of pravastatin therapy is recommended if an increase in AST or ALT of three times the upper limit of normal or greater persists. Some mild side effects, such as slight rash or stomach upset, occurred in two to four percent of patients.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.

For more information, contact: Media - Robert Hutchison, 609-252-3901, robert.hutchison@bms.com; Investors - John Elicker, 212-546-3775, john.elicker@bms.com

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. OTC pravastatin has not been submitted for regulatory approval. There can be no guarantee that OTC pravastatin will receive regulatory approval, or if approved, will be commercially successful. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2003 and in our Quarterly Reports on Form 10-Q. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

http://www.bms.com/news/press/data/fg_press_release_5203.html

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