Plavix gets FDA fast track status
Bounding Plavix sales could gain more momentum if FDA approves added use.
By Aaron Smith, CNNMoney.com staff writer


NEW YORK (CNNMoney.com) - Bristol-Myers Squibb and Sanofi-Aventis got some good news from the FDA that could add sales momentum to fast-growing Plavix, a top-earning drug for both companies.

The Food and Drug Administration granted fast-track review process for Plavix, an anti-stroke blood thinner that is being considered for an additional use: the treatment of a certain type of heart attack where blocked arteries cause muscle damage also known as, acute ST-segment elevation myocardial infarction (STEMI).

Fast track review is reserved for drugs treating cancer, heart disease and other life-threatening diseases, with a six-month review goal for the FDA, compared to a 14-month review target for other drugs. Bristol-Myers said the FDA target date for the supplemental Plavix review is May 17, 2006.

Plavix is the top-selling drug for Bristol-Myers (down $0.24 to $22.06, Research), a New Jersey-based drug maker, and its partner Sanofi-Aventis (down $0.33 to $45.75, Research), a Paris-based drug maker.

Despite getting locked into patent battles with generic manufacturers, Plavix sales are growing fast. Bristol-Myers reported $2.8 billion in Plavix sales for the first nine months of 2005, a 17 percent jump from the same period in 2004. Sanofi-Aventis reported $1.8 billion in Plavix sales for the first nine months of 2005, an increase of 21 percent.

Plavix sales take the lion's share of total sales for both Bristol-Myers and Sanofi-Aventis. Bristol reported total sales of $14.8 billion in the first nine months of 2005, while Sanofi, the biggest drug maker in Europe, reported $24.5 billion for the same period.

Le Anne Zhao, analyst for Caris & Co., said the additional indication for Plavix could mean another $500 million in annual revenues, to be split between Bristol-Myers and Sanofi-Avenits.

Other analysts believe that the additional indication could add momentum to Plavix's already-rapid growth.

"We expect [Plavix] to keep growth robust," said Robert Hazlett, analyst for Suntrust Robinson Humphrey.

John LeCroy, analyst for Natexis Bleichroeder, projected 15 percent growth for Plavix sales for Bristol-Myers in 2005.

"It's a massive drug right now," said LeCroy, referring to Plavix. "It already gets massive use, a lot of it off-label."

The analysts interviewed here do not own shares in Bristol-Myers and their firms do not conduct business with the company. The analysts do not cover Sanofi-Aventis.

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To find out what's happening with Bristol-Myers in 2006, click hereTop of page

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Most stock quote data provided by BATS. Market indices are shown in real time, except for the DJIA, which is delayed by two minutes. All times are ET. Disclaimer. Morningstar: © 2018 Morningstar, Inc. All Rights Reserved. Factset: FactSet Research Systems Inc. 2018. All rights reserved. Chicago Mercantile Association: Certain market data is the property of Chicago Mercantile Exchange Inc. and its licensors. All rights reserved. Dow Jones: The Dow Jones branded indices are proprietary to and are calculated, distributed and marketed by DJI Opco, a subsidiary of S&P Dow Jones Indices LLC and have been licensed for use to S&P Opco, LLC and CNN. Standard & Poor's and S&P are registered trademarks of Standard & Poor's Financial Services LLC and Dow Jones is a registered trademark of Dow Jones Trademark Holdings LLC. All content of the Dow Jones branded indices © S&P Dow Jones Indices LLC 2018 and/or its affiliates.