Plavix gets FDA fast track status
Bounding Plavix sales could gain more momentum if FDA approves added use.
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.
To find out what's happening with Bristol-Myers in 2006, click here.