WASHINGTON -- Merck & Co. won U.S. approval yesterday to sell its Aggrastat drug, a new competitor in a potential $1 billion-plus heart-drug market now controlled by Centocor Inc.
The U.S. Food and Drug Administration approval is a setback for South San Francisco, Calif.-based Cor Therapeutics Inc., which earlier appeared to be ahead in the race to become the second company with one of the so-called anti-platelet drugs on the market.
The drugs work by preventing tiny blood cells known as platelets from sticking together and forming potentially deadly blood clots. Merck said Aggrastat was cleared for use in patients suffering from conditions known as unstable angina and non Q-wave myocardial infarction, marked by severe chest pain caused by a blockage in the artery.
The news came after the close of trading on U.S. markets. Shares of Whitehouse Station, N.J.-based Merck rose 68.75 cents to close at $118.0625 in trading yesterday. Cor shares fell 43.75 cents to close at $18.75 and Centocor shares rose 56.25 cents to close at $43.9375.
Each company will now try to play up its strength to garner a larger share of the market that some analysts say could exceed $1 billion a year.
Centocor has the benefit of a three-year head start and a strong presence in the market for patients expected to undergo the artery-opening procedure known as angioplasty.
Merck, meanwhile, has the benefit of its powerhouse marketing team and a successful track record with cardiologists.
Aggrastat enters a stable of successful Merck heart drugs that include Zocor and Mevacor for high cholesterol levels, Cozaar for high blood pressure, and Vasotec and Prinivil, used to treat high blood pressure and other heart conditions.
Currently, Centocor's ReoPro is only approved for patients expected to undergo artery-opening procedures such as angioplasty. While the company is continuing to study the drug's other benefits, ReoPro sales are expected to top $350 million in 1998 based on that use alone.
Cor, meanwhile, received preliminary approval in April for its Integrilin drug to treat patients undergoing artery-opening procedures as well as the approximately 1 million U.S. patients who each year suffer from unstable angina or non Q-wave myocardial infarction.
The label for Aggrastat allows its use in that same group of patients.
Still, both Merck's Aggrastat and Cor's Integrilin require longer infusion times than Centocor's ReoPro, which could hurt their sales, analysts said. Eli Lilly & Co. sells Centocor's ReoPro and Schering-Plough Corp. will sell Cor's Integrilin.
Meanwhile, other companies are working on oral versions of the drugs to make them easier to use. Monsanto Co.'s Searle unit showed strong initial results for its oral drug, Xemilofiban, at a medical meeting in November.
Pub Date: 5/15/98