To: LWolf who wrote (691 ) 4/13/1998 8:27:00 PM From: Nick Respond to of 1580
Strong sales seen for Merck angina drug, Aggrastat NEW YORK, April 13 (Reuters) - Merck & Co.'s (MRK - news) candidate drug for unstable angina, Aggrastat, is unlikely to become a blockbuster but could eventually have strong annual sales of as much as $500 million if approved by the U.S. Food and Drug Administration, analysts said. A FDA advisory panel on Friday recommended Aggrasat for use in combination with the blood thinner heparin and aspirin to prevent heart attacks in patients with unstable angina and non-Q-wave myocardial infarction, also known as acute coronary syndrome. But the panel declined to vote on whether to recommend use of the drug for patients undergoing angioplasties to prevent heart attack, repeat procedures and abrupt artery closure. Angioplasties are procedures in which a balloon is inserted into clogged arteries to dilate the blood vessels and thereby improve blood circulation. The FDA's Cardiovascular and Renal Drugs Advisory Committee said it wanted to defer to the FDA on the angioplasty indication. Everen Securities analyst Jeffrey Kraws said he believed the FDA, which usually follows the recommendations of its advisory panels, will likely approve Aggrastat for both indications. ''And, I think it will be a $450 million to $500 million product by the year 2001,'' Kraws said, with its primary market the estimated 900,000 to one million Americans who seek treatment each year for unstable angina -- sharp chest pains that often precede heart attacks. He said the drug, with Merck's marketing muscle, should also reach many of the people undergoing an estimated 450,000 angioplasty procedures in the United States each year. Kraws noted that a similar FDA advisory panel on April 2 recommended approval of a COR Therapeutics Inc (CORR - news) drug, Integrilin, for both indications. It and Aggrastat are members of the same class of drugs, so-called glycoprotein IIb/IIIa antagonists. Kraws said it remains to be seen whether Integrilin, to be marketed by Schering-Plough Corp. (SGP - news), will reach the market before Aggrastat. The two drugs, if cleared by the FDA, will compete with ReoPro, the first approved glycoprotein IIb/IIIa antagonist, which garnered 1997 worldwide sales of $255 million. ReoPro was introduced in 1995 by Centocor Inc. (CNTO - news) and its marketing partner Eli Lilly and Co. (LLY - news). It is approved for angioplasty patients at high risk for complications and for unstable angina patients not responding to conventional medical therapy who plan within 24 hours to undergo percutaneous coronary interventions -- including angioplasty, atherectomy and stent placement. ABN-AMBRO analyst James Keeney on Monday reaffirmed his buy rating on Merck, saying sympathetic comments from FDA officials at Friday's panel meeting indicated Aggrastat was likely to be ''ultimately approved for all angioplasty procedures'' as well as for unstable angina. Keeney said he expected the agency to decide on Aggrastat by late April. If approved, he estimated the drug would garner sales of $85 million in 1998, rising to $500 million by 2001.