By Randall Osborne
The FDA's approval of Integrilin (eptifibatide), an anti-clotting agent for acute coronary syndrome, ended the roller coaster ride happily for COR Therapeutics Inc., which expects to begin marketing the drug "within the next three or four weeks," said Vaughn Kailian, president and CEO.
In January, an FDA advisory panel recommended clearance of Integrilin, COR's lead product, for angioplasty patients only, causing COR's stock to drop 53 percent. In April, however, the agency issued an approvable letter providing a broader indication — which made the stock soar 79 percent. (See BioWorld Today, Jan. 30, 1998, p. 1, and April 3, 1998, p. 1.)
The final outcome was approval of Integrilin for acute coronary syndrome (unstable angina and non-Q-wave myocardial infarction), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI), which comprises balloon angioplasty, atherectomy and stent replacement.
Whitehouse, N.J.-based Merck & Co. Inc.'s anti-platelet drug, Aggrastat (tirobifan HCI) was approved by the FDA earlier this week. Last November, the FDA gave the nod to an expanded label for ReoPro, the platelet inhibitor comarketed by its inventor, Centocor Inc., of Malvern, Pa., and Indianapolis-based Eli Lilly & Co. (See BioWorld Today, May 18, 1998, p. 1.)
"We don't think it's a crowded market," Kailian told BioWorld Today. "Only ReoPro is approved for all angioplasty patients, and Aggrastat got approved for acute coronary syndrome. We're approved for the combination of the two of them, but the one of greatest interest to us is acute coronary syndrome."
Integrilin is a synthetic peptide derived from the venom of the Southeastern pygmy rattlesnake. Like its competitors, the drug specifically blocks the GPIIb-IIIa receptor, which binds fibrinogen and mediates platelet aggregation.
Aggrastat will sell for $350 a day (regulated to body weight and a patient's medical needs) and treatment usually lasts two to three days, for a total of $1,050. ReoPro sells for about $1,350 per treatment.
Integrilin Price Not Set
"The ReoPro price is for 12 hours and the Aggrastat price is for three days, so they're not really apples-to-apples comparisons," Kailian said. "We haven't set the price yet [for Integrilin]."
Centocor's sales of ReoPro to Lilly in the quarter ending March 31 totaled $45.6 million, compared to $35.2 million for the same period in the year before. Lilly's sales to end-users were $70 million for the first quarter of this year, compared with $51.7 million for the first quarter of 1997.
COR's marketing partner, Schering-Plough Corp., of Madison, N.J., submitted a centralized marketing authorization application for Integrilin to the European Union's Medicines Evaluation Agency, and received notification in February that the application had been accepted for review.
As of March 31, COR had $77.9 million in cash, with a net loss for the quarter of $5.2 million. The company's stock (NASDAQ:CORR) closed Tuesday at $17.437, up $0.562. *