Tuesday, September 2, 1997
The consensus on Wall Street last week was that Phase III data
from Cor Therapeutics Inc.'s PURSUIT trial of its Integrilin GPIIb/IIIa inhibitor
in unstable angina give the company an approvable product. The bigger question
for CORR is whether it will be able to carve out a piece of the cardiology market
from Centocor Inc.'s ReoPro, an antibody that inhibits the same receptor on
platelets, as well as other GPIIb/IIIa inhibitors in development.
The additional competition includes Aggrastat tirofiban MK-383 from Merck & Co. (Whitehouse Station, N.J.).
As presented last week, PURSUIT showed a significant reduction in death or heart attack 30 days after treatment (see BioCentury Extra, Aug. 26). CORR (South San Francisco, Calif.) plans to submit data from PURSUIT to the FDA as an amendment to its existing NDA for Integrilin, asking for approval for both the original angioplasty claims as well as for unstable angina/non-Q-wave myocardial infarction. The angioplasty data, based on CORR's IMPACT II trial, had earlier been deemed insufficient for FDA approval, as results showed positive but not significant trends at lower doses of Integrilin than were used in the PURSUIT study.
Comparing the data
The chart below provides data from seven trials of the three products