Angiomax: Tortured path to a lot of competition
It has been a long road for Angiomax bivalirudin, a direct thrombin inhibitor derived from the leech compound hirudin. Biogen Inc. stopped development of the compound, then called Hirulog, in 1994 after a Phase III trial in angioplasty failed to show the compound's superiority to heparin. In March 1997, BGEN sold the compound to The Medicines Co., which unsuccessfully tried to convince the FDA to approve it.
After submitting additional, undisclosed, clinical data to the agency, Medicines last week finally received an FDA approvable letter for Angiomax to treat patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). In its wake, the company filed for an IPO (see Ax ).But now the company faces an even tougher challenge: penetrating the anticoagulant market...