Will Plavix Competitor Cangrelor Be a Prince Rather than a Frog for The Medicines Co.?
The Medicines Co., which six months ago stopped two likely-to-fail Phase III trials of antiplatelet drug cangrelor, is out to prove its frog of a drug may be a prince after all.
Medicines has a thing for drugs with a few warts on them. The company markets the anticoagulant Angiomax (bivalirudin), which it licensed from Biogen after a Phase III failure. It also markets hypertension drug Cleviprex (clevidipine butyrate), a cast-off from AstraZeneca.
And Medicines' only other late-stage drug, the antibiotic oritavancin, was passed from Eli Lilly to Intermune to Targanta Therapeutics and boasts an FDA complete response letter. When Medicines announced its acquisition of Targanta and the beleaguered oritavancin, chairman and CEO Clive Meanwell said he was "not blind to the warts on this drug."
Cangrelor is no different: it, too, came from AstraZeneca. But many viewed it as less risky than oritavancin, and analysts had projected its $300 million or so in annual revenues could help offset the patent expiration on Angiomax (which is coming early thanks to a lawyer who was a day late and $800 million short on a patent deadline).
That's why Medicines' stock plunged 40 percent earlier this year when it stopped two huge Phase III trials after an interim analysis showed cangrelor was unlikely to outperform Plavix (clopidogrel) in patients underoing percutaneous coronary intervention (a.k.a angioplasty).
But the full analyses from those trials â€" presented Sunday at the American Heart Association annual meeting and published in the New England Journal of Medicine â€" indicate cangrelor may have life in it yet.
The drug did not beat Plavix on the primary endpoint (preventing death, heart attack or ischemia driven revascularization [IDR] at 48 hours), but cangrelor did win on a few other composite measures (prevention of death, Q-wave heart attack or IDR; or prevention of death, Q-wave heart attack or stent thrombosis). It also beat Plavix in lab tests of platelet inhibition.
Medicines plans to discuss its data with regulators, but the company was cautious in its press release:
"Although these endpoints were a pre-specified component of the primary endpoint, their combinations were devised post-hoc and so the data cannot be deemed conclusive," said Deepak L. Bhatt, M.D., M.P.H "But these findings are biologically plausible and suggest superior antiplatelet effects and clinical potential."Still, this frog looks more kissable than it did six months ago.
Frog Prince photo by Flickr user jennifer.barnard, CC