[Fred Hassan keeps talking about this unnamed drug, so he is presumably looking for really big bucks to partner it with a bigger pharma than SGP. Unlike LLY’s program for prasugrel (#msg-14220330), which aims to supplant Plavix (the world’s second-largest-selling drug), SGP’s plans are to augment Plavix. The phase-3 trials—one for post-hoc treatment and one for prevention—have tough “outcomes” endpoints and won’t be a cakewalk. But the upside is very large, thanks in part to the growing recognition that patients who receive a drug-eluting stent may have to remain on antiplatelet therapy forever.]
NEW YORK, Jan 8 (Reuters) - Schering-Plough Corp. said on Monday its experimental anti-clotting drug has potential to be a "transformational" product in further reducing risk of heart attack and stroke, without adding to bleeding risks seen with standard treatments for heart patients.
The once-daily pill, now completing mid-stage trials, prevents blood cells called platelets from clumping together, but through a different means than aspirin and Bristol-Myers Squibb Co.'s <BMY> widely used Plavix.
Enrico Veltri, head of cardiovascular clinical research for Schering-Plough <SGP>, said the drug works instead by blocking a clot-causing protein called thrombin from docking on platelets.
"We're hoping that by using our anti-platelet drug on top of aspirin and Plavix, it can reduce cardiovascular events by at least another 15 percent," without causing any incremental bleeding risk, Veltri told Reuters.
Aspirin and Plavix are routinely given to patients who arrive in emergency rooms with chest pains or heart attacks, and help prevent new blood clots in clogged arteries that can cause further heart damage or choke off blood supply to the brain.
But both drugs, now considered the standard of care, cause bleeding that can limit their use and pose risks to patients who need to undergo surgery, including bypass surgery.
Schering-Plough Chief Executive Fred Hassan last week said his drug has potential to achieve blockbuster sales if it succeeds in two late-stage trials that could begin later this year. Other drugmakers have expressed strong interest in helping develop and sell the product, he said.
"This one is so interesting that many large companies would see this as a better opportunity to invest in for late-stage trials than anything that they may have in their own pipelines," Hassan said at a Morgan Stanley conference. "It is one of those mega-opportunities out there."
Veltri on Monday said many other drugmakers have tried for the past 12 years to develop a drug that blocks the thrombin receptor, but none have made it to mid-stage trials because of toxicity or other problems.
"We believe ours is the farthest one along in clinical trials," he said, and that it could have major marketing advantages if it is the first such drug to hit the market.
Schering-Plough expects data within months on its mid-stage trial of the drug, involving more than 1,000 patients who had planned to undergo procedures to clear their clogged arteries. Such procedures typically include insertion of stents to keep the blood vessels propped open.
The primary goal of the Phase II trial is to establish that the drug, when used alongside aspirin and Plavix, does not cause additional bleeding.
For both of the subsequent late-stage trials, the company aims to prove that patients receiving its medicine in combination with aspirin and Plavix have fewer heart attacks, strokes and cases of cardiovascular death than those taking only aspirin and Plavix -- without additional bleeding.
One of the Phase III trials will enroll patients soon after they have visited hospitals with chest pains or heart attacks to assess the drug's effectiveness as a treatment. The other trial, involving patients that have previously had heart attacks or strokes, will assess whether the drug can prevent new attacks. <<
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