An Old Ulcer Drug Might Ease Some Plavix Risks

November 15, 2007, 6:15 pm
An Old Ulcer Drug Might Ease Some Plavix Risks
Posted by Ron Winslow

A Silicon Valley startup is betting that an iconic ulcer drug that’s gone generic can help cure part of what ails Plavix, the blockbuster anti-clotting medication.

Closely held Cogentus Pharmaceuticals is working on a pill, code named CGT-2168, that combines clopidogrel, the active ingredient in Plavix, with omeprazole, a/k/a Prilosec, the mother of all ulcer drugs before it went off patent a few years back.

The idea is that adding the generic version of AstraZeneca’s old purple pill will protect the gastro-intestinal tract, reducing bleeding associated with Plavix. If it works, the approach could make it easier for patients to stick with the medicine. “We believe doctors grossly under-appreciate the frequency and consequences of bleeding” associated with Plavix, Mark Goldsmith, president and CEO of Cogentus, told the Health Blog.

Plavix, a $6 billion-seller co-marketed by Bristol-Myers Squibb and Sanofi Aventis, is commonly prescribed with aspirin (itself associated with GI bleeding) for high-risk heart patients. That combo is especially common for patients who’ve had artery blockages treated with drug-coated stents. For them, going off Plavix heightens the risk for rare but potentially lethal blood clots forming in the stents. But bleeding is an important reason why some patients stop taking the drug.

That’s where Cogentus, backed by private funding of about $100 million, comes in. The company unveiled plans today to launch two phase III clinical trials involving more than 4,000 patients to test a combination of clopidogrel and omeprazole. Of course, not all bleeding associated with Plavix occurs in the GI tract, but if CGT-2168 makes a dent in the problem, intriguing marketing opportunities arise, Goldsmith suggested.

Cogentus could pursue a partnership with Bristol-Myers/Sanofi positioning the product as a next-generation Plavix to replace the current version, which loses patent protection in 2011. The combination might also give Plavix a leg up against Eli Lilly’s Prasugrel, a would-be rival that outperformed Plavix in a recent big clinical trial when it came to reducing heart attacks, but at a price of higher bleeding risk. Alternatively, Cogentus could hook up with another partner to launch into the lucrative anti-platelet category when the Plavix patent expires.

Then again, combo pills have a mixed record in the marketplace, posing a challenge for Cogentus. Will good results from its clinical trials persuade doctors and patients to choose a new brand-name combination treatment if each of its component parts is available at generic prices?