Daiichi confident of Effient approval

Joe Pieroni, North American President and CEO of Daiichi Sankyo, Inc., speaks at the Reuters Health Summit in New York, November 20, 2008.

NEW YORK (Reuters) - Daiichi-Sankyo's (4568.T) top U.S. executive expressed confidence that the blood clot preventer it is developing with Eli Lilly & Co (LLY.N) will soon win U.S. approval, and said the sales force for the medicine was champing at the bit to get started.

"We're feeling confident in the approval of Effient," said Joe Pieroni, Daiichi-Sankyo's head of U.S. commercial operations, using the proposed brand name for the closely watched anti-clotting drug known chemically as prasugrel.

"We're fairly confident we're getting to the end of the approval process with Effient," Pieroni told the Reuters Health Summit in New York on Thursday.

U.S. health regulators have twice delayed a decision on prasugrel, a drug that would compete directly with Plavix, the world's second-largest selling medicine, which is sold by Bristol-Myers Squibb Co (BMY.N) and Sanofi-Aventis (SASY.PA).

The Food and Drug Administration in September let an action date for an approval decision pass, saying it had not completed its review but gave no indication of when it might give the drug a thumbs-up or down. That came of the heels of a prior three-month review extension.

Pieroni said he did not know if the FDA planned to hold an advisory panel meeting to discuss the drug prior to making a decision on allowing its sale in the United States. But he does not expect the agency to require any more clinical testing.

"To say we need another study would be a big curveball," Pieroni said. "That would be unexpected."

Pieroni said the Effient sales force is trained and ready and that Daiichi and Lilly will have enough primary care sales representatives to match Sanofi's Plavix force.

"The sales force is definitely ready to go, more than ready to go. Did you ever see the horses when they're in the gate?," he joked.

The companies signaled their confidence in the drug last week in New Orleans, where buses passing the site of a major heart meeting were plastered with ads saying "Coming soon: Effient."

Asked if he expected Effient would be a multibillion-dollar seller, Pieroni said, "We're very hopeful about that."

Daiichi is also excited about another experimental blood thinner it is developing that it hopes could one day replace widely used warfarin, which has been on the market for more than a half century but is notoriously difficult for doctors and patients to manage because of severe bleeding risks.

Daiichi's DU-176B belongs to a new class of medicines called factor Xa (10 A) inhibitors which block a protein involved in the clotting process.

Factor Xa is a hot area of drug research. Bayer AG BAYG.DE and Johnson & Johnson (JNJ.N) are developing a factor Xa drug called rivaroxaban, while Bristol-Myers Squibb Co (BMY.N) and Pfizer Inc (PFE.N) are busy testing their apixaban.

Collaborations that share risk and profit are becoming much more common among large drug makers, but Daiichi said it prefers to go it alone with DU-176B.

"We'd like to take this ourselves," Pieroni said.

The companies are all hoping to show their drugs can prevent strokes among patients with an irregular heartbeat condition called atrial fibrillation. The factor Xa drugs are also being studied to see if they are better than standard treatments in preventing dangerous blood clots after hip and knee-replacment surgery -- a much smaller market than atrial fibrillation.

The Daiichi product has gotten comparatively little publicity as the company preferred to first obtain enough clinical trial data to understand its potential before putting it in the spotlight, Pieroni said.

"We're confident now that we have a competitive product," he said.

(Editing by Lisa Von Ahn and Matthew Lewis)