July 22, 2009 / 7:28 PM / 10 years ago

UPDATE 1-Paltry EU sales of Lilly clot drug raise concern

(Adds details on second-quarter earnings, shares)

By Ransdell Pierson

NEW YORK, July 22 (Reuters) - Eli Lilly and Co’s (LLY.N) new prasugrel blood clot preventer posted second-quarter European sales of just $300,000, raising some initial concern about its long-term sales prospects overseas and in the crucial U.S. market.

“You would think that if there was such an urgent need for this product there would be more sales in international markets” by now, Leerink Swann analyst Seamus Fernandez said on Wednesday, after Lilly released second-quarter results.

Fernandez said international sales of the product were limited in large part because the countries have not yet established reimbursement guidelines for the drug, being sold under the brand name Efient in Europe.

“But you’d think if there was such an urgent need for this product, there would be more sales in international markets, regardless of the reimbursement situation,” Fernandez said.

He noted that some European patients pay for drugs out of pocket, and doctors insist on using them, if they are deemed sufficiently compelling.

The long-awaited pill was approved by European regulators on February 23 to prevent blood clots that can cause heart attacks and stroke among patients undergoing procedures to clear clogged heart arteries.

Lilly has introduced its medicine in the United Kingdom, Germany, Denmark and Greece and will roll it out to more European nations in coming months.

The company plans to launch the pill in the United States early next month under the name Effient, following its approval on July 10 by the U.S. Food and Drug Administration.

Lilly is counting on the pill, which it developed in partnership with Daiichi Sankyo Co (4568.T), to become a big seller and fuel the Indianapolis drugmaker’s future earnings growth.

The drug proved more effective in clinical trials than Sanofi-Aventis’ (SASY.PA) blockbuster anti-clot pill Plavix, but caused a greater incidence of potentially serious bleeding.

Lilly spokesman Mark Taylor said Lilly is still working out reimbursement procedures with the European countries and that the overseas launch has therefore been “very limited.”

“I would not take the last quarter’s performance as any indication of the market potential for Efient in Europe; it’s way too early to draw that conclusion,” Taylor said

The drug’s package insert label in the United States carries a prominent “black-box” warning that the product can cause significant, sometimes fatal bleeding and should not be used by those with certain bleeding problems, a history of stroke, or an urgent need for surgery.

Lilly reported better than expected quarterly earnings on Wednesday, helped by price increases that boosted sales of its medicines. But its shares were down 1.8 percent in late afternoon trading, after the drugmaker cautioned that currency factors which bolstered results in the first half of 2009 would not be seen for the rest of the year. (Reporting by Ransdell Pierson; editing by Carol Bishopric)

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