Lilly, Daiichi Sankyo Increase U.s. Backing For Plavix Adversary
Lillys medicine, prasugrel, was cleared yesterday by the Food and Drug Administration and will be sold under the name Effient, the agency said in an e-mail. The drug will carry the FDAs strictest warning, known as a black box, to doctors about an increased risk of potentially fatal bleeding.
Effient was approved in 5- and 10-milligram tablets to prevent heart attacks and strokes in patients with acute coronary syndrome who are undergoing angioplasty, an operation to repair or unblock a blood vessel. Tony Butler, an analyst at Barclays Capital in New York, said the strict warning may affect his estimate of $1.5 billion in global sales.
“At a black box level, it is different than the existing drugs and arguably it might have a slower uptake,” Butler said yesterday in a telephone interview. “In the mind of physicians, they have to make a hard decision about the benefit you get to the patients.”
Effient may reach yearly sales of $1.9 billion by 2015, said Seamus Fernandez, an analyst at Leerink Swann & Co. in Boston, in an April 7 note to clients. Plavix was an $8.2 billion seller last year for New York-based Bristol-Myers and Sanofi, based in Paris.
Broad Use
Plavix, second only to Pfizer Inc.s cholesterol pill Lipitor in sales, is approved for a broad population of patients, not just those undergoing procedures to unclog heart arteries.
Effient, which began selling in April in Europe under the alternative spelling “Efient,” may capture 20 percent of the Plavix market, said Tim Anderson, an analyst for New York-based Sanford C. Bernstein & Co., in a note to investors on Feb. 23. It may become the most-prescribed drug for patients with acute coronary syndrome undergoing angioplasty procedures, he said.
Lilly rose 32 cents, or 1 percent, to $33.32 at the close yesterday of New York Stock Exchange composite trading. The company has lost 31 percent in the past 12 months.
The drug is vital to plans by Indianapolis-based Lilly to replace lost revenue when its top seller, the antipsychotic Zyprexa, loses patent protection in 2011. Zyprexa had $4.7 billion in sales last year.
Panel Dustup
The approval process for Effient became the subject of a U.S. congressional inquiry after a critic of the drug was removed from a panel of FDA advisers. The agency said it was a “mistake” to drop Sanjay Kaul, a cardiologist, from the panel on Feb. 3 at Lillys urging four days earlier. Lilly had complained about research articles written by Kaul questioning the drugs safety and effectiveness. The FDA said it was concerned that Kaul might be biased.
Effient was designed to keep blood platelets from sticking together and forming clots that can lead to heart attacks, stroke or death. The tablets were tested in patients with heart attacks or severe chest pain who were undergoing a procedure to unclog the arteries, often followed with a mesh stent to prop them open.
Standard Care
About 850,000 of these procedures are performed each year in the U.S., according to Lilly. Plavix, known chemically as clopidogrel, is almost always prescribed, although studies have suggested it doesnt work in some patients with certain genetic variations or who are taking heartburn drugs.
The decision on Effient was initially delayed by the FDA in June 2008 when the agency said it needed more time to review information previously submitted by the companies.
“This had dragged on for some time — I think Lilly needed to get this behind them,” said Barclays Butler. “Here we are in July of the following year, and finally we have a decision.”
Plavix, which loses patent protection in 2011, is Bristol- Myerss best seller. Effients clinical trials were designed to show the drug is superior to Plavix and to persuade doctors to prescribe it over cheaper generic copies of Plavix.
A study presented in November 2007 at an American Heart Association scientific meeting found that the number of deaths from heart disease prevented by Effient was offset by a similar number of patients who experienced fatal bleeding.