Uncertainty over when, or if, the U.S. Food and Drug Administration will approve prasugrel, a blood-thinner Eli Lilly and Co. hopes will be its next blockbuster, has taken a bite out of the company's already slumping stock.
Lilly shares closed Friday at $32.20, down $2.18, or 6.3 percent. It ticked up this morning, to $32.68, but is down 39 percent for the year.
Friday's tumble followed a pharmaceutical industry publication's report that the FDA is convening a February meeting to discuss prasugrel.
The move likely would delay a decision on the new drug until March, according to The Pink Sheet, a weekly publication that covers regulatory action at the FDA and other federal agencies. That would be a blow to Indianapolis-based Lilly, which faces a wave of patent expirations in the next few years and is counting on prasugrel to ease the pain.
It submitted the drug for approval late last year, and the FDA agreed to a six-month review period. Before the June deadline, regulators delayed their decision another three months. Lilly issued a statement Sept. 26 saying the review still was not complete.
"The further delay of prasugrel ... will represent an overhang on Lilly shares," wrote J.P. Morgan pharmaceutical analyst Christopher Schott in a note to investors on Friday.
The Pink Sheet reported that the FDA has contacted members of its Cardiovascular and Renal Drugs Advisory Committee about a February meeting to discuss prasugrel. The publication said a "serious internal disagreement ... has developed over whether to approve the drug."
Lilly and drug development partner Daiichi Sankyo Co. Ltd. issued a statement late last week saying they have not been notified of any regulatory action or of any decision to have an advisory committee to review prasugrel.
Analysts initially tagged prasugrel with blockbuster potential when it proved better at reducing heart-related deaths than the current leading treatment, Plavix. That drug, made by New York-based Bristol-Myers Squibb Co. and France-based Sanofi Aventis, racked up $8.5 billion last year in sales.
But prasugrel also led to higher rates of bleeding in patients who were older, lighter weight, and who had previously suffered a stroke.