Lilly, Daiichis Prasugrel Backed With Restrictions
Lillys shares fell after the Food and Drug Administration posted the staff report today. The drug was found to help heart- attack patients. Still, some reviewers said the medicine should be used only for short periods and carry the strictest caution about the danger of excess bleeding. The report also suggested excluding patients older than 75 and warning about cancer risks.
Conditions and warnings may make it harder for the drug to take sales from Plavix, an $8.1 billion seller for Bristol-Myers Squibb Co. and Sanofi-Aventis SA. Prasugrel, to be sold as Effient, is vital to Indianapolis-based Lillys plans to replace revenue lost when its top-selling antipsychotic Zyprexa loses patent protection in 2011.
“It does set the product up for a difficult launch, since the label will contain a warning and patients will need to be enrolled in a patient management system, which could be an added hassle and scare for some doctors,” Jon LeCroy, an analyst at Natixis Bleichroeder in New York, said in a note to clients today. He recommends selling Lilly shares and doesnt own them.
Outside advisers to the FDA will meet Feb. 3 in the Washington suburb of Silver Spring, Maryland, to discuss the staffs findings and recommend whether Effient should be cleared for sale. The agency has also asked the committee of doctors and scientists to consider what limitations would be needed if the drug is approved.
Shares Fall
Lilly dropped $1.15, or 3 percent, to $36.82 at 4 p.m. in New York Stock Exchange composite trading. The drugmaker also announced today that its U.S. president, Deirdre Connelly, is departing for GlaxoSmithKline Plc. Before the review was released, Daiichi Sankyo fell 15 yen to close at 2,040 yen in trading in its hometown of Tokyo.
Effient is designed to prevent blood clots in patients with heart problems who are undergoing procedures to unclog their arteries. These procedures, called percutaneous coronary interventions, are usually followed by insertion of a stent to keep the arteries propped open.
A company-funded study of 13,000 patients found that Effient prevented more heart attacks than Plavix, though more people taking Effient died from bleeding. The drug was also linked to an increased risk of stroke in patients who had previously had one, and more cases of cancer, according to the FDA review.
Disagreement on Limits
The agencys Division of Cardiovascular and Renal Products recommended that Effient be marketed to prevent heart attacks. At the same time, it said too little proof existed to support the companies request to claim a benefit against strokes or deaths.
While some reviewers suggested limiting Effient use to one week to manage the risk of bleeding and prevent a possible association with cancer, there was no consensus in the agency report whether this was necessary.
Deadline Missed
Lilly and Daiichi Sankyo applied for FDA approval in December 2007. The agency early last year granted a priority review, with a decision due in June rather than the longer wait typical under the standard review. The FDA extended the review when new data became available, then missed a September deadline for action, and said Dec. 31 it would convene the advisory panel.
The FDA hasnt told Lilly when it will decide on the application, Chief Executive Officer John Lechleiter said to investors on Jan. 7. The agency usually follows the recommendations of its advisory panels, though it isnt required to do so.
A European advisory panel recommended approval of Effient on Dec. 18, and a final ruling by the European Commission typically follows within three months.
Barbara Ryan, an analyst at Deutsche Bank in Greenwich, Connecticut, expects FDA approval of Effient in the second half of this year and annual sales of $1.3 billion by 2013.
The “cautionary/restrictive language” recommended in the FDA staff review “is consistent with our views for this drug,” Ryan said today in a note to clients. She has a hold rating on shares and doesnt own any.
Even if the drug is approved, it may not be enough to make up for the loss of Zyprexa sales, according to Tim Anderson, an analyst at Sanford C. Bernstein & Co. in New York.