UPDATE 4-Lilly, Daiichi blood-thinning drug faces FDA delay
(Adds Lilly comment, further analyst comment; updates shares)
By Sachi Izumi and Ben Hirschler
TOKYO/LONDON, June 24 (Reuters) - U.S. regulators have extended the review period for Eli Lilly and Co (LLY.N) and Daiichi Sankyo's (4568.T) new blood-thinning drug prasugrel, delaying a decision on approval by three months.
Lilly shares fell as much as 3.4 percent in New York trading on Tuesday to their lowest in about six years. Daiichi shares slumped 2.3 percent in Tokyo.
Prasugrel -- a rival to Plavix from Sanofi-Aventis (SASY.PA) and Bristol-Myers Squibb Co (BMY.N) -- is a critical experimental medicine for Lilly and Daiichi.
The companies said the Food and Drug Administration's review period would now run until Sept. 26 to complete a review of supplemental information about the drug.
Devesh Singh, an analyst with Mehta Partners, predicted that prasugrel would win approval by the new deadline, noting the delay did not reflect concerns about the medicine.
"We don't see anything changing our view on prasugrel ... because this delay is not related to the drug," Singh said, adding that he believed Daiichi and Lilly shares would soon recover Tuesday's losses.
Lilly and Daiichi submitted their application to the FDA on Dec. 26 for prasugrel. The application was reviewed on a priority basis, which shortens the review time to six months from the typical 10 to 12 months.
Dr. Anthony Ware, a Lilly vice president who leads cardiovascular and acute care development, said the companies remained confident in the overall submission package.
The FDA had asked for additional analyses of the data, Ware said, although he declined to specify the information that the agency requested.
"There's been nothing that's stumped us," Ware said in an interview.
The prasugrel application is the largest in Lilly's history, Ware said. "They certainly have a lot to review in a short period of time," he said.
Meanwhile, Sanofi shares rose 1.4 percent in Paris, while Bristol-Myers shares were down less than 1 percent.
"This news will come as a welcome but likely temporary respite to Sanofi-Aventis and Bristol-Myers," said Nomura Code analyst Mike Ward.
BLOCKBUSTER HOPES
Tim Anderson, an analyst with Sanford Bernstein, said the delay was not wholly surprising given the amount of data that was submitted to FDA and controversy over how to define precisely which patients should use the product.
He also noted that senior FDA staff have recently commented that the agency is essentially under-funded and under-resourced to do all that it needs to do.
Anderson forecasts prasugrel sales of $952 million in 2015, by which time the drug will contribute about 25 cents, or 11 percent, to the U.S. group's earnings per share.
Other analysts have predicted prasugrel will become a multibillion-dollar product, though some believe its prospects have dimmed since mixed results from a large study were released late last year.
In that study, the drug proved better able to prevent heart problems than Plavix, but prasugrel caused a higher incidence of serious bleeding. Both treatments work by stopping blood cells called platelets from clumping together.
Plavix is one of the world's biggest ever drugs, with worldwide sales in 2007 of more than $8 billion.
Lilly is counting on prasugrel to help make up for expected plunging sales of several drugs set to lose U.S. patent protection in coming years, including its Zyprexa schizophrenia drug.
Daiichi and Lilly also announced they had started, as planned, another 10,000-patient clinical study called Trilogy to compare the effects of prasugrel against Plavix in patients with acute coronary syndromes.
John Alexander, Daiichi's global head of research and development, said the move demonstrated the companies' continued commitment to investigate the new medicine.
Lilly shares were down $1.41, or nearly 3 percent, at $46.19 in morning trading on the New York Stock Exchange, where they fell as low as $45.97. (Additional reporting by Lewis Krauskopf in New York) (Editing by Brent Kininmont, Quentin Bryar and Steve Orlofsky)
