mylin Falls as Analyst Says FDA Wants Byetta Study (Update3)
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By Rob Waters
Dec. 23 (Bloomberg) -- Amylin Pharmaceuticals Inc. fell the most in more than eight months in Nasdaq trading after a Citigroup analyst said U.S. drug regulators are requiring more studies of the diabetes drug Byetta to assess its safety.
San Diego-based Amylin and Indianapolis-based Eli Lilly & Co., which co-market the drug, announced Oct. 30 that the Food and Drug Administration had cleared the drug for use as standalone therapy for Type 2 diabetics and that prescribing information would warn about the risk of pancreatitis, an inflamed pancreas, in patients with severe kidney disease. That statement didn’t say the FDA wanted more studies.
Citigroup analyst Yaron Werber said today in a note to investors that he had obtained a copy of the FDA’s approval letter and that the agency was requiring animal and human studies aimed at clarifying the risk of pancreatitis posed by the drug. A statement e-mailed by Lilly and Amylin today said most of the requested studies are under way and have shown no increased risk of pancreatitis in patients taking Byetta.
“The FDA considers post-marketing reports of acute pancreatitis (fatal and non-fatal hemorrhagic or necrotizing pancreatitis), acute renal failure and thyroid neoplasms as ‘new safety information’ and is requiring Amylin to conduct additional studies,” Werber said in his note.
Amylin dropped $1.48, or 9.6 percent, to $13.97 at 4 p.m. in Nasdaq Stock Market composite trading, the most since April 2. The shares have gained 29 percent this year.
Option Trading
Trading of bearish Amylin options jumped to a 15-month high as investors boosted bets that the shares will keep slumping over the next month. More than 31,400 put options giving the right to sell shares changed hands, about 14 times the four-week average and triple the number of calls to buy the stock. The most active were January $12.50 puts, which rose 146 percent to 37 cents and accounted for about a quarter of all put volume.
Byetta, a twice-daily injection, has been sold since April 2005 for patients taking other diabetes medications. In August 2008, the FDA and Amylin announced six patients taking Byetta had died from pancreatitis. A safety alert was issued by the FDA and Amylin said no evidence directly linked the drug to the deaths.
The companies, in their statement today, said they had been planning to conduct some of the studies requested by the FDA since pancreatitis emerged as a potential safety problem in 2007.
‘No Increased Risk’
“A well-powered, completed epidemiological study has shown no increased risk of pancreatitis in patients taking Byetta compared to patients taking other antidiabetic medications,” company spokeswoman Alice Izzo said in the statement. “This has been confirmed by an additional large epidemiological study utilizing a different database and different methodology.”
Amylin’s revenue from Byetta fell 5 percent to $171 million in the third quarter compared with the same period a year earlier, the company said Oct. 20 in a statement. Amylin and Lilly have been trying to gain U.S. approval for a once-weekly version of the medicine.
To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net.
