Shares of Eli Lilly and Co. and its partner Amylin Pharmaceuticals Inc. rose in pre-market trading on hopes that the companies’
new version of diabetes treatment Byetta will be approved following U.S. regulators’ clearance of a similar drug.
The U.S. Food and Drug Administration on Monday approved Victoza, a drug developed by Denmark-based Novo Nordisk A/S to compete against Byetta. Victoza is a once-daily shot, compared with the twice-daily Byetta.
But Indianapolis-based Lilly and San Diego-based Amylin have asked the FDA to approve a once-weekly version of Byetta, which would be the most convenient for patients. Analysts expect sales of once-weekly Byetta to reach as high as $2 billion by 2015, which would be split by Lilly and Amylin. Sales of twice-daily Byetta last year were on pace to reach about $790 million.
What’s been holding up Victoza and the once-weekly Byetta have been regulator concerns about patients developing inflammation of the pancreas while taking the drugs.
In approving Victoza, the FDA required its label to carry a warning about pancreatitis as well as a prohibition against use in patients at risk for a rare thyroid cancer after tumors developed in rodents.
Those warnings were milder than many analysts had feared.
“Given the fact that the FDA has clearly been agonizing over whether to approve this or not, it isn’t bad,” said Jack Scannell, an analyst at Sanford C. Bernstein Ltd. in London, who estimates Victoza could generate $900 million in annual sales by 2015.
Other analysts’ said the FDA’s decision on Victoza makes it likelier to approve once-weekly Byetta under the same terms.
“We continue to believe that Byetta LAR will receive the same treatment from the FDA” as Victoza, wrote analyst Joshua Schimmer of Leerink Swann, in a note to clients today.
Yaron Werber of Citigroup, wrote in a report to clients today, that the FDA is due to make a decision on once-weekly Byetta by March 5.
In morning trading, Amylin and Novo both saw their stock prices jump. Amylin shares rose as high as 14.5 percent and Novo shares surged as much as 4 percent. Lilly's stock price rose as much as 1 percent, to $36.14.