Amylin Pharmaceuticals, Inc. (MM) (NASDAQ:AMLN)
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Amylin Pharmaceuticals Inc. (AMLN) Chief Executive Daniel Bradbury said the drug maker can withstand the recent setback it suffered when U.S. regulators declined to approve its proposed diabetes drug Bydureon.
In an interview Tuesday evening on the sidelines of the Cleveland Clinic's Medical Innovation Summit, Bradbury said the company's near-term strategy is to maximize revenue from its existing diabetes drugs Byetta and Symlin, while working to persuade the U.S. Food and Drug Administration to clear Bydureon as quickly as possible.
"We're confident in Bydureon and our ability to get Bydureon to the market," Bradbury said. "And it's something that we are very committed to ensuring will happen in the shortest possible time, while recognizing we need to work with the FDA to make that happen."
Bydureon is a long-acting version of Byetta that can be injected once weekly, as opposed to twice daily for the typical Byetta user. Analysts have predicted Bydureon could generate sales of $1 billion to $3 billion annually. Amylin has developed Bydureon in partnership with Eli Lilly & Co. (LLY) and Alkermes Inc. (ALKS).
But on Oct. 19, the FDA declined to approve Bydureon, instead sending a letter asking for a new study to test the effect of a high dose of the drug on heart rhythm. The drug's co-developers said they expected to submit the results of such a study to the FDA by the end of 2011, which essentially pushes back the agency's potential clearance of the drug to 2012 at the earliest.
Amylin shares are off more than 35% since the FDA's rejection of Bydureon, closing Tuesday at $13.10, as investors worried the delay could strain Amylin's financial resources.
Bradbury said the setback will not prompt any major changes in the way the company does business, though he did say Amylin would continue to try to operate as efficiently as possible--hinting cost cuts might be on the table.
He said he's confident in Amylin's financial position and its ability to meet short-term debt obligations.
San Diego-based Amylin also has a financial backstop from partner Lilly if necessary: Lilly previously agreed to loan Amylin up to $165 million. Amylin hasn't borrowed anything from Lilly under this agreement, and Bradbury said Tuesday "at this time we have not made any decision with regard to the Lilly loan."
The new study requested by the FDA is "unlikely to be a very large study," and Bradbury said the cost "is probably not going to be huge," though he declined to discuss specifics. He said the company must firm up the design of the study with the FDA.
Amylin first began working on Bydureon in 1999, Bradbury said. To hit a significant delay in bringing it to market 11 years later is "very frustrating," he said.
"It's a challenging environment for innovators, but it's also a challenging environment for regulators" due to the public's low tolerance for drug risks, he said.
Some analysts have speculated that Lilly might acquire Amylin, or at least a minority stake, in the wake of the Bydureon setback.
Asked about such speculation, Bradbury said: "We believe at the moment the best way to increase shareholder value is by driving revenue from Byetta and Symlin and getting Bydureon to market in as short amount of time as possible."
The company is scheduled to report third-quarter results on Thursday.
-Peter Loftus, Dow Jones Newswires; +1-215-656-8289; firstname.lastname@example.org