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SAN DIEGO (
Amylin Pharmaceuticals(AMLN) concealed a study from the U.S. Food and Drug Administration that raised heart safety concerns about its diabetes drug Byetta and then hindered FDA access to the data when the agency discovered its existence, newly released FDA records show.
Later, Amylin executives lied to investors by failing to disclose that this hidden Byetta heart-safety study played a key role in FDA rejecting the company's follow-on diabetes drug Bydureon, according to these same FDA records.
The allegations that Amylin stonewalled FDA about the heart safety of its diabetes drugs and then misled investors about the issue come as the company is said to be seeking a Big Pharma buyer after turning down an unsolicited offer from
Bristol-Myers Squibb(BMY - Get Report).
Amylin shares are up 154% this year, the stock's highest level in four years, on speculation about a takeover despite a slow commercial launch of Bydureon, which FDA eventually approved in January after two rejections.
AstraZeneca(AZN - Get Report),
Sanofi(SNY - Get Report),
Takeda have reportedly submitted bids or are considered making a bid for Amylin, according to various unconfirmed media reports.
The review and approval of Bydureon was a "long and complicated process, in part due to Amylin's withholding of information on Byetta that FDA deemed to be important to its evaluation of the safety and effectiveness of Bydureon," according to a
memo written by Mary Parks, division director of the FDA responsible for the review and oversight of diabetes drugs. Parks wrote the memo in January 2012 after Bydureon was approved but was only recently
posted to the FDA's web site alongside additional disclosures about the Bydureon review process.
"Amylin is committed to being transparent with regulatory agencies, the patients and physicians who put their trust in our products, and our investor community," said company spokeswoman Alice Izzo Friday in response to questions about the FDA memo. "Our interactions with regulatory agencies have been, and will continue to be, forthright and timely. Throughout the Bydureon review process, Amylin responded appropriately to requests for additional data."
Amylin has been selling Byetta since 2005 but the drug is relatively inconvenient because diabetics must inject themselves twice per day. To improve convenience and boost sales, Amylin developed Bydureon, which uses the same drug ingredient as Byetta but is formulated with technology from
Alkermes(ALKS - Get Report) so that patients require only one injection per week.