San Diego Life Sciences Roundup: Amylin Buyout, PDUFA, & More
Amylin’s acquisition topped the news out of San Diego’s life sciences sector in the week before the July 4 holiday. But there were plenty of other developments as well. Here’s my rundown:
—What a long, strange trip it’s been. San Diego’s Amylin (NASDAQ: AMLN) spent 18 years developing exenatide (Byetta), an injection that helps diabetics using insulin gain better control of their blood sugar. When the FDA approved the drug in 2005, then-CEO Ginger Graham celebrated by wearing a Snow White costume to the office and jumping into the reflecting pool outside Amylin headquarters with other senior executives. Last week, Amylin agreed to a $7.1 billion buyout offer from Bristol-Myers Squibb, which includes paying a $1.7 billion debt.
—In a bit of noteworthy timing, the FDA made public a memo that criticizes Amylin shortly before the Bristol-Myers Squibb deal was announced. The memo helps explain why it took so long for Amylin to win approval for its long-lasting version of exenatide, called Bydureon. The Street.com’s Adam Feuerstein broke the story about the memo authored by Mary Parks, the FDA division director responsible for diabetes drugs, who said Amylin withheld a study from U.S. regulators that raised heart safety concerns about exenatide. The Parks memo alleges that Amylin also hindered agency access to the data. An Amylin spokeswoman told TheStreet the company is committed to being transparent with regulators and others. Still, it’s apparent that regulators didn’t see it that way.
—The bill reauthorizing the Prescription Drug User Fee Act (PDUFA) is now awaiting President Obama’s signature. In passing the measure, Congress left plenty of time for the FDA to implement new programs before the existing prescription drug act’s authorization expires on September 30. One key provision of the legislation is entitled “Generating … Next Page »