Ebb & Flow

Shares of Amylin Pharmaceuticals Inc. (NASDAQ:AMLN) rode a rollercoaster last week, ultimately finishing down $2.32 (19%) to $9.68, on a mix of clinical, corporate and competitor news.

On Monday, the stock was off by as much as 9% to $10.87 intraday after Amylin announced the nomination of two new board members in its ongoing battle with activist investor Carl Icahn.

The following day the stock hit an intraday high of $13.45 - up 19% on Monday's close of $11.32. The company's exenatide once weekly met the primary endpoint in the Phase IIIb DURATION-2 trial to treat Type II diabetes (see B14).

Also on Tuesday, FDA released briefing documents for an FDA panel review of competing Type II diabetes treatment Victoza liraglutide from Novo Nordisk A/S (CSE:NVO; NYSE:NVO).

News on Wednesday that Amylin and Lilly received rights from Altea Therapeutics Corp. to use the latter's PassPort Transdermal Delivery System to develop a transdermal version of exenatide had no effect on the stock. Altea recently completed a Phase I study of the once daily patch for Type II diabetes (see B2).

But Amylin's shares fell on Thursday and Friday after the FDA panel discussed data regarding a preclinical thyroid cancer signal in Victoza and whether it could be a class effect for long-acting GLP-1 agonists, which includes exenatide once weekly (see "Victoza Rat's Nest," A5).

Amylin and partner Eli Lilly and Co. (NYSE:LLY) expect to submit an NDA for exenatide once weekly by the end of next quarter. The long-acting release formulation of synthetic exendin-4 uses Medisorb drug delivery technology from Alkermes Inc. (NASDAQ:ALKS), which was off $2.61 (22%) to $9.49 on the week.

Bulging ballot

Meanwhile, the battle for control of Amylin's board became more convoluted. The company has tentatively scheduled its 2009 annual meeting for May 27, where shareholders could face a total of 22 possible directors for the 12-member board.

The outcome could be clouded by change of control provisions in two debt agreements. If a majority of Amylin's board changes, that could trigger a wave of debt repayments totaling more than $900 million. Amylin, with a current market cap of $1.3 billion,

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