In recent months, much of the attention on Amylin Pharmaceuticals Inc. has been focused on its highly publicized proxy fight and the push to get its once-weekly diabetes drug past regulatory muster. Far less attention has been paid to its obesity pipeline, which includes two mid-stage drugs with data due out this year.
Last week’s $1 billion co-development deal with Takeda Pharmaceutical Co., Asia’s biggest drug maker, serves as a reminder that Amylin is still in the running for capturing a significant share of the obesity markets, which some analysts estimate could top $2 billion.
Best-selling weight loss drug Xenical, made by Roche Holding AG, generated sales of $465 million last year, according to market research firm IMS Health. But if the FDA approves its first new prescription weight loss drug in a decade, the market potential for companies like Amylin is sky-high as statistics show the number of obese adults is growing at a rapid pace.
“Obesity is a complex disease likely requiring multiple treatment options,” said Amylin spokeswoman Anne Erickson. “We believe our peptide and multi-hormonal approach to developing obesity therapies has the promise to introduce effective medicines with strong safety profiles.”
Local competitors Arena Pharmaceuticals Inc. and Orexigen Therapeutics Inc., along with Vivus of Mountain View, will likely submit their weight loss drugs to the FDA first, but Amylin could raise the bar if it produces greater weight loss without harmful side effects seen in past obesity drugs. One of the experimental drugs included in the Takeda deal, a combination of Amylin’s diabetes drug Symlin and a form of leptin, a hormone implicated in weight loss, has already grabbed the attention of analysts and investors.
In a seven-month study of 608 obese patients, those taking the drug showed average weight loss of 11 percent, or 22 pounds, compared with 1.8 percent, or 4 pounds, in the placebo group. The most severely obese patients in the trial, however, did not see the same benefits.
The trial is ongoing, with data due out later this quarter. Amylin will also report data from a Phase 2 study of its other obesity drug, davalintide, a next generation form of Symlin, by the year’s end.
“The development strategy for each program will be determined by the outcome of these studies,” Erickson said.
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Delayed Dissolution: For the second time this year, a struggling San Diego biotech has failed to secure enough shareholder votes on its dissolution and liquidation plans.
Last week, La Jolla Pharmaceutical Co. said it would have to delay its special shareholders meeting until Nov. 6, the same day the company has indicated that Nasdaq could bump its listing off the market for failing to satisfy requirements. Only 7 percent of its shareholders returned proxy cards or voted by its Oct. 30 deadline. Dissolving the company requires a majority of outstanding voting shares for approval.
Torrey Pines Therapeutics experienced a similar situation this summer, rescheduling its meeting three times after shareholders failed to turn up. It later merged with Raptor Pharmaceutical Corp. of Novato.
If La Jolla Pharma succeeds in drumming up enough voter participation in the next round, the company could distribute any remaining cash to shareholders, to the tune of 2.8 cents to 4.5 cents a share. As of Aug. 31, La Jolla Pharma had $4.4 million cash, after subtracting liabilities and obligations.
