Amylin signs weight-loss drug deal with Takeda

NEW YORK - Amylin Pharmaceuticals Inc. says it could potentially receive more than $1 billion from a partnership with Japan's Takeda Pharmaceutical Co. on potential weight-loss treatments.

Company shares climbed nearly 10 percent in trading Monday, despite an announcement that government regulators strengthened warning labels on company's diabetes treatment Byetta.

The Food and Drug Administration highlighted bolstered language about kidney damage on the drug's labeling.

Amylin, based in San Diego, said late Sunday it will receive $75 million upfront from Takeda and said future payments for development and achieving commercial milestones could top $1 billion.

The deal includes two potential weight-loss treatments, a pramlintide-metreleptin combination and davalintide. Both potential drugs are in midstage, or Phase II, clinical development. In July, Amylin said pramlintide-metreleptin prompted an average weight loss of 22 pounds, or 11 percent of patients' body weight, during a midstage study.

The deal also includes additional compounds from both companies research programs. Aside from milestone payments, Amylin is also eligible for royalties on global sales.

Its shares rose $1.09, or 9.9 percent, to close at $12.13 Monday.

Amylin is responsible for developing potential products through midstage development, while Takeda will take over late-stage development, along with all development activities outside the U.S.

Amylin estimates it will be responsible for 20 percent of development costs for obtaining approval for products in the U.S.

Leerink Swann Research analyst Dr. Joshua Schimmer reaffirmed a "Market Perform" rating for Amylin, saying the obesity drug deal will help reduce future expenses. He said Amylin costs for obesity drugs represented about 13 percent of second-quarter research and development costs.

On Friday, Amylin said the FDA expanded approval of Byetta as a stand-alone diabetes treatment. Previously, it was approved for use in combination with other diabetes drugs.

Schimmer said there will likely be little change in how physicians prescribe Byetta following the expanded approval, saying doctors have already been prescribing the drug off-label as a stand-alone therapy.

The FDA also strengthened warning language on Byetta, following more than 60 reports of kidney failure with the drug between April 2005 and October 2008.

While the previous label mentioned such side effects, the new language specifies that doctors should not prescribe Byetta to patients with severe kidney problems. The FDA did not put the warning in a so-called "black box," a move that could have raised safety concerns among doctors.

"In our view these developments are in line with expectations and we do not expect any impact to Byetta sales as pancreatitis was first added as a precaution on the label in October 2007," wrote Lazard Capital Markets analyst Michael O'Brien, in a note to investors.

The Amylin-Takeda deal comes amid a surge in obesity treatment research and development from the biotechnology industry. Several companies already have their potential drugs in late-stage development, setting the stage for a competitive market if each gains Food and Drug Administration approval.

In October, several companies reported positive updates to their studies at the annual scientific meeting of The Obesity Society in Washington DC.

Vivus Inc. said patients taking its potential weight-loss drug Qnexa lost about 11 percent of their body weight. Arena Pharmaceuticals Inc. said patients taking lorcaserin lost 31 percent of their excess body weight in the first year of a two-year study. Earlier this year, Orexigen Therapeutics Inc. reported results showing that Contrave patients lost more than 8 percent of their weight.

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