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Amylin's Diet Drug Crumbles

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There's yet another safety concern over an obesity treatment: Amylin and Takeda suspend human testing.

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Amylin Pharmaceuticals (AMLN) halted human studies of an obesity treatment due to a safety concern, raising questions about future revenue growth and further highlighting the difficulty of developing diet drugs.

The company and development partner Takeda Pharmaceutical of Japan were testing two synthetic hormones, pramlintide and metreleptin, in the second of three groups of studies usually needed for US approval. The trial was stopped but the companies are saying little about why. The only detail: researchers discovered an "antibody-related laboratory finding" with metreleptin treatment in a couple of patients in an earlier study.

"The safety of patients in our clinical programs is of paramount concern to the companies," Amylin Chief Medical Officer Orville Kolterman says in a statement. "We have taken this precaution so that we can thoroughly investigate this finding."

Shares of Amylin fell early but recovered and were trading up 1% to $11.14 in late-morning trading Wednesday. They have declined 24% so far this year.

Kolterman adds that the company will work with researchers and the Food and Drug Administration "to determine the best path forward."

We already know that the FDA is skeptical of diet drugs and expresses great concern about their safety. Orexigen Therapeutics (OREX), Vivus (VVUS) and Arena Pharmaceuticals (ARNA) all applied to sell their obesity drugs in the US last year only to be rejected. The FDA asked each company to prove the safety of their products before it will reconsider approval.

Despite an obesity crisis in the US that's leading to increased risk of heart attacks, diabetes and other diseases, the FDA doesn't view diet pills as serving an unmet need. And mishaps with other diet drugs have left US regulators feeling snakebit. Abbott Laboratories (ABT) pulled its diet drug Meridia from the US market due to safety concerns last year after selling it for more than a decade.

So Amylin's decision to shut down a diet pill program may not be the worst thing for investors. But it's a setback, nonetheless. Some analysts saw this drug as possibly the next wave of revenue growth for the company.

The company highlights the program in its annual report filed with the Securities and Exchange Commission.

"Our long-term growth strategy is focused on making prudent investment decisions based on positive clinical data to advance our obesity program, including the development of pramlintide/metreleptin," the company says in its securities filing.

Leerink Swann analyst Joshua Schimmer recently called it a "hidden" and under-appreciated opportunity for Amylin.

Amylin notes that today's announcement doesn't affect another study of metreleptin to treat lipodystrophy, a rare metabolic condition.

Today's news marks the second disappointment this month for Amylin, however. On March 3 the company and partner Eli Lilly (LLY) said that the experimental drug Bydureon for diabetics was less effective in a study compared with Novo Nordisk's already-approved Victoza. (See Amylin's Bydureon Bombs)

Amylin and Lilly plan to apply for approval of Bydureon later this year. While the comparative study shouldn't affect the FDA's decision to approving Amylin's drug, it may hamper sales in a competitive market in which Victoza has an early lead.


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No positions in stocks mentioned.
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