In latest R&D setback, Lilly's schizophrenia drug flunks a PhIII

Eli Lilly's ($LLY) attempt to develop a new schizophrenia drug that skirts the serious side effects of Zyprexa--while replacing the blockbuster cash the pharma giant is losing to generic competition--has run into a major roadblock. The company says that Pomaglumetad Methionil (once referred to as LY2140023) failed to hit the primary endpoint for either the overall population or a genetic subpopulation in Phase III. A second Phase III study is underway, with interim data expected later in the year.

Lilly officials quickly sought to downplay the late-stage failure, one in a series of clinical pratfalls which has helped blight its reputation and raised serious questions about CEO John Lechleiter's insistence that the company will avoid the kind of large buyouts that have become routine in the industry. But Lilly once touted the schizophrenia program as a possible blockbuster, relying on a new pathway to open a fresh approach to treating schizophrenia without the weight gain or raised lipid levels which bedeviled Zyprexa users.

"Unfortunately negative studies are common in the field of psychiatry and a reality of biopharmaceutical innovation," said Jan Lundberg, president of Lilly Research Laboratories. "Despite all of the advances, the need for new and better treatments for those suffering with mental illnesses is among the most urgent in medicine.  Lilly has long been a pioneer in neuroscience, and we're committed to discovering and delivering breakthrough treatments that make a difference for patients. "

Lundberg is right about the risky nature of neuroscience programs. GlaxoSmithKline ($GSK)--and others--swore off R&D work on some high-risk areas of neuroscience drugs, including schizophrenia. Lilly's biggest gamble this year is on a late-stage program for its Alzheimer's drug. And its woeful R&D record along with big questions over its study design and uncertainties over what triggers the disease have conspired to raise enormous skepticism about its chances of success.

Today's news won't do anything to improve those odds.

- here's the press release
- read the Reuters story

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