Lilly gets narrow backing to expand Cymbalta

Eli Lilly (NYSE: LLY) got good news Thursday after an FDA expert panel voted eight to six in favor of expanding Cymbalta's indication to include certain chronic pain. And while the panel also advised the agency to approve Cymbalta as an additional treatment for low back pain, it recommended against expanding the indication to include osteoarthritis of the knee.

"Lilly is committed to helping people with unmet medical needs. For people living with chronic low back pain and chronic pain due to osteoarthritis, we believe it's important they have different treatment options available since responses to medications can be highly individualized," says Robert Baker, global development leader for psychiatry and pain disorders at Lilly, in a statement. "We see today's vote as an important step in potentially making Cymbalta available to a broader pain population."

The day's events brought encouraging news to the drugmaker, which had been enduring during what a Credit Suisse stock analyst has called Lilly's "summer of discontent," the Indianapolis Star notes. Earlier in the week, the company announced that it was halting all Phase III trials of semagacestat for Alzheimer's after preliminary results showed the drug did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living.

Catherine Arnold, analyst for Credit Suisse, said it was a "modest" victory for Lilly. "There was only support for expansion into the chronic low back pain indication and not for chronic pain due to osteoarthritis," she writes in an investor note, as quoted by the New York Times.

Bloomberg cites Seamus Fernandez, an analyst at Leerink Swann, as saying that annual sales of Cymbalta, the company's second-biggest medicine, may increase by more than $500 million, or 16 percent, with approval for the tens of millions of Americans with musculoskeletal pain.

Cymbalta made up 14 percent of Lilly's revenue in 2009, generating $3.07 billion in sales, Pharma Times notes. Patent protection is due to expire in 2013. Last December, a report named Lilly, along with AstraZeneca, and Bristol-Myers Squibb, as the companies facing the biggest patent losses over the next few years.

Separately, a federal judge temporarily blocked generic drug companies from selling their versions of Strattera, an ADHD treatment, according to the Indianapolis Star. The drug lost its patent protection in a court ruling last week.

- see the Lilly statement
- check out Bloomberg's coverage
- see the Indianapolis Star's take
- check out Pharma Times and its coverage
- get more from the NYT

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