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Another Lilly drug gets nod from FDA
Combo product used to treat patients with bipolar depression

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New from Lilly

Lilly’s five newest drugs, U.S. launch dates and their projected sales for 2006.

Strattera (attention deficit hyperactivity disorder):
Released: Jan. 2003
$625 million

Cialis (erectile dysfunction):
Released: Nov. 2003
$597 million

Xigris (severe sepsis):
Released: Nov. 2001
$423 million

Symbyax (bipolar depression):
To be released in Jan. 2004
$338 million

Forteo (osteoporosis):
Released: Dec. 2002
$200 million

Source: Merrill Lynch sales projections
December 30, 2003

An Eli Lilly and Co. drug to treat bipolar depression has been approved for sale by the Food and Drug Administration, the third product approval of the year for the drugmaker.

Lilly said Monday that Symbyax should show up in U.S. pharmacies in two to three weeks.

Symbyax becomes the first FDA-approved drug for the depression phase of bipolar disorder, a hard-to-treat mental illness with debilitating mood swings ranging from deep depression to abnormal elation.

Symbyax pairs two Lilly drugs, Prozac and Zyprexa, in one pill.

By combining them, "there's a synergy effect beyond what you expect" from taking the drugs separately, said Dr. Robert W. Baker, associate medical director for U.S. neurosciences at Lilly.

He said Lilly studies show Symbyax is effective in easing symptoms of depression in up to 60 percent of bipolar patients without pushing them into mania, which happens as much as half the time when antidepressants alone are given.

In one eight-week Lilly study, only 5 percent of patients taking Symbyax for bipolar depression swung into the manic phase, Baker said.

When effective, Symbyax "lifts the depression and gets to the middle zone you're shooting for rather than breaking through into mania," he said.

Zyprexa, Lilly's current best-seller, is approved for schizophrenia and acute mania in bipolar disorder. Prozac, Lilly's previous No. 1 drug, is an antidepressant.

Symbyax isn't expected to be a blockbuster drug for Lilly, in part because the antidepressant market is highly competitive. The investment firm Merrill Lynch projects the drug's annual sales could hit $338 million by 2006. At least eight other Lilly drugs likely would have higher sales by then.

The Indianapolis drugmaker began studying the Prozac-Zyprexa combination after learning that some psychiatrists on their own were experimenting with prescribing both drugs for their patients.

"My expectation is that Lilly will market this combination pill very strongly," Robert Hirschfeld, chairman of the department of psychiatry at University of Texas Medical Branch, told Bloomberg News.

The starting dose of the pill contains 25 mg of fluoxetine, the active ingredient in Prozac, and 6 mg of olanzapine, the active ingredient in Zyprexa. Prozac's normal starting dose is 20 mg, while Zyprexa's is 5 mg to 10 mg, said Lilly spokeswoman Marni Lemons.

She said Symbyax, which is taken once a day, will be sold to wholesalers at the same price as Zyprexa alone. Zyprexa can cost $10 a pill at retail prices. The new drug also is cheaper than taking Prozac and Zyprexa separately, because a patient with health coverage will incur only one insurance co-payment rather than two, she said.

More than 2.5 million Americans are diagnosed with bipolar disorder. Typically, they spend three times longer in the depressive phase than the manic phase. One in four people with the illness attempts suicide.

The most common adverse side effects from Symbyax are drowsiness, weight gain, increased appetite and feeling weak. Zyprexa and other newer antipsychotics have been linked to hyperglycemia, or increased blood-sugar levels, so patients with diabetes who take Symbyax should have their blood sugar monitored, Lilly said.

Symbyax's approval marks the end of one of the most fruitful years for new product approvals at Lilly. The FDA approved Lilly's male sexual dysfunction drug, Cialis, in November and gave the nod in July to expanded use of the growth hormone Humatrope for children of short stature.

Lilly makes Symbyax in Puerto Rico, where Zyprexa also is manufactured.

Lilly's stock price rose $1 a share on Monday to $71.62.

Call Star reporter Jeff Swiatek at 1-317-444-6483.

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