Lilly Reports Solid First-Quart...(roduct but rather was a result of increa...)

uncertainties in the regulatory environment, and a thorough evaluation

of the evolving commercial and clinical potential of the product

compared to existing medical therapies.

-- The company received a not-approvable letter from the U.S. Food and

Drug Administration (FDA) for Zyprexa long-acting injection for the

treatment and maintenance treatment of schizophrenia in adults. In its

letter, the FDA said it needs more information to better understand the

risk and underlying cause of excessive sedation events that have been

observed in about 1 percent of patients in clinical trials.

-- The FDA accepted and gave priority review status to the New Drug

Application for prasugrel. The company, along with its partner Daiichi

Sankyo Company, Limited, is seeking FDA approval for prasugrel as a

treatment for patients with acute coronary syndrome being managed with

percutaneous coronary intervention. The company also recently submitted

prasugrel to the European Medicines Agency (EMEA) for the same

indication.

-- The European Commission approved a new indication for Forsteo(R) for

the treatment of osteoporosis associated with sustained, systemic

glucocorticoid therapy in women and men at increased risk for fracture.

The company has also received an approvable letter from the FDA for

Forteo for the same indication.

-- The company reached agreement with the state of Alaska to settle a

lawsuit filed by the state over use of Zyprexa by the state's Medicaid

program. The agreement includes no admission of wrongdoing on the

company's part.

-- The company entered into a licensing and collaboration agreement with

Transition Therapeutics Inc. granting Lilly exclusive worldwide rights

to develop and commercializ
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