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Lilly Reports Strong First-Quarter 2009 Results
Date:4/20/2009

the company's patent litigation for Evista. A temporary restraining order currently prohibits the launch of a generic version of Evista by Teva Pharmaceuticals. The company expects a ruling on a preliminary injunction motion by April 23, 2009. If granted, the preliminary injunction would enjoin Teva from launching prior to a final ruling.
  • The FDA approved a new indication for Symbyax(R) for the acute treatment of treatment-resistant depression (TRD) in adults.
  • The FDA approved two new combination indications for Zyprexa(R) (olanzapine) and fluoxetine for the acute treatment of bipolar depression and TRD in adults.
  • The company received a complete response letter from the FDA for the first-line squamous cell carcinoma of the head and neck (SCCHN) supplemental Biologics License Application (sBLA) for Erbitux(R).
  • The company submitted a reply to the FDA regarding the agency's complete response letter for Zyprexa long-acting injection. The company also launched this product under the tradename Zypadhera(TM) in several countries within the European Union.

    • First-Quarter Significant Items Affecting Reported Net Income

    There were no significant items affecting net income in the first quarter of 2009; however, the reported earnings per share for the first quarter of 2008 were favorably affected by significant items netting to $.05 per share. To reflect the impact of the ImClone acquisition as if the acquisition occurred in January 1, 2008, first quarter 2008 pro forma earnings per share have been reduced by $.04 per share. These items are summarized below and in the table that follows:

    2008

    • The company recognized a charge of $145.7 million, or $.09 per share, for asset impairments, restructuring and other special charges primarily related to the termination of the AIR(R) Insulin program.

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    SOURCE Eli Lilly and Company
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