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Lilly Reports Fourth-Quarter and Full-Year 2008 Results
Date:1/29/2009

taneous coronary intervention (PCI). The CHMP positive opinion is now referred for final action to the European Commission.

-- Olanzapine long-acting injection was approved by the European Commission under the trade name Zypadhera(TM).

-- The company received a complete response letter from the FDA for olanzapine long-acting injection for acute and maintenance treatment of schizophrenia in adults. Lilly is continuing to work with the agency on the new drug application (NDA). The FDA does not require any additional clinical trials for the continued review of the NDA. Per the agency's request, the company is preparing a proposed Risk Evaluation and Mitigation Strategy (REMS), which will be submitted in the near future.

-- The company withdrew its supplemental New Drug Application (sNDA) from the FDA for Cymbalta for the management of chronic pain. The company plans to resubmit the application in the first half of 2009, adding data from a recently completed study in chronic osteoarthritis pain of the knee.

-- The company entered into a license and supply arrangement with United Therapeutics Corporation related to the U.S. commercialization rights for the pulmonary arterial hypertension (PAH) indication of tadalafil. The indication is currently under review by the FDA.

-- The Federal Supreme Court (BGH) in Germany re-established the company's Zyprexa patent that had been declared invalid in 2007 by the German Federal Patent Court. As a result of this ruling, generic olanzapine has been withdrawn from the German market.

Fourth-Quarter Significant Items Affecting Reported Net Income (Loss)

The reported results for the fourth quarters of 2008 and 2007 were affected by significant items totaling $4.38 and $.12 per share, respectively, which are summarized below and in the table that follows:

2008

-- The company recognized pr
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SOURCE Eli Lilly and Company
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