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Lilly Highlights Transformation Strategy for Wall Street, Reviews Robust Pipeline and Sets 2009 Financial Guidance
Date:12/11/2008

naged ACS patients. TRILOGY will include approximately 10,000 patients at more than 800 hospitals in 35 countries and is structured as a superiority trial against clopidogrel. Since December, 2007, several follow-on data analyses of the TRITON TIMI-38 study have been published and presented regarding secondary endpoint data and data on relevant patient subpopulations. These include analyses of stent thrombosis, recurrent cardiovascular events and prasugrel's use in patients with either diabetes or STEMI (ST-Segment Elevation Myocardial Infarction).

-- Arzoxifene - A five-year Phase III study, GENERATIONS, that enrolled more than 9,000 patients is expected to be completed in 2010. Two additional Phase III trials, FOUNDATION and NEXT, have already completed. The company expects to submit a New Drug Application (NDA) to the FDA in the fourth quarter of 2009. The submission will seek approval for three indications in postmenopausal women - treatment of osteoporosis, prevention of osteoporosis and reduction of risk of invasive breast cancer.

-- Exenatide once weekly - The company continues to develop exenatide once weekly with its partners, Amylin Pharmaceuticals, Inc. and Alkermes, Inc. During 2008, the partners made significant progress toward commercialization of the molecule. A pre-NDA meeting was held with the FDA, commercial-scale production was begun at Amylin's Ohio facility, and the FDA has agreed to accept data from the DURATION-1 trial as an appropriate way to demonstrate comparability between clinical trial scale and commercial scale material from the Ohio facility. The companies anticipate regulatory submission to the FDA by the end of the first half of 2009. European regulatory submission is expected in late 2009.

-- Olanzapine long-acting injection - The European Commission recently approved Zypadhera(TM), the company's long-acting injectable formulation of Zyprexa(R). Zypadhera is approved
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