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Lilly Outlines Innovation Strategy, Reviews Promising Pipeline of Potential Medicines and Sets 2010 Financial Guidance
Date:12/10/2009

its partners, Amylin Pharmaceuticals, Inc. and Alkermes, Inc. The companies submitted exenatide once weekly for U.S. regulatory review in the second quarter of 2009. The application was accepted for review by the FDA in the third quarter of 2009. Regulatory action is expected by the end of the first quarter of 2010. European submission is expected to occur by the end of the second quarter of 2010.
  • GLP-Fc - An adaptive, seamless Phase II/III trial, comparing GLP-Fc with both placebo and a positive control, sitagliptin, is proceeding. The company is also finalizing its full Phase III clinical program, known as AWARD, and will begin enrolling patients in the first quarter of 2010. To address the recent FDA guidance regarding mitigation of cardiovascular (CV) risk, a large CV outcomes trial is planned that will likely begin in the first quarter of 2011. Based on the company's current expectations, GLP-Fc could be submitted for U.S. regulatory review as early as late-2012.
  • Teplizumab- The safety and efficacy of teplizumab is currently being studied in both children and adults with newly-diagnosed type 1 diabetes mellitus in two global, pivotal Phase III clinical trials - Protégé and Protégé Encore. The Protégé trial completed enrollment in 2009. Patients who have completed the two-year protocol are currently transitioning into an extension phase evaluating the long-term safety and durability of teplizumab. Protégé Encore, the second global pivotal Phase III clinical trial began enrolling patients in June 2009. Regulatory submission could occur in 2012.
  • Emerging Markets

    The emerging markets business unit will include many of the world's fastest-growing markets, including six of the so-called "pharmerging markets" - China, Russia, Brazil, Mexico, South Korea, and Turkey. Lilly aims to increase its presence in these countries and others where strong growth rate
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