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

circa(TM). In October, Lilly received PAH approval in Japan, where it has partnered with Nippon Shinyaku. In November, Lilly received PAH approval in Europe and Canada. Lilly maintains full rights to the PAH indication in all markets outside of the U.S. and Japan. The BPH Phase III program is ongoing and will complete recruitment late next year. The company expects to submit for approval of the BPH indication in the U.S. and Japan in 2011, and in the EU in 2012.

With the launches of Effient in the U.S. and Europe earlier this year for treatment of patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI), the company is optimistic about its potential in this important market segment. In the U.S., Lilly and Daiichi-Sankyo launched Effient in early August and are diligently executing sales and marketing plans to gain payer and hospital formulary access. Outside the U.S., Lilly and Daiichi Sankyo launched Efient in Germany and the U.K. in April 2009. The companies anticipate launches in France, Italy and Spain in 2010. Lilly has also launched Efient in Australia and Argentina, and anticipates launching the medicine in 24 additional countries outside of the U.S. and Europe in 2010. Lilly and Daiichi-Sankyo are also pursuing additional ongoing studies, including the TRILOGY ACS study in medically managed patients.

Key molecules in the established markets business unit pipeline include:

  • Semagacestat - This gamma secretase inhibitor is currently being studied in two large multi-national pivotal Phase III trials - IDENTITY and IDENTITY-2 - to assess its effect on the progression of Alzheimer's disease. Enrollment in the IDENTITY trial was completed in the third quarter of 2009 and includes over 1,500 patients in 20 different countries. Enrollment in IDENTITY-2 is progressing rapidly and is expected to be completed in the first half of 2010.
  • Solanezumab - A monoclonal antibo
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