Date:4/18/2011

pite a significant decline in Gemzar sales due to generic competition. This revenue growth allowed us to make necessary investments in research and development to address the challenges of upcoming patent expirations. We are on track to deliver on our 2011 headcount and expense reduction targets, as well as our goal of having at least ten potential new medicines in Phase 3 clinical development by the end of this year."

Key Events Over the Last Three Months

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval of exenatide 2 mg powder and solvent for prolonged release suspension for injection (proposed trade name Bydureon™) in the European Union for the treatment of type 2 diabetes in combination with certain oral therapies. The CHMP's positive opinion is now referred for final action by the European Commission, which has the authority to approve medicines for the European Union. The Commission usually makes a decision on CHMP recommendations within two to three months.

Late last week, the company received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for liprotamase, a non-porcine pancreatic enzyme replacement therapy (PERT), under investigation for the treatment of exocrine pancreatic insufficiency (EPI). The complete response letter communicated the need for Lilly to conduct an additional clinical trial prior to a re-submission. The company will be working diligently to address the agency's questions.

The company announced that Axiron® (testosterone) topical solution is available in pharmacies throughout the U.S.

The company received a complete response letter from the FDA for the NDA for Amyvid™ (florbetapir F 18 injection), a Positron Emission Tomography (PET) imaging agent under investigation for the detection of beta-amyloid plaque in the brain
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SOURCE Eli Lilly and Company Copyright©2010 PR Newswire. All rights reserved

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