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

in Europe for maintenance treatment of adult patients with schizophrenia who are sufficiently stabilized during acute treatment with oral Zyprexa. In the U.S., the company has submitted a complete response to the FDA's not approvable letter and is currently awaiting the FDA's final review.

-- Gamma Secretase Inhibitor - In March 2008, the company began its first pivotal trial in Alzheimer's disease for the gamma secretase inhibitor, a small molecule designed to reduce the levels of the amyloid beta peptide in the brain. The trial, called IDENTITY, is actively enrolling and is ahead of schedule. A second pivotal trial, IDENTITY 2, was started in September 2008 and is also enrolling at a better-than-expected rate. Approximately 400 subjects have now been randomized in the two studies.

-- A-beta Antibody - A monoclonal antibody, the company's A-beta antibody offers the potential for slowing down the progression of Alzheimer's disease. It is expected to enter Phase III in 2009.

-- Enzastaurin - A Phase III clinical trial is currently under way for the use of enzastaurin as a maintenance therapy for diffuse large B-cell lymphoma. Because events are occurring at a slower rate than projected, the company is considering expanding enrollment and extending the trial. The company now expects U.S. regulatory submission to occur in mid-2013.

-- Teplizumab - The company continues to collaborate with its partner, MacroGenics Inc., on teplizumab, which is currently being studied in a pivotal Phase II/III clinical trial for Type 1 diabetes.

-- Dirucotide (MBP8298) - Along with its partner, BioMS, the company is studying dirucotide for the treatment of several types of multiple sclerosis (MS). There are two Phase III clinical trials ongoing targeting secondary progressive MS, one in Europe and Canada, and the other in the U.S. There is also a Phase II clinical trial underway in Europe for rel
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