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Lilly Reports Solid Second-Quarter 2009 Results, Raises EPS Guidance
Date:7/22/2009

. The company and its partner, Daiichi Sankyo, Inc., plan to launch Effient in the U.S. by early August.
  • The FDA approved Alimta((R)) as a maintenance therapy for locally advanced or metastatic non-small cell lung cancer (NSCLC), specifically for patients with a nonsquamous histology whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
  • The European Commission granted approval for the use of Alimta as monotherapy for maintenance treatment of patients with other than predominantly squamous cell histology in locally-advanced or metastatic NSCLC, whose disease has not progressed immediately following platinum-based chemotherapy.
  • Alimta received regulatory approval in Japan as both a first- and second-line treatment of NSCLC.
  • The company and its partners Amylin Pharmaceuticals, Inc., and Alkermes, Inc. submitted a New Drug Application (NDA) to the FDA for exenatide once weekly. Exenatide once weekly is an investigational sustained release medication for type 2 diabetes that is injected subcutaneously and administered only once a week.
  • The company resubmitted its supplemental New Drug Application (sNDA) for Cymbalta((R)) for the management of chronic pain to the FDA.
  • The U.S. District Court for the Southern District of Indiana issued a preliminary injunction to prevent the launch of a generic version of Evista((R)) by Teva Pharmaceuticals until the Court renders its final ruling.
  • The company began enrolling patients in two separate but identical Phase III clinical trials of solanezumab, an anti-amyloid beta monoclonal antibody being investigated as a potential treatment to delay the progression of mild to moderate Alzheimer's disease. The trials each include a treatment period that lasts 18 months and are expected to enroll a total of 2,000 patients age 55 and over from 16 countries.

    • Second-Q
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    SOURCE Eli Lilly and Company
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