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Lilly Reports Third-Quarter 2011 Results
Date:10/20/2011

als, Inc. and Alkermes, Inc., submitted a reply to a complete response letter issued in October 2010 by FDA regarding Bydureon™, an investigational medication for type 2 diabetes. The FDA has assigned a new Prescription Drug User Fee Act (PDUFA) action date of January 28, 2012.
  • The company submitted its reply to a complete response letter by FDA regarding Amyvid™, a molecular Positron Emission Tomography (PET) imaging agent under investigation for the detection of beta-amyloid plaque in the brains of living patients.

  • The America Invents Act was signed into law, aligning new U.S. patent laws more closely with those from other countries and improving the global competiveness of U.S. innovator companies such as Lilly. The law will provide new advantages for U.S. inventors by streamlining the application process and addressing the backlog of current applications. This new law, which transitions the U.S. from a "first-to-invent" to a "first-inventor-to-file" system, is the most significant overhaul of the U.S. patent system in 175 years.

  • Third-Quarter Reported Results

    In the third quarter of 2011, worldwide total revenue was $6.148 billion, an increase of 9 percent compared with the third quarter of 2010. This 9 percent revenue growth was comprised of increases of 4 percent in volume and 4 percent due to the impact of foreign exchange rates. Price had a negligible impact on revenue growth, reflecting the loss of U.S. patent exclusivity for Gemzar® in November 2010. Total revenue in the U.S. increased 4 percent to $3.273 billion due to higher prices and increased volume. Total revenue outside the U.S. increased 15 percent to $2.874 billion due to the positive impact of foreign exchange rates and increased volume. Third-quarter 2011 total revenue was reduced by approximately $130 million due to the impact of U.S. health care reform.

    Gross margin increased 3.1 percent to $4.810 billion in the third quarte
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    SOURCE Eli Lilly and Company
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