naged ACS patients. TRILOGY will include approximately 10,000
patients at more than 800 hospitals in 35 countries and is structured as a
superiority trial against clopidogrel. Since December, 2007, several follow-on
data analyses of the TRITON TIMI-38 study have been published and presented
regarding secondary endpoint data and data on relevant patient subpopulations.
These include analyses of stent thrombosis, recurrent cardiovascular events
and prasugrel's use in patients with either diabetes or STEMI (ST-Segment
Elevation Myocardial Infarction).
-- Arzoxifene - A five-year Phase III study, GENERATIONS, that enrolled
more than 9,000 patients is expected to be completed in 2010. Two additional
Phase III trials, FOUNDATION and NEXT, have already completed. The company
expects to submit a New Drug Application (NDA) to the FDA in the fourth
quarter of 2009. The submission will seek approval for three indications in
postmenopausal women - treatment of osteoporosis, prevention of osteoporosis
and reduction of risk of invasive breast cancer.
-- Exenatide once weekly - The company continues to develop exenatide once
weekly with its partners, Amylin Pharmaceuticals, Inc. and Alkermes, Inc.
During 2008, the partners made significant progress toward commercialization
of the molecule. A pre-NDA meeting was held with the FDA, commercial-scale
production was begun at Amylin's Ohio facility, and the FDA has agreed to
accept data from the DURATION-1 trial as an appropriate way to demonstrate
comparability between clinical trial scale and commercial scale material from
the Ohio facility. The companies anticipate regulatory submission to the FDA
by the end of the first half of 2009. European regulatory submission is
expected in late 2009.
-- Olanzapine long-acting injection - The European Commission recently
approved Zypadhera(TM), the company's long-acting injectable formulation of
Zyprexa(R). Zypadhera is approved Page: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Related biology technology :1
. Emisphere Technologies, Inc. and Eli Lilly and Company Settle Ongoing Litigation2
. Lilly Declares Fourth-Quarter Dividend3
. Robert Conley, M.D. to Join Lilly; Will assume a neuroscience leadership role as a Distinguished Lilly Scholar4
. Lilly and BioMS Medical Announce Global Licensing and Development Agreement5
. Daiichi Sankyo, Lilly Submit New Drug Application for Investigational Antiplatelet Drug, Prasugrel, with U.S. Food and Drug Administration6
. In response to a New England Journal of Medicine article published yesterday and subsequent media coverage, Eli Lilly and Company issued the following statement:7
. Lilly Announces Termination of AIR Insulin Program8
. HistoRx and Lilly Extend, Expand AQUA(R) Analysis Partnership9
. Pelikan Technologies and Lilly Form Alliance to Promote Diabetes Education10
. Lilly Reports Solid First-Quarter Results11
. Lilly CEO Praises Massachusetts Leadership in Biotech, Urges Policy Prescriptions to Help Ensure States Investment Generates Dividends and Jobs