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Re: DewDiligence post# 123544

Monday, 07/18/2011 7:11:15 PM

Monday, July 18, 2011 7:11:15 PM

Post# of 252271
Teva has 2 Neulasta knock-offs in the works, one of which came with the ratiopharm acquisition. Here's the recent PR on the Phase III trial for XM22:

http://www.tevapharm.com/pr/2011/pr_1018.asp

Teva Announces Successful Results of Phase III Study of Its Long-Acting G-CSF Product (Lipegfilgrastim) in Breast Cancer Patients
Jerusalem, Israel, June 6, 2011 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that lipegfilgrastim (INN; internal code - XM22) achieved its primary endpoint of reducing the duration of severe neutropenia in a Phase III study designed to evaluate the efficacy and safety of lipegfilgrastim (XM22) compared to pegfilgrastim (Amgen's Neulasta™).

Lipegfilgrastim (XM22), a long acting granulocyte colony-stimulating factor (G-CSF), was added to Teva's portfolio through the acquisition of ratiopharm. It is being developed to reduce the duration of severe neutropenia in cancer patients undergoing chemotherapy. Neutropenia is a condition in which the number of white blood cells is decreased, leaving patients more susceptible to potentially life-threatening bacterial infections.
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I do not know whether Amgen's Neulasta patent would be infringed by XM22 on account of its pegylation. Obviously, Neugranin, which is albumin based, will be non-infringing.

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