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Re: DewDiligence post# 184267

Monday, 10/05/2015 1:26:44 PM

Monday, October 05, 2015 1:26:44 PM

Post# of 253148
MNTA/BXLT start phase-3 trial for Humira FoB:

http://finance.yahoo.com/news/baxalta-momenta-announce-initiation-pivotal-103000778.html

Baxalta Incorporated and Momenta Pharmaceuticals, Inc. today announced the initiation of a pivotal clinical trial in patients with chronic plaque psoriasis for M923, a biosimilar version of HUMIRA (adalimumab).

The trial is a randomized, double blind, active control, multi-center, global study in patients with chronic plaque psoriasis to compare the safety, efficacy and immunogenicity of M923 with HUMIRA. The companies are targeting first regulatory submission in 2017 and a first commercial launch in 2018.

M923 is the sole remaining program from MNTA’s FoB collaboration with BXLT. MNTA is seeking another partner for a broad-based FoB development program and has guided investors to expect an announcement about this before year-end.

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