Biotech Values

[DewDiligence]

MNTA +10%/PM on phase-3 results for Humira FoB (M923):

http://finance.yahoo.com/news/momenta-pharmaceuticals-announces-positive-top-130000125.html

Momenta Pharmaceuticals, Inc. (MNTA) today announced that the confirmatory Phase 3 clinical study of M923, a biosimilar HUMIRA…in patients with moderate-to-severe chronic plaque psoriasis, met its primary endpoint. The proportion of subjects in the study who achieved the primary endpoint, at least 75% reduction in the Psoriasis Area and Severity Index (PASI-75) following 16 weeks of treatment, was equivalent between M923 and HUMIRA. The estimated difference in responders was well within the pre-specified confidence interval, confirming equivalence.

Equivalence was also achieved in all secondary efficacy endpoints, including the achievement of PASI-50, PASI-90, proportion achieving clear or near-clear skin, and change from baseline in absolute PASI score. Adverse events were comparable in terms of type, frequency, and severity, and were consistent with the published safety data for HUMIRA.

M923 is now wholly owned by MNTA, although SHPG is still funding development subject to the contractual agreement between the companies (#msg-125412687).