Biotech Values

[DewDiligence]

MNTA/BXLT Humira FoB shows bioequivalence to Humira in phase-1 study:

http://finance.yahoo.com/news/baxalta-momenta-announce-m923-proposed-114500431.html

Baxalta Incorporated (NYSE:BXLT) and Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), today announced that M923 met the primary endpoint in a randomized, double-blind, three-arm, parallel group, single-dose study. The primary objective of the study was to evaluate the pharmacokinetics of M923 compared to both U.S. and EU sourced HUMIRA reference products.

In addition to showing bioequivalence in pharmacokinetics, this study also evaluated safety, tolerability and immunogenicity following single doses of M923 given by injection. The safety profile and immunogenicity were also found to be comparable. A total of 324 healthy volunteers were enrolled in the study.

…Baxalta and Momenta announced the initiation of a separate pivotal clinical trial of M923 in chronic plaque psoriasis in October 2015 [#msg-117482545]. The companies are targeting a first regulatory submission in 2017 and a first commercial launch as early as 2018.

In the US market, the timing of the product launch depends on whether ABBV can enforce its US non-CoM Humira patents—see discussion in #msg-118781959.