Big Molecule Watch
September 27, 2016

Dealwatch: Shire Returns Etanercept Rights to Coherus and Adalimumab Rights to Momenta

Shire plc has returned development rights to two biosimilar candidates to Coherus BioSciences, Inc. and Momenta Pharmaceuticals, Inc., reportedly based on a strategic portfolio review following Shire’s June 2016 acquisition of Baxalta Incorporated.

Coherus announced that it has “regained from Shire plc all development and commercial rights previously licensed for CHS-0214 etanercept, a biosimilar candidate to Enbrel®, for Europe, Canada, Brazil, the Middle East and other territories.”  This adds to Coherus’s prior existing U.S. rights for CHS-0214.  The transaction “includes no present or future payments from Coherus.”  Coherus expects to submit a Marketing Authorization Application to the European Medicines Agency in the fourth quarter of 2016.

Momenta announced that Shire terminated its collaboration agreement with Momenta to develop and commercialize M923, a proposed biosimilar of HUMIRA (adalimumab).  Momenta stated that “[u]nder the terms of the 2011 collaboration agreement, the agreement will terminate twelve months following the notice and Shire will continue to be obligated to fund the M923 program until termination. Shire will begin to work to transfer all ongoing clinical, regulatory and commercialization activities to Momenta.”  Momenta stated that “M923 is currently in a Phase 3 pivotal trial in patients with chronic plaque psoriasis to compare the safety, efficacy and immunogenicity of M923 with HUMIRA.”