Shire (SHPG) Terminates HUMIRA Biosimilar Collaboration Agreement with Momenta Phama (MNTA)

September 27, 2016 8:01 AM EDT
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Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA) announced that Shire has exercised its right to terminate its collaboration agreement with the Company to develop and commercialize M923, a proposed biosimilar of HUMIRA (adalimumab), based on a comprehensive portfolio assessment following the acquisition of Baxalta. Under 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.

“Baxalta has been a strong collaborative partner and we thank them for their efforts in advancing this important program through late-stage clinical development,” said Craig Wheeler, President and CEO of Momenta. “We view Shire’s decision as a significant opportunity for us to capture additional value from this program for the Company and its shareholders. We remain very excited about the potential for our biosimilar HUMIRA candidate and look forward to reporting top-line results of the current Phase 3 trial of M923 in late 2016.”

About M923, a proposed biosimilar of HUMIRA® (adalimumab)HUMIRA, the largest selling therapeutic on the market today, is a significant intervention for patients with autoimmune/inflammatory diseases. Adalimumab is used to treat many such conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis and plaque psoriasis. 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.

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