Momenta Pharmaceuticals Announces Acceptance Of A Clinical Trial Application In Europe for M923, A Biosimilar Version Of Humira

Momenta Pharmaceuticals, Inc.

, a biotechnology company specializing in the characterization and engineering of complex drugs, today announced the acceptance by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of a Clinical Trial Application (CTA) to initiate a clinical trial for M923, a biosimilar version of Humira® (adalimumab), in its collaboration with Baxter International's biopharmaceutical business. Acceptance of the CTA triggers two milestones under the Baxter collaboration with an aggregate payment of $12 million. Momenta expects to receive the payment in December 2014. "The European CTA acceptance for M923, our biosimilar version of Humira, represents a significant achievement by Momenta and Baxter in using the biosimilar regulatory pathway in an effort to expand patient choice," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "We look forward to the initiation of the clinical study in first quarter of 2015." Momenta is using its innovative technology to create a strong pipeline of biosimilars and potentially interchangeable biologics – a completely new segment of the biologics market. Momenta and Baxter have an ongoing collaboration for the worldwide development and commercialization of several biosimilar candidates at various stages of development, including M923 and M834.