BioCentury
ARTICLE | Company News

Momenta, Mylan deal

January 18, 2016 8:00 AM UTC

Momenta granted Mylan exclusive, worldwide rights to co-develop and commercialize six preclinical biosimilar candidates, including M834, a biosimilar of rheumatoid arthritis (RA) drug Orencia abatacept from Bristol-Myers Squibb Co. (NYSE:BMY, New York, N.Y.). M834 is a CLA-4 ( CD152)-Ig fusion protein that is expected to enter the clinic in mid-2016.

Momenta will conduct non-clinical development and initial clinical development for all product candidates and pivotal or Phase III development for M834. Momenta also will conduct U.S. regulatory activities for all products through approval. Mylan will conduct pivotal or Phase III development for candidates other than M834, regulatory activities for all candidates outside the U.S. and regulatory activities for all products in the U.S. following regulatory approval. Mylan will commercialize any approved products. ...