Momenta, Mylan Say M834 Fails To Meet Primary PK Endpoints In Phase 1 Study

(RTTNews) - Momenta Pharmaceuticals, Inc. (MNTA) and Mylan N.V. (MYL) announced that M834, a proposed biosimilar of ORENCIA or abatacept, did not meet its primary pharmacokinetic or PK endpoints in the Phase 1 study to compare the pharmacokinetics, safety and immunogenicity of M834 to US- and EU-sourced ORENCIA in normal healthy volunteers. Momenta and Mylan continue to gather and analyze these data to inform next steps for the program.

"This was an unexpected result and we are disappointed with the outcome of this PK study," said Craig Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals.

The Phase 1 study was a randomized, double-blind, three-arm, parallel group, single-dose subcutaneous administration clinical study to compare the pharmacokinetics, safety, and immunogenicity of M834, US-sourced ORENCIA, and EU-sourced ORENCIA in 243 normal healthy volunteers.

M834 is part of the collaboration between Mylan N.V. and Momenta Pharmaceuticals. ORENCIA is a fusion protein and the only CTLA-4Ig approved in the US, EU, and Japan for the treatment of Rheumatoid Arthritis and in the US and EU for the treatment of Psoriatic Arthritis and Juvenile Idiopathic Arthritis. In 2016, worldwide sales of ORENCIA totaled $2.4 billion.