CSL has agreed to pay Momenta Pharmaceuticals $50 upfront as part of an exclusive research collaboration and global licence agreement to develop and commercialize Fc multimer proteins, including Momenta’s selective Fc receptor immunomodulator, M230, for the treatment of autoimmune disorders. The deal gives CSL an exclusive license to M230, which is anticipated to enter clinical development in 2017. Momenta could also receive another $550 million in clinical, regulatory, and commercialization milestones and retains an option to elect a profit-sharing arrangement, in the case of which it would partly fund global development and commercialization costs in return for a share of U.S. profits, plus ex-U.S. milestones and royalties. Cambridge, MA-based Momenta also has an option to a U.S. co-promotion agreement for M230 and any other product developed through the collaboration. CSL and Momenta expect to start a research collaboration that will focus on developing new Fc multimer proteins originating from either company’s research.
“This collaboration and license agreement with CSL validates our belief that M230 is an exciting recombinant product candidate for potential use in autoimmune indications,” said Craig A. Wheeler, president and CEO of Momenta Pharmaceuticals. “As the global leader in immunoglobulin (Ig) therapy, CSL is the ideal development and commercialization partner for us in the area of Fc biology given their expertise in developing plasma-derived medicines and focus on creating disruptive recombinant products in the autoimmune space.”
Momenta is developing generic versions of complex drugs, biosimilars, and novel therapeutics for autoimmune disorders. At the end of November 2016, the firm reported positive topline data from a confirmatory Phase III study evaluating M923, a biosimilar of Humira® (adalimumab). The drug had been in development in partnership with Shire, but Shire ended its biosimilars collaboration with Momenta in September 2016 as a result of a portfolio reassessment following the merger of Shire with Baxalta in June. Earlier in November, Momenta initiated a Phase I study evaluating its Orencia® (abatacept) biosimilar candidate, M834, which is being developed in collaboration with Mylan, under the firms’ agreement for six Momenta biosimilars.