Biogen In Deal With Alkermes To Develop, Commercialize ALKS 8700 For MS

(RTTNews) - Biogen Inc. (BIIB) announced Monday that it has entered into a global license and collaboration agreement with Alkermes plc (ALKS) to develop and commercialize ALKS 8700 for the treatment of Multiple Sclerosis or MS. New Drug Application or NDA for ALKS 8700 is anticipated for submission in 2018.

Under the terms of the agreement, Biogen will receive an exclusive, worldwide license to commercialize ALKS 8700 and will pay Alkermes a mid-teens royalty on worldwide net sales of ALKS 8700.

Biogen will reimburse Alkermes for fifty percent of the 2017 ALKS 8700 development costs, with Alkermes receiving an upfront payment of $28 million representing Biogen's share of development expenses already incurred in 2017.

Beginning January 1, 2018, Biogen will be responsible for all development expenses related to ALKS 8700. Alkermes may also receive milestone payments for ALKS 8700 with a maximum aggregate value of $200 million upon certain clinical and regulatory achievements. Biogen anticipates the initial milestone payment of $50 million will be recorded as an expense in 2017.

Alkermes will maintain responsibility for regulatory interactions with the U.S. Food and Drug Administration through the potential approval of the NDA for ALKS 8700 for the treatment of MS. Biogen shall be responsible for all commercialization activities for ALKS 8700.

ALKS 8700 is a novel, oral, monomethyl fumarate or MMF small drug molecule in Phase 3 development for the treatment of relapsing forms of MS.

ALKS 8700 is currently in Phase 3 development for MS. Alkermes plans to seek approval of ALKS 8700 under the 505(b)(2) regulatory pathway referencing Biogen's TECFIDERA (dimethyl fumarate).

Also, currently underway is a head-to-head study (EVOLVE-MS-2) evaluating the GI tolerability of ALKS 8700 compared to TECFIDERA. Initial data from EVOLVE-MS-2 are expected in the first half of 2018.