Biogen and Alkermes have signed a license and collaboration agreement to develop and commercialize ALKS 8700, an oral, monomethyl fumarate small-drug molecule in Phase III development for treating relapsing forms of multiple sclerosis (MS).

Under 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 50% 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 US Food and Drug Administration through the potential approval of the new drug application for ALKS 8700 for treating MS. Biogen will be responsible for all commercialization activities for ALKS 8700.

ALKS 8700 is currently in Phase III development for treating MS. Alkermes plans to seek approval of ALKS 8700 under the 505(b)(2) regulatory pathway referencing Biogen’s Tecfidera (dimethyl fumarate). A 505 (b)(2) NDA is a pathway created by the Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to a section of the Federal Food, Drug, and Cosmetic Act. It applies to various uses, including changes in dosage form, strength, route of administration, formulation, dosing regimen, or indication.

Source: Biogen