Biogen and Alkermes announce collaboration for MS treatment ALKS 8700

Biogen and Alkermes have announced a global license and collaboration agreement to develop and commercialise ALKS 8700, a novel, oral, monomethyl fumarate (MMF) small drug molecule for the treatment of relapsing forms of multiple sclerosis (MS).

"This partnership is further evidence of Biogen’s ongoing commitment to multiple sclerosis and builds upon our deep experience in neuroscience and particularly in MS," stated Michel Vounatsos, Chief Executive Officer at Biogen. "We aim to provide patients with a new oral therapy which may bring differentiated benefits."

"This collaboration has the potential to provide important benefits to patients with multiple sclerosis and immediately increases the value of ALKS 8700 to Alkermes," said Richard Pops, Chief Executive Officer at Alkermes. "Biogen has a broad product portfolio and a highly experienced commercial team. In Biogen’s hands, we believe that patients will have broader and more rapid access to this important medicine. Meanwhile, we will focus our growing commercial capabilities on our expanding portfolio of medicines in psychiatry, including addiction, schizophrenia and depression."

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

This collaboration aligns the interests of Alkermes and Biogen in the successful development and commercialisation of ALKS 8700 as an important potential treatment option for patients suffering from MS. Biogen will reimburse Alkermes for 50% of the 2017 ALKS 8700 development costs, with Alkermes receiving an upfront payment of US$28mn, representing Biogen’s share of development expenses already incurred in 2017. Beginning 1 Jan 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 US$200mn upon certain clinical and regulatory achievements. Biogen anticipates the initial milestone payment of US$50mn will be recorded as an expense in 2017.

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