29 November 2017 - - Cambridge, Massachusetts-based neurological and autoimmune disease therapies specialist Biogen (NASDAQ: BIIB) and Dublin, Ireland-based global biopharmaceutical company Alkermes plc (NASDAQ: ALKS) have entered into a global license and collaboration agreement to develop and commercialize ALKS 8700, a novel, oral, monomethyl fumarate small drug molecule for the treatment of relapsing forms of multiple sclerosis (MS), the companies said.
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 50% of the 2017 ALKS 8700 development costs, with Alkermes receiving an upfront payment of USD 28m representing Biogen's share of development expenses already incurred in 2017.
Beginning Jan. 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 USD200 m upon certain clinical and regulatory achievements.
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 the treatment of MS. Biogen shall be responsible for all commercialization activities for ALKS 8700.
ALKS 8700 is designed to rapidly and efficiently convert to monomethyl fumarate in the body and to offer differentiated features as compared to the currently marketed dimethyl fumarate, Tecfidera.
Alkermes is developing innovative medicines for the treatment of central nervous system diseases.
The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis.
Headquartered in Dublin, Ireland, the company has an R and D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
Biogen discovers, develops, and delivers therapies for people living with serious neurological and neurodegenerative diseases.
The company has a leading portfolio of medicines to treat multiple sclerosis and spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer's disease, Parkinson's disease and amyotrophic lateral sclerosis (ALS).
Biogen also manufactures and commercializes biosimilars of advanced biologics.