Research & Development
Alkermes reports USD150m milestone payment on FDA approval of VUMERITY
13 November 2019 -

Biopharmaceutical company Alkermes plc (Nasdaq:ALKS) on Tuesday announced a USD150m milestone payment from Biogen, following US Food and Drug Administration (FDA) approval of VUMERITY for the treatment of relapsing forms of multiple sclerosis and transfer of the New Drug Application and other regulatory documentation related to VUMERITY to Biogen Inc (Nasdaq:BIIB).

VUMERITY (diroximel fumarate) is a novel oral fumarate with a distinct chemical structure approved for treating relapsing forms of multiple sclerosis. In the body, VUMERITY rapidly converts to monomethyl fumarate, the same active metabolite of dimethyl fumarate, said the company.

In conjunction, the company's financial expectations for 2019 reflect this milestone payment. It will record substantially all of the milestone payment as license revenue in the fourth quarter of 2019.

As part of the license and collaboration agreement with Biogen, Alkermes was responsible for conducting the clinical development of VUMERITY and regulatory activities relating to its approval; Biogen holds the exclusive, worldwide license to commercialise the product.

Additionally, Alkermes is entitled to receive a mid-teens percentage royalty on worldwide net commercial sales of VUMERITY, subject to minimum annual payments for the first five years following FDA approval and customary reductions in the agreement.