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The recent approval by FDA of Vumerity (diroximel fumarate), a new drug for treating multiple sclerosis, has a triggered a $150-million milestone payment from Biogen to Alkermes.
On Nov. 12, 2019, Alkermes announced the receipt of a $150-million milestone payment from Biogen triggered by the recent FDA approval of Vumerity (diroximel fumarate), a novel oral fumarate with a distinct chemical structure for treating relapsing forms of multiple sclerosis. Alkermes had transferred the new drug application and other regulatory documentation related to Vumerity to Biogen. FDA approved the drug in October 2019.
"The receipt of this milestone payment marks an important achievement for Alkermes and is a testament to the strategic execution of our clinical and regulatory activities related to [Vumerity] over the past few years. This payment bolsters our solid financial foundation and increases our flexibility to pursue strategic business development opportunities and invest in our internal development pipeline," commented Blair Jackson, senior vice-president of Corporate Planning, Alkermes, in a company press release.
Under 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 commercialize the product. Alkermes is entitled to receive a mid-teens percentage royalty on worldwide net commercial sales, subject, under certain circumstances, to minimum annual payments for the first five years following FDA approval and customary reductions as set forth in the agreement.