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Sarepta, BioMarin settle patent litigation over DMD exon-skipping drugs

PBR Staff Writer Published 19 July 2017

Sarepta Therapeutics and BioMarin Pharmaceutical have settled a global patent litigation relating to the use of the former’s Exondys 51 and all future exon-skipping products for the treatment of Duchenne muscular dystrophy (DMD).

The two companies have also entered into a license agreement which gives the global exclusive rights of BioMarin's DMD patent estate to Sarepta Therapeutics for $35m.

Sarepta will also make certain additional regulatory and commercial milestone payments for exons 51, 45, 53 and probably on other exon-skipping products to be developed in the future.

Additionally, BioMarin will receive certain royalties from Sarepta and will hold onto the right to convert the license to a co-exclusive right if it decides to move ahead with an exon-skipping therapy for DMD.

BioMarin executive vice president and general counsel G. Eric Davis said: "We are pleased to reach a global settlement and license agreement with Sarepta that fairly recognizes the important innovation by the Leiden University Medical Center and allows patients certainty that this issue will not create a barrier to access.”

The agreements between the two parties will be based on closing conditions including receipt of mandatory approvals from Academisch Ziekenhuis Leiden (AZL) by July 24.

As per Sarepta president and CEO Douglas Ingram, the global license and settlement agreements after becoming effective would give the company freedom all over the world to operate for Exondys 51 and any of its future exon-skipping products.

Ingram added: "The resolution of these legal matters provides us with more certainty to fully focus our resources and energy on our crucial mission of developing innovative medicines to improve the lives of those impacted by DMD around the world."