Sarepta & BioMarin Settle Patent Litigation on Exon Skipping

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Sarepta Therapeutics, Inc. SRPT and BioMarin Pharmaceutical Inc. BMRN , have settled their ongoing global patent litigation regarding the exclusive license on a patent pertaining to exon skipping technology used in Duchenne muscular dystrophy (DMD) therapies. BioMarin has licensed the global exclusive rights to its DMD patent estate for Exondys 51 and all future exon-skipping products to Sarepta Therapeutics.

Exondys 51 is a key drug for Sarepta and is marketed for the treatment of DMD in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.

A look at the company’s share price movement shows that, Sarepta has outperformed the Zacks categorized Medical-Biomed/Genetics industry so far this year. While the stock has rallied 23.5%, the broader industry witnessed a gain of 8.8%.

Per the agreement, Sarepta will make a one-time payment of $35 million to Biomarin plus unspecified regulatory and commercial milestone payments for exons 51, 45, 53, and on future exon-skipping products. Additionally, the company will pay BioMarin royalties for compounds skipping exons 51, 45, and 53, and possibly on future exon-skipping products.

BioMarin is entitled to receive 5% royalty on U.S. sales (through 2023) of Exondys 51 and both exons 45 and 53 skipping compounds, which use the exon skipping technology, and 8% royalty on European sales of the products (through Sep 2024).

BioMarin, however, has held back the right to convert the license to a co-exclusive right in case it decides to proceed with an exon-skipping therapy for DMD.

If Sarepta had not made the settlement with BioMarin, the latter could preclude Sarepta from commercializing Exondys 51 in several jurisdictions. Thus the settlement of patent litigation and the global license from Biomarin removes a major overhang for Sarepta.

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