Deals, Legal

BioMarin may have lost the battle in DMD rivalry, but it won a $35M argument with Sarepta

BioMarin $BMRN may have lost big on their expensive and high-profile bid to get an OK for a troubled Duchenne muscular dystrophy drug, but the West Coast biotech is getting a consolation prize from Sarepta — the big winner so far in the US with its marketed drug Exondys 51.

Doug Ingram

Sarepta $SRPT is paying BioMarin $35 million to settle their scrap over rights to exon-skipping tech, reserving some 5% and 8% royalty streams for certain exon-skipping therapies. And new Sarepta CEO Doug Ingram lauded the fact that the biotech now has “worldwide freedom” to operate on a drug that it wholly controls.

A filing with the SEC, though, provides some details on this settlement that aren’t in the release. Sarepta states:

Under the terms of the License Agreement, the Company is required to pay BioMarin an upfront payment of $15 million, and BioMarin will be eligible to receive up to $20 million from the Company per dystrophin gene exon (other than exon 51) targeted by one or more Products in specified regulatory milestones, as well as an additional $10 million milestone, payable following the regulatory approval of eteplirsen by the European Medicines Agency. BioMarin will also be eligible to receive $15 million from the Company upon the achievement of $650 million in sales, as well as royalties segmented by specified geographic markets, in some of jurisdictions dependent on an the existence of a patent, ranging from four (4) to eight (8) digit percentages of net sales on a product-by-product and country-by-country basis.

BioMarin gambled $680 million in cash when it decided to buy Prosensa and its failed DMD drug drisapersen and make a bid to revive its prospects at the FDA. That effort was hit head on by the FDA’s rejection in early 2016. If BioMarin chooses to go for another exon-skipping drug, the company has rights to opt in on a co-exclusive deal with Sarepta.

“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,” said BioMarin general counsel G Eric Davis.

 


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