Sarepta Sells Priority Review Voucher for $125M to Gilead

Posted 21 February 2017 By Zachary Brennan

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Sarpeta Therapeutics on Tuesday sold its priority review voucher (PRV) to Gilead for $125 million, speeding up the US Food and Drug Administration (FDA) approval process for any future drug or biologic of Gilead’s choosing from 10 months to six months.

The voucher was awarded to Sarepta under the rare pediatric PRV program after winning FDA approval for its Duchenne Muscular Dystrophy (DMD) drug Exondys 51 (eteplirsen) in September 2016.

This is the third PRV Gilead has purchased after buying PaxVax’s PRV last summer for about $200 million and Knight Therapeutics’ PRV in 2014 for $125 million, which Gilead used to gain approval for its HIV drug Odefsey.

The $125M price tag for Sarepta’s PRV puts it in the middle of the pack for sales of the lucrative vouchers. The most expensive PRV was sold by United Therapeutics to AbbVie for $350 million in August 2015, while the cheapest was sold by BioMarin to Sanofi and Regeneron for $67 million in 2014.

With Sarepta’s PRV now off the market, the remaining PRVs for sale include: two from Alexion Pharmaceuticals, awarded for winning FDA approval of Strensiq (asfotase alfa) as the first treatment for perinatal, infantile and juvenile-onset hypophosphatasia and Kanuma (sebelipase alfa), the first treatment for patients with a rare disease known as lysosomal acid lipase deficiency (though Alexion has said it would like to keep one), one from Biogen and Ionis for winning approval of the first spinal muscular atrophy treatment Sprinraza (nusinersen), one from Janssen for winning approval back in 2012 of the tuberculosis treatment Sirturo (bedaquiline) and the most recently awarded one to Marathon Pharmaceuticals for its DMD drug Emflaza (deflazacort).

The number of PRVs on the market is also likely to increase even more as the recently passed 21st Century Cures law reauthorized the rare pediatric PRV program until October 2020, and creates a new PRV program for medical countermeasures that will sunset on 1 October 2023. Several bills have also been floated to add a PRV program to further incentivize the development of generic drugs. The influx of PRVs comes as FDA has said it does not support the programs as the agency is forced to speed the review of a drug or biologic that might not align with public health priorities.

For more on PRVs, read the FocusPRV explainer.

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Categories: Biologics and biotechnology, Drugs, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA

Tags: Sarepta, Gilead, priority review voucher, PRV, Cures

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