Retrophin, Inc. has sold its priority review voucher to Sanofi for $245 million in cash.
In March, Retrophin bought small drugmaker, Asklepion Pharmaceuticals, for roughly $75 million, gaining Cholbam (cholic acid), a drug approved by the US Food and Drug Administration (FDA). Retrophin has already gained that $75 million back with Sanofi purchasing the Rare Pediatric Disease Priority Review Voucher (Pediatric PRV), which the company gained from gaining Cholbam.
The Pediatric PRV program is intended to encourage development of new drug and biological products for prevention and treatment of certain rare pediatric diseases. The owner of the voucher can use it to receive priority review of a single New Drug Application (NDA) or Biologics License Application (BLA), reducing the target review time potentially leading to an expedited approval. The priority review cuts the review period from the standard 10-month timeline to a 6-month timeline.
Under the deal, Sanofi will pay Retrophin $150 million, followed by two equal installments of $47.5 million in 2016 and 2017. Retrophin will receive a total consideration of $245 million in cash in exchange for the FDA-awarded voucher.
“We are pleased to know that transferring our voucher will raise awareness of the Pediatric PRV program and give us added flexibility to find and develop new therapies for patients with severe rare diseases,” said Stephen Aselage, Chief Executive Officer of Retrophin.
Sanofi has not disclosed what it plans to use the voucher for.
The FDA vouchers have been beneficial assets to hold, with holders having the ability to sell the voucher to the highest bidder. Previously, Gilead Sciences paid $125 million for a voucher. Additionally, last year Sanofi and Regeneron spent $67.5 million on a voucher which it used on its cholesterol drugs.
Source: Retrophin, Inc.
Last updated: 5/27/15; 11:20am EST