Retrophin Sells FDA Voucher to Sanofi for $245 Million -- Update

By Chelsey Dulaney 

Retrophin Inc. on Wednesday said it agreed to sell a special voucher meant to speed drug approval to French drug maker Sanofi SA for $245 million in cash.

Shares of Retrophin, up 87% in the past year, added 7% to $28.70 in premarket trading.

Retrophin obtained the rare-pediatric-disease priority-review voucher as part of a deal earlier this year to buy Cholbam from Asklepion Pharmaceuticals LLC after the drug was approved by the U.S. Food and Drug Administration for treatment of a pair of genetic metabolic disorders.

Sanofi will make an initial payment of $150 million, followed by two payments of $47.5 million each in 2016 and 2017.

The voucher is part of an incentive program established by the FDA to encourage development of drugs for rare pediatric diseases. The voucher entitles the holder to ask the FDA for priority review of a drug application that would otherwise get a standard review. That could shorten the review process to six months from the standard 10 months.

Last July, Sanofi and Regeneron Pharmaceuticals Inc. agreed to pay $67.5 million to buy BioMarin Pharmaceuticals Inc.'s pediatric voucher, a move to help them speed their experimental cholesterol drug to the market.

Write to Chelsey Dulaney at [e-mail]

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