Date: 2015-08-19
Type of information: Commercialisation agreement
Compound: Rare Pediatric Disease Priority Review Voucher (PPRV)
Company: Abbvie (USA - IL) United Therapeutics (USA - MD)
Therapeutic area: Rare diseases
Type agreement: commercialisation
Action mechanism:
- The Rare Pediatric Disease Priority Review Voucher Program (PPRV) is a FDA program intended to encourage development of new drug and biological products for prevention and treatment of certain rare pediatric diseases. Under this program, a sponsor who receives an approval for a drug or biologic for a "rare pediatric disease" may qualify for a PRV that can be redeemed to receive a priority review of a subsequent marketing application for a different product. The sponsor receives the PRV upon approval of the rare pediatric disease product application and it can be sold or transferred.
Disease:
Details:
- • On August 19, 2015, United Therapeutics Corporation announced that it has entered into an agreement to sell its Rare Pediatric Disease Priority Review Voucher (PPRV) to a subsidiary of AbbVie . United Therapeutics received the PPRV when Unituxin™ was approved by the FDA for the treatment of neuroblastoma, a rare pediatric disease. The Rare Pediatric Disease Priority Review Voucher Program is intended to encourage development of new drug and biological products for prevention and treatment of certain rare pediatric diseases. A PPRV may be issued to the sponsor of a rare pediatric disease product application and would entitle the holder to priority review of a single New Drug Application or Biologics License Application, which reduces the target review time and could lead to an expedited approval. The sponsor receives the PPRV upon approval of the rare pediatric disease product application and it can be sold without limitation.
- The transaction is subject to customary closing conditions and clearance under the Hart-Scott-Rodino Antitrust Improvements Act.
Financial terms:
- Upon closing of the transaction, United Therapeutics will receive $350 million in cash in exchange for the PPRV. The voucher was awarded by the FDA under a provision that encourages development of new drugs and biologics for the prevention and treatment of rare pediatric diseases.
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