Spark Therapeutics agreed to sell its priority review voucher, good for four months off an FDA decision date for any product, to Jazz Pharmaceuticals for $110 million—providing Spark a nice bonus on top of its recent approval for the world’s most expensive drug.
Despite the size of the investment, a Jazz spokesperson said the company has not yet decided on its plans for the voucher, but that it could speed review of one of its own candidates or a future asset from its corporate development efforts.
Spark plans to reinvest the capital into its R&D programs, Joseph La Barge, the company’s chief legal officer, said in a statement. The FDA called Luxturna the first gene therapy approved to target a disease based on a specific mutation.
Jazz’s offer comes in below the average prices seen for vouchers over the past two years, which have ranged between $125 million and $200 million. The secondary market for these transferable vouchers—granted after approvals for rare pediatric and certain tropical diseases, as well as for medical countermeasures against biological weapons—peaked in 2015, with AbbVie’s $350 million purchase from United Therapeutics, originally granted for Unituxin (dinutuximab) in pediatric neuroblastoma.
Currently, Jazz is recruiting patients in a phase 3 clinical trial of JZP-258, a narcolepsy treatment, and hopes to complete the study by the end of the year. A second phase 3 trial, evaluating defibrotide for preventing hepatic veno-occlusive disease after hematopoietic stem cell transplants, is expected to be completed by early 2021.
Theoretically, the voucher could be used to speed up the FDA’s review of either product, or any drug in its pipeline, to just six months instead of the standard 10. The company is scheduled to report its first-quarter financial results and provide a business update May 8, after the financial markets close. The sale is subject to customary closing conditions.
In another recent financial gain for Spark and Luxturna, the company signed a a $170 million agreement with Novartis to license and commercialize the drug outside the U.S. in January, with a European approval expected in the third quarter of this year. Novartis will be responsible for obtaining regulatory clearance outside the U.S. and the European Union, while Spark will manufacture and supply the treatment.