The price of purchasing a priority review voucher just went up.
Earlier this year, Regeneron purchased
a Rare Disease Pediatric Disease Priority Review Voucher from Biomarin Pharmaceuticals for $67.5 Million. Now, Gilead plans to purchase a priority review voucher from Canadian company Knight Therapeutics for $125 Million.
Knight Therapeutics received a Neglected Tropical Disease Priority Review Voucher in March 2014 when its orphan drug Impavido (miltefosine) was approved for the treatment of patients with visceral, mucosal and cutaneous leishmaniasis.
In a press release
, Jonathan Ross Goodman, Director of Knight Therapeutics said:
"We are thrilled to successfully transfer our priority review voucher in expectation that this will encourage others to invest in R&D for neglected tropical diseases for the benefit of humanity.”
The standard review time of a New Drug Application (“NDA”) or a Biologic License Application (“BLA”) is 10 months. A priority review, time is only 6 months but it is only given if it is for a drug that treats a serious condition and would provide a significant improvement in safety or effectiveness.
The Priority Review Voucher program was introduced to encourage companies to develop drugs for rare pediatric conditions or neglected tropical diseases. If the company’s drug gets approved, the FDA can give them a voucher that they can then use for future drug applications. And the vouchers can be applied to ANY future drug application by the company. The Priority Review Voucher is also transferable and that is why Regeneron bought one from Biomarin and that is why Gilead plans to buy one from Knight Therapeutics. By buying the voucher, Gilead can use it for any drug undergoing FDA review. In other words, they can potentially get a drug to market 4 months earlier. And Gilead thinks that is worth $125 Million.