$125-million priority review voucher drug sale sets benchmark

Pharmaceutical manufacturers got a better idea of the value of FDA’s Priority Review Vouchers (PRVs) recently after Gilead Sciences paid $125 million in cash for Knight Therapeutics’ Neglected Tropical Disease PRV.

FDA granted the PRV to Knight in March, with the approval ofmiltefosine (Impavido) for treatment of patients with visceral, mucosal and cutaneous leishmaniasis. Knight opted to sell the voucher, which helps other drug makers by giving them an idea of what the PRVs might be worth.

"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,” said Jonathan Ross Goodman, director of Knight. Leishmaniasis is considered a neglected tropical disease and is one of 16 tropical diseases that qualify for a PRV.

The FDA initiated its PRV program, which allows companies to transfer PRV approvals, in 2008 to encourage development of drugs to prevent and treat tropical diseases that affect millions of people globally. “There has been remarkably little progress over the last 50 years in development of drugs for these diseases. Because these diseases are found primarily in poor and developing countries, existing incentives have been insufficient to encourage new and innovative drug therapies,” FDA wrote in its Guidance for Industry.

Drug manufacturers can apply for applications for PRVS for tuberculosis, malaria, blinding trachoma, Buruli ulcer, cholera, dengue, leprosy, and other diseases, particularly infectious diseases for which there is no signficant market in developed countries and that disproportionately affects poor and marginalized populations, according to FDA.

[BLOG]: Providers and payers shared responsibility in making antibiotic stewardship programs a priority

Under Prescription Drug User Fee Act (PDUFA), FDA sets a target of 10 months from the date FDA accepts the application for a standard review of a New Drug Application (NDA) or a Biologic License Application (BLA). FDA reduces its target review time for an NDA or BLA to 6 months from the date FDA accepts the application, speeding up the initial review of the drug.

The latest FDA drug approvals