Priority Review Voucher Prices Soar Amid Supply Concerns and New FDA Program

Bavarian Nordic's recent sale of a Priority Review Voucher (PRV) for $160 million has highlighted a significant upward trend in PRV values, driven by concerns over declining supplies and changes in FDA programs. This development comes alongside advancements in chikungunya vaccine approvals and a new FDA initiative aimed at expediting drug reviews.

PRV Market Dynamics and Program Changes

The value of PRVs, which can reduce FDA review times from 10 months to six months, has seen a marked increase in recent months. Bavarian Nordic's sale, stemming from the approval of its chikungunya vaccine Vimkunya, represents a substantial jump from earlier transactions. In February 2024, Valneva sold a PRV for $103 million, while more recent sales by companies such as Ipsen, PTC Therapeutics, Acadia Pharmaceuticals, and Zevra Therapeutics have ranged from $150 million to $158 million.

This price surge coincides with the sunset of the FDA's rare pediatric disease PRV program in December 2024, which has historically accounted for about 70% of all PRVs awarded since 2009. The program's lapse has raised concerns about future PRV availability, potentially driving up values for remaining vouchers, particularly those awarded under the tropical disease program.

In response to these market changes, the FDA has introduced a new initiative called the "Commissioner's National Priority Voucher" (CNPV). This program aims to further expedite drug reviews to as little as one or two months for companies aligned with U.S. national priorities. Unlike traditional PRVs, CNPVs are non-transferrable, potentially impacting their market value.

Chikungunya Vaccine Developments

The PRV sale by Bavarian Nordic is tied to the approval of Vimkunya, its chikungunya vaccine. This approval follows that of Valneva's Ixchiq, the first chikungunya vaccine approved in the U.S. However, recent developments have differentiated the two products in the market.

In May, the FDA and CDC recommended pausing the use of Valneva's Ixchiq in individuals 60 years and older due to postmarketing reports of serious adverse events, including two deaths. Conversely, Bavarian's Vimkunya received a recommendation from the CDC's Advisory Committee on Immunization Practices for use in individuals aged 12 and older traveling to areas with chikungunya outbreaks.

Vimkunya's approval covers a broader age range, starting from 12 years old, while Ixchiq is only approved for adults. Additionally, Vimkunya utilizes a virus-like particle construct, differing from Ixchiq's live-attenuated vaccine approach.

These developments underscore the evolving landscape of both the PRV market and vaccine approvals in the pharmaceutical industry, with significant implications for drug development incentives and public health strategies.