- Priority review vouchers are commanding lower and lower prices in recent sales among drugmakers, suggested the once-coveted regulatory "fast pass" may be less attractive as more are issued by the Food and Drug Administration.
- In the latest example, Ultragenyx and Japanese pharma Kyowa Hakko Kirin sold a PRV which they had won in April to an undisclosed buyer for $80.6 million — a far cry from the $350 million AbbVie paid United Therapeutics for one back in 2015. BioCentury first reported the sale Tuesday.
- PRVs are awarded to companies that successfully secure approval of an eligible tropical disease, rare pediatric disease or a medical countermeasure. The vouchers can be redeemed to shorten review times for another experimental drug to six months from 10 months, or can be sold to another company.
It may be as simple as supply and demand. When AbbVie paid a premium for United Therapeutics' PRV, only half a dozen vouchers had been granted by the Food and Drug Administration.
Three years later, Ultragenyx and Kyowa Kirin sold their PRV in a market that's seen 23 vouchers awarded, 10 of which remain unused, according to Regulatory Focus.
Buyers do remain interested, it seems, with two prior sales in 2018 and five in 2017. But prices for the vouchers keep dropping. All five transactions disclosed in 2017 checked in between $125 million and $150 million.
In April, Spark Therapeutics sold off its PRV to Jazz Pharmaceuticals for $110 million and, now, Ultragenyx and Kyowa Kirin's deal adds an even lower price point. The $80.6 million figure is actually only $14 million higher than the first PRV sold by BioMarin to Sanofi and Regeneron in 2014.
PRV's don't expire, so companies may be seeking to stockpile the vouchers for future competitive launches, perhaps lowering their immediate value.
More PRVs are likely coming, too. The FDA recently established a new Material Threat Medical Countermeasure program and last month awarded the first voucher under that program to Siga Technologies for its smallpox treatment.
A recent study by Andrew Robertson, head of regulatory science and policy in Sanofi's North American business unit, predicted that the more PRVs are issued each year, the more prices dip — a finding that tracks with a 2016 Health Affairs study.
Six were awarded last year, which Roberston estimates translates to a minimum value of $77 million. Halfway through 2018, five have already been doled out by the FDA.