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Regulatory News | 29 November 2017 | By Zachary Brennan
In the early days of the priority review voucher (PRV) programs, back in 2014 and 2015, companies publicly disclosed who they sold their PRVs to, how much they cost and which products they were eventually used to speed the review of.
But now that 17 PRVs have been issued by the US Food and Drug Administration (FDA), news of PRV sales has slowed to a trickle of SEC filings and the rare press release.
Three times already in 2017, with GlaxoSmithKline and Teva’s purchases of PRVs and Biomarin’s sale of a PRV for $125 million this week, information was lacking on either the purchaser or who the PRV was purchased from, meaning that the undisclosed companies are either private or large enough, like Novartis, that such a disclosure is not necessary. David Ridley, a business professor at Duke University, who co-authored a paper in Health Affairs in 2006 that first proposed the PRV system, told Focus: "One advantage of doing business with a privately-held company is that they don't have to report much about the voucher sale. If the buyer is a big pharma company then they don't have to report much either. It's only small, publicly-traded companies that need to report, because it's only material for them. So a large pharma buyer might prefer to do business with a small, privately-held company -- and perhaps pay a premium over what they'd pay to a small, publicly-held company."
To understand how many and which PRVs are still available for purchase with only publicly available information has turned into a guessing game. Eight of 17 PRVs have no information disclosed on what has happened to them, though two of those eight were presumably purchased by GSK and Teva, and others, like the one transferred from Wellstat Therapeutics to AstraZeneca in 2015, may still be re-sold.
But Ridley notes that, "Fortunately we have (most of) the important information: (1) the awarded vouchers and (2) the selling price of (most) vouchers."
The prices of the last four PRVs sold also reveal a decline in PRV value that researchers had expected with more coming to market. In 2017, PRVs have sold in the range of $125 million to $150 million, a far cry from the $350 million AbbVie paid in 2015.
Another shift has been the increasing number of rare pediatric disease PRVs issued. Eight of the last 10 PRVs issued has gone for a company winning approval of a rare pediatric disease drug, which compares to three of the first four PRVs going for tropical disease drug approvals.
And with the establishment of a new PRV program for material threat medical countermeasures thanks to the 21st Century Cures Act, the number of PRVs available for purchase will likely increase, possibly further bringing down the price that PRVs fetch on the open market.
FDA says it intends to implement the Cures law and new PRV program "consistently with implementation of the other PRV programs," noting that some of the diseases listed under FDA’s Tropical Disease PRV program are also identified as material threats, though "the statute does not permit the same application to receive a voucher under more than one program."
Tags: priority review vouchers, transparency, PRV prices