Several priority-review vouchers have yet to change hands.
Indication: Lysosomal acid lipase deficiency
Indication: Spinal muscular atrophy
Recipient: Johnson & Johnson
Indication: Multi-drug-resistant tuberculosis
Indication: Duchenne muscular dystrophy
Note: Alexion plans to keep one of its two vouchers.
Gilead Sciences has paid Sarepta Therapeutics $125 million for a voucher that can speed up U.S. regulatory review of a new drug application. The price tag, modest compared to past sales, has some observers wondering whether the program is losing its luster.
Priority review vouchers were introduced in 2007 with the goal of spurring innovation in neglected tropical diseases. Expanded in 2012 to include rare childhood diseases, the program gives the developer of a drug with limited commercial potential a transferrable coupon that shaves four months off a future FDA drug review.
Until the sale of Sarepta’s PRV, the price of the vouchers had generally been on the rise. For example, Sanofi bought the first available PRV in 2014 for $67 million and later bought another one for $245 million. In 2015 AbbVie paid $350 million for its own fast-forward card.
Gilead itself has bought three PRVs, one of which it used to accelerate the approval of the HIV pill Odefsey. The company has not said how it plans to use the PRV from Sarepta, which earned it alongside approval of the Duchenne muscular dystrophy treatment Exondys 51.
A cooling in the price of PRVs is perhaps not surprising. After the rare pediatric disease PRVs were added, the number of vouchers on the market ballooned. Of the 13 PRVs handed out to date, nine are for rare drugs. Moreover, the recent passage of the 21st Century Cures Act extended the length of that pediatric program, despite protests from FDA officials who claim it has not worked as planned. The bill also added PRVs for “medical countermeasures”—treatments for biological or chemical threats.
Still, some are worried that PRVs may be losing their shine. “The price tag was even lower than our expectations of $200 million,” Leerink stock analyst Joseph Schwartz said in a note to investors. Schwartz wondered if the value is indicative of “a broader decline in PRV interest among bidders” or more narrowly of Sarepta’s failure to recognize the value of its asset.