- Hoping to speed up future regulatory review for its drug candidates, Gilead has agreed to buy a priority review voucher from Sarepta Therapeutics for $125 million, according to a regulatory document filed by Sarepta.
- Sarepta had obtained the voucher — a transferrable credit designed to speed review by the Food and Drug Administration by four months — for winning approval of its disease-modifying treatment for Duchenne muscular dystrophy (DMD) last year.
- The price paid by Gilead, while still steep, is well below the $200 million plus fetched in previous sales of priority review vouchers. AbbVie, for example, paid United Therapeutics a princely $350 million for one in 2015.
This isn't the first time Gilead has raided the bank to pick up one of the coveted priority review vouchers. The large biotech paid a similar $125 million to acquire one from Knight Therapeutics in March 2014 and a regulatory filing from last summer disclosed the purchase of another for an undisclosed price.
Backing out other known costs from Gilead's estimates in that regulatory document, it is likely Gilead paid somewhere in the $200 million or below range for that second voucher, according to EP Vantage's Jacob Plieth.
Pharmaceutical companies are willing to pay up for the vouchers because use of one can shave off four months from the FDA's usual regulatory review period of 10 months. That additional time on market can be vital for securing market share ahead of competitors.
Sanofi and Regeneron, for example, used a priority review voucher they obtained from BioMarin to speed up review of their PCSK9 inhibitor Praluent (alirocumab), which was approved a month ahead of Amgen's rival Repatha.
Sanofi used another voucher, bought from Retrophin for $245 million in 2015, in an effort to get its insulin/GLP-1 combination treatment approved before a rival product from Novo Nordisk. The FDA, however, asked Sanofi for more information on the combo, delaying approval. Both Sanofi's and Novo's products were approved last November.
Sarepta had received its voucher from the FDA under a program designed to speed development of neglected or rare pediatric diseases. Developers of drugs for designated conditions receive a priority review voucher upon approval and can then sell or use that voucher. Another parallel program provides the same incentive to developers of drugs for rare tropical diseases.
Sale of the voucher, albeit for a lower price than some had expected, will bolster Sarepta's cash position and help fund clinical development of Sarepta's pipeline and manufacturing scale-up, company CFO Sandy Mahatme said on a recent earnings call.
For Gilead, the voucher could be used to speed review for one of its several late-stage candidates. The $125 million is a relative bargain as well, compared to both the recent prices paid by Sanofi and AbbVie as well as to Gilead's large cash hoard.