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Treat and Trade: The New Priority Review Voucher Market

This article was originally published in RPM Report

Executive Summary

Starting in September, pharmaceutical companies will have the opportunity to buy the right to a faster FDA review on the open market. If it works, the priority review voucher program could revolutionize development of drugs for neglected diseases, while increasing the value of more traditional commercial products in the US.

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Priority Review Vouchers: Buyers Beware!

The recent series of sales of priority review vouchers at ever-higher prices has transformed what had seemed to be a failed incentive model into a hot topic. However, one key stakeholder is not celebrating the recent developments: the FDA review teams that have to deliver the faster paced reviews continue to have strong reservations about the program.

Gilead Puts High Premium On Priority Review Voucher; Deal May Help Protect Lead In HCV

Gilead pays $125 million for the right to a faster review of a future product, doubling the price paid in the first priority review voucher sale just months before. The value of the voucher may go up if pending legislation is signed into law – but the high price tag speaks volumes about the importance of maintaining the lead in Hep C formulation development.

PCSK9 Meets PRV: Regeneron’s $70 Mil. Bid To Catch Up To Amgen

Regeneron and its partner Sanofi have become the first biopharma companies to buy a Priority Review Voucher. The $67 million price is a nice bonus for the seller, BioMarin, but probably not the start of a big new market for PRVs.

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