United Therapeutics Corp. recently sold a voucher for fast-track Food and Drug Administration review to AbbVie for a record $350 million. The secondary market for the vouchers highlights the industry's growing thirst to get to market with the next potential blockbuster therapy.
The voucher allows AbbVie to have one of its drugs reviewed by the FDA in a six-month time frame as opposed to the standard 10-month period. United Therapeutics received the priority-review voucher as part of an FDA program designed to encourage drug companies to develop treatments for diseases where the development costs would be prohibitive.
The FDA grants a voucher as a reward when a company develops and gets approval for a treatment of one of 17 tropical diseases or develops a therapy for a rare pediatric condition that affects more than 50% of those under the age of 18 and has fewer than 200,000 U.S. cases, according to the agency's guidance.
United Therapeutics was awarded its priority review voucher when its drug Unituxin was approved in March for the treatment of neuroblastoma, a rare type of cancerous tumor that accounts for as many as 10% of pediatric cancers.
A voucher holder can either redeem it to expedite review of one of its other drugs or, as is often the case, turn around and sell it to another company.
Since the inception of the program in 2007 the FDA has granted priority review vouchers to six companies. Only one—Novartis—has attempted to use its voucher for one of its own drugs. The Swiss-based firm was the first to be awarded a voucher, in 2009, after getting approval for its multidrug-resistant malaria treatment Coartem. Novartis used the voucher to accelerate review of its drug Ilaris for gouty arthritis, only to see regulators reject it in 2011 for that particular indication.
Since that time, four companies have opted to sell their vouchers to other firms, and the price has gone up with each transaction. The first, sold by California-based BioMarin Pharmaceutical, was purchased by Sanofi and Regeneron for $67 million in 2014. In May, Sanofi bought a voucher from Baltimore-based Asklepion Pharmaceuticals for $245 million. That was the record until this latest purchase by AbbVie.
AbbVie has yet to disclose what it intends to do with the voucher. Calls to the company seeking comment were not returned Thursday.