August 19, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Silver Spring, Md.-based United Therapeutics Corporation announced today that it has agreed to sell its Rare Pediatric Disease Priority Review Voucher (PPRV) to a subsidiary of Chicago-based AbbVie for $350 million.
In 2014 the U.S. Food and Drug Administration (FDA)’s Safety and Innovation Act (FDASIA) added a section to the Federal Food, Drug, and Cosmetic Act that awarded priority review vouchers to sponsors of rare pediatric disease product applications that fell into certain specific categories. The voucher can then be used to gain priority review or, as is sometimes the case, sell the voucher to another company to use. Priority review cuts the review process from about 10 months to about six.
United Therapeutics received the voucher when its drug, Unituxin, was approved for the treatment of neuroblastoma, a rare pediatric cancer.
Earlier this year Sanofi and Regeneron Pharmaceuticals, Inc. acquired a priority review voucher from BioMarin Pharmaceutical Inc. for $67.5 million. BioMarin received the voucher early in 2014 related to Vimizim, a drug for a rare pediatric condition, Morquio A syndrome.
In May 2015, Sanofi acquired a PRV from San Diego, Calif.-based Retrophin for a total of $245 million over two years. The first payment was immediate, for $150 million, followed by two installments of $47.5 each in 2016 and 2017.
In 2014, Knight Therapeutics sold a voucher to Gilead Sciences AG for $125 million. Knight Therapeutics, a Canadian company, received the voucher at the approval of Impavido, to treat the parasite leishmaniasis.
“We are very pleased to monetize our PPRV, and hope that this transaction will encourage others to join us in focusing development efforts on rare pediatric diseases,” said Roger Jeffs, president and co-chief executive officer of United Therapeutics in a statement.
On Monday, United Therapeutics announced that Unituxin had been granted Marketing Authorization by the European Commission (EC). The drug is given in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and isotretinoin. The approval was based on a multicenter, open-label, randomized trial (ANBL0032) sponsored by the U.S. National Cancer Institute under a Cooperative Research and Development Agreement with United Therapeutics. The trial was conducted by the Children’s Oncology Group (COG).
Overall, has been on an increase over the last year. Shares traded on Sept. 5, 2014 for $112.16, rose to $146.70 on Jan. 21, 2015, and again to $188.56 on April 23. Shares dropped to $159.69 an April 30, then bounced back to $188.41 on June 22. They have since settled, trading today for $165.15.
United Therapeutics has not stated what they will use the $350 million for, and AbbVie has not indicated its intentions for the voucher. For companies in a competitive race to hit the market with a product, the voucher can provide a couple months’ lead time if the product gets approval.
At its recent second quarter financial results, United Therapeutics indicated $347.1 million in second quarter revenue, up from $322.8 million in the same quarter in 2014. Revenues are being driven by the sales of Orenitram. “Orenitram sales grew nearly 300 percent as compared to the second quarter of 2014 when the product was first launched,” said Jeffs in a statement. “The growth in Orenitram sales was due to an increase in the number of patients being treated, which strengthens our belief in the organic growth opportunity of our orally-administered prostacyclin analogue.”
Orenitram is the first and only FDA-approved oral prostacyclin class drug for the treatment of pulmonary arterial hypertension (PAH), or high blood pressure in the arteries in the lungs.
