United Therapeutics Corporation (Nasdaq: UTHR) announced today an agreement to acquire a Rare Pediatric Disease Priority Review Voucher (PRV), which it plans to use with a forthcoming New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). The PRV entitles the holder to designate an NDA for priority review and provides for an expedited eight-month review, instead of the standard twelve-month review period. Following the close of the transaction, United Therapeutics intends to apply the PRV to its NDA for Tyvaso DPI, expected in the first half of 2021.
"This acquisition affirms our commitment to bring a new generation of treatments to patients with pulmonary hypertension as quickly as possible," said Michael Benkowitz, President and Chief Operating Officer of United Therapeutics. "Once approved, Tyvaso DPI with the innovative Dreamboat® device is expected to be a major advancement in the delivery of inhaled treprostinil therapy, offering substantial convenience compared to the existing Tyvaso nebulizer."
United Therapeutics has entered into a definitive agreement to purchase the PRV for $105 million. The closing of the transaction is subject to customary closing conditions, including obtaining expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvement Act of 1976.
About Tyvaso DPI
Tyvaso DPI, previously referred to as Treprostinil Technosphere®, is an investigational drug-device combination product comprised of a dry powder formulation of treprostinil and a small, portable, dry powder inhaler. If approved, Tyvaso DPI is expected to provide a more convenient method of administration as compared with traditional nebulized Tyvaso therapy. United Therapeutics is developing Tyvaso DPI under a collaboration and license agreement with MannKind Corporation. Tyvaso DPI incorporates the dry powder formulation technology and Dreamboat inhalation device technology used in MannKind's Afrezza® (insulin human) Inhalation Powder product, approved by the FDA in 2014.
