United Therapeutics announced that it has agreed to pay $105 million for a rare pediatric disease priority review voucher that the company plans to use to get an 8-month FDA review of an NDA for its Tyvaso treprostinil DPI instead of the standard 12-month review. Submission of the NDA for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease is planned for the first half of 2021, the company said.
In 2018, United Therapeutics announced that it was licensing the dry powder treprostinil from MannKind for $45 million up front plus milestone payments worth up to $50 million and double digit royalties. The formulation is based on MannKind’s Technosphere particle engineering technology and is delivered via the Dreamboat device. United Therapeutics has already made several milestone payments to MannKind under the agreement.
In June 2020, United Therapeutics filed a patent infringement suit against Liquidia Technologies following Liquidia’s submission of an NDA for its treprostinil DPI earlier in the year. The FDA issued a complete response letter to Liquidia’s NDA in November 2020.
United Therapeutics President and Chief Operating Officer Michael Benkowitz commented, “This acquisition affirms our commitment to bring a new generation of treatments to patients with pulmonary hypertension as quickly as possible. 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.”
Read the United Therapeutics press release.
