RESEARCH TRIANGLE PARK – United Therapeutics, which has a big operation in RTP, is paying $105 million to acquire a voucher that it says will accelerate its New Drug Application process with the FDA.
The Maryland-based company (Nasdaq: UTHR) announced the deal for the so-called Priority Review Voucher early Monday. It did not disclose the selling party for the voucher.
In the first half of 2021, United plans to submit a NDA for Tyvaso which it describres as “an investigational drug-device combination product comprised of a dry powder formulation of treprostinil and a small, portable, dry powder inhaler.” Treatment targets are “pulmonary arterial hypertension (PAH), as well as pulmonary hypertension associated with interstitial lung disease (PH-ILD),” the company says.
United is familiar with the voucher process based in part on previous experience.
“It’s important to note that we sold a similar PRV a few years ago for $350 million and we’re purchasing essentially the same thing back for $105 million (albeit from a different party),” said Dewey Steadman, head of investor relations for United Therapeutics, via email.
“PRVs allow the holder to expedite the traditional FDA review process by four months. So the total time from submission to potential approval goes from 12 months to eight months in the case of Tyvaso DPI.”
