On November 19, 2020 MannKind Corporation (NASDAQ:MNKD) reported that it has achieved the final development milestone under its licensing and collaboration agreement with United Therapeutics for the development and commercialization of a dry powder formulation of treprostinil (Press release, Mannkind, NOV 19, 2020, View Source [SID1234571430]).
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Treprostinil Technosphere ("TreT") is an investigational product currently being evaluated in clinical trials for the treatment of pulmonary arterial hypertension (PAH). All current clinical trials are now fully enrolled, including the BREEZE study in patients with PAH and a pivotal pharmacokinetics study in healthy subjects, both of which are being conducted by United Therapeutics, as well as a human factors study being conducted by MannKind. In addition, MannKind’s stability program for TreT has reached the milestone required for a regulatory filing.
"We are looking forward to working with United Therapeutics during the first part of 2021 to prepare an FDA submission for TreT," said Michael Castagna, Chief Executive Officer of MannKind.
MannKind has now received all of the milestone payments that were specified in its agreement with United Therapeutics. MannKind remains entitled to receive low double-digit royalties on net sales of TreT. MannKind will also manufacture supplies of TreT for United Therapeutics and will earn a manufacturing margin.