United Therapeutics and MannKind established a worldwide exclusive licensing and agreement to develop and commercialize a dry powder formulation of treprostinil, an approved vasodilator, for pulmonary arterial hypertension (PAH) that is now being tested along with the Technosphere inhalation device (a drug delivery system).
The agreement gives MannKind the responsibility to manufacture clinical supplies and initial commercial supplies of the treprostinil-Technosphere (TreT) product at its manufacturing facilities in Danbury, Connecticut.
United Therapeutics will be responsible for the global development of TreT, including long-term commercial supplies, and regulatory and commercial activities.
“We are excited to partner with United Therapeutics, a company that shares our passionate focus on changing patients’ lives,” Michael Castagna, MannKind CEO, said in a press release.
“We are pleased with this new opportunity to demonstrate the value of our drug and device combination platform for delivering therapeutic products. We believe this collaboration will have the potential to significantly improve the lives of people living with pulmonary arterial hypertension,” Castagna said.
Preliminary positive safety data in MannKind’s Phase 1 clinical study (NCT03464864) showed that treprostinil was safely delivered at varying doses using the Technosphere inhalation device. The trial, which started enrolling patients in March, is still recruiting participants to advance the TreT clinical program.
As part of the agreement, MannKind will receive an immediate payment of $45 million from United Therapeutics and potential milestone payments of up to $50 million, depending on the results of specific development goals. During the initial phase, MannKind also will receive royalties from the commercialization of the product.
The agreement includes the opportunity for United Therapeutics to expand the license to other active ingredients for the treatment of pulmonary hypertension, with a price of up to $40 million, as well as royalties, per product added to the license.
The companies will seek products outside the scope of the licensing and collaboration agreement. For this purpose, MannKind will receive an upfront payment of $10 million to advance research for new therapies.
According to Martine Rothblatt, PhD, chairman and CEO of United Therapeutics, “as we now move into the second generation of United Therapeutics products, we are proud to once again team with Al Mann’s brilliance, this time with his Dreamboat, Bluhale and Cricket devices for inhalation.”
Alfred (Al) Mann, chairman emeritus at MannKind, was a pioneer in medical devices.
Rothblatt is very confident on the success of the TreT clinical program. “These revolutionary new inhalation devices” she said, represent a “further step toward a next generation of treprostinil drug-device systems that enhance options for patients, their families and their prescribers.”