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newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20201119:nGNXbHyT3v WESTLAKE VILLAGE, Calif., Nov. 19, 2020 (GLOBE NEWSWIRE) -- MannKind
Corporation (NASDAQ:MNKD) today announced 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.
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.
About MannKind Corporation
MannKind Corporation (NASDAQ: MNKD) focuses on the development and
commercialization of inhaled therapeutic products for patients with endocrine
and orphan lung diseases. MannKind is currently commercializing Afrezza®
(insulin human) Inhalation Powder, the Company’s first FDA-approved product
and the only inhaled ultra rapid-acting mealtime insulin in the United
States, where it is available by prescription from pharmacies
nationwide. MannKind is headquartered in Westlake Village, California, and
has a state-of-the art manufacturing facility in Danbury, Connecticut. The
Company also employs field sales and medical representatives across
the U.S. For further information, visit
www.mannkindcorp.com .
Forward-Looking Statements
This press release contains forward-looking statements that involve risks and
uncertainties. Words such as "believes," "anticipates," "plans," "expects,"
"intends," "will," "goal," "potential" and similar expressions are intended to
identify forward-looking statements. These forward-looking statements are
based upon MannKind's current expectations. Actual results and the timing of
events could differ materially from those anticipated in such forward-looking
statements as a result of various risks and uncertainties detailed
in MannKind's filings with the SEC. For a discussion of these and other
factors, please refer to MannKind’s annual report on Form 10-K for the year
ended December 31, 2019 as well as MannKind’s other filings with the SEC.
You are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date of this press release. All
forward-looking statements are qualified in their entirety by this cautionary
statement, and MannKind undertakes no obligation to revise or update any
forward-looking statements to reflect events or circumstances after the date
of this press release.
Company Contact:
818-661-5000
ir@mannkindcorp.com
(https://www.globenewswire.com/NewsRoom/AttachmentNg/02506201-22d2-4fde-af6b-fec5dcd6d367
)
GlobeNewswire, Inc. 2020
Rank : positive
