MannKind Receives Fourth $12.5 Million Milestone Payment from United Therapeutics
November 19 2020 - 5:00PM
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
CorporationMannKind 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:818-661-5000ir@mannkindcorp.com
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