WESTLAKE VILLAGE, Calif.,
Aug. 4, 2021 /PRNewswire/ --
MannKind Corporation (Nasdaq: MNKD) has partnered with
NRx Pharmaceuticals (Nasdaq: NRXP) (NRx) to evaluate the
feasibility of formulating a dry powder formulation of
ZYESAMI™ (aviptadil), a synthetic form of human
Vasoactive Intestinal Peptide (VIP) – an endogenous substance
produced by the body that helps protect cells against inflammatory
conditions. An intravenous formulation of ZYESAMI is
currently in clinical trials, having been granted Fast Track
Designation by the U.S. Food and Drug Administration (FDA) for the
treatment of Critical COVID-19 with Respiratory Failure.
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"We continue to explore ways that our Technosphere technology
can deliver unique compounds in a targeted and convenient manner
for patients with serious lung diseases," said Michael Castagna, PharmD, Chief Executive
Officer of MannKind Corporation. "The novel coronavirus continues
to be a factor around the world, and we are just beginning to bear
witness to its long-term effects on the lungs."
Rapid recovery from Critical COVID-19 with Respiratory Failure
has been reported in patients treated with open label VIP under a
Phase 2b/3 clinical trial and in an
FDA Expanded Access Program. Emerging data indicates that VIP binds
uniquely to receptors on Alveolar Type II cells preventing cell
death, stopping replication of the coronavirus in the Type II cells
and upregulating the production of surfactant – the loss of which
is increasingly implicated in COVID-19 respiratory failure.
"As we continue to identify beneficial effects of VIP in
treating various respiratory disorders, development of a convenient
dosing method that offers stability at room temperature is key to
long term success," said Prof Jonathan
Javitt, MD, MPH, CEO and Chairman of the Board, of NRx. "We
are pleased to be working with MannKind to develop an inhaled form
of ZYESAMI which may offer patients an easier and more therapeutic
option."
MannKind will begin exploring formulation potential at its
research and manufacturing facility located in Danbury, Conn., which features a full range of
development and manufacturing capabilities, including analytical,
chemical, formulation, filling and packaging. It has sufficient
filling capacity to produce more than 300 million cartridges of
inhaled drug annually.
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. Afrezza is also available
by prescription in Brazil, where
it is commercialized by the Company's partner, Biomm SA. MannKind
was established in 1991, and is headquartered in Westlake Village, Calif., with a manufacturing
and R&D facility based in Danbury,
Conn. The Company also employs field sales and medical
representatives across the U.S. Please visit mannkindcorp.com
to learn more.
Forward-looking Statements
This press release contains
forward-looking statements that involve risks and uncertainties.
Words such as "plans," "expects," "intend," "will," "targeted,"
"potential" and similar expressions are intended to identify
forward-looking statements. Forward-looking statements include
statements regarding the potential to create a dry powder
formulation of a new compound and to treat certain diseases. Such
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, which
include, without limitation, the risk that continued testing of
product candidates may not yield successful results. These
and other risks are detailed in MannKind's filings with the
Securities and Exchange Commission ("SEC"), including under the
heading "Risk Factors" in MannKind's Quarterly Report on Form 10-Q
for the quarter ended March 31, 2021,
filed with the SEC on May 12, 2021.
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.
ZYESAMI is a trademark of NRx Pharmaceuticals, Inc.
AFREZZA and TECHNOSPHERE are registered trademarks of MannKind
Corporation.
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SOURCE MannKind Corporation