DANBURY, Conn., June 16, 2021 /PRNewswire/ -- MannKind
Corporation (Nasdaq: MNKD) and United Therapeutics Corporation
(Nasdaq: UTHR) reached a major milestone today with the
announcement that the U.S. Food and Drug Administration (FDA)
accepted for priority review of the New Drug Application (NDA) for
Tyvaso DPI™ (inhaled treprostinil) for the treatment of pulmonary
arterial hypertension (PAH) and pulmonary hypertension associated
with interstitial lung disease (PH-ILD). The development marks the
second compound formulated with MannKind's Technosphere®
technology to be reviewed by the FDA, which is expected to be
complete in October 2021. The FDA has also indicated that
they have not identified any potential review issues at this
time.
A next-generation formulation of treprostinil, Tyvaso DPI
incorporates the dry powder formulation technology and
Dreamboat® inhalation device technology used in
MannKind's Afrezza® (insulin human) Inhalation
Powder, which was approved by the FDA in 2014. MannKind and United
Therapeutics are also developing BluHale®, a
Bluetooth-connected accessory for the Tyvaso DPI inhaler with a
companion mobile application intended to help patients track
information about their inhaler use.
"We are energized by the acceptance of the Tyvaso DPI NDA for
priority review," said Michael
Castagna, PharmD, Chief Executive Officer of MannKind
Corporation. "MannKind is driven to deliver therapeutics in
ways that can help improve patient lives for the better. With this
key regulatory step, we are excited to progress the next
Technosphere product towards providing thousands of PAH and PH-ILD
patients a more convenient method of treprostinil therapy
administration."
MannKind and United Therapeutics entered into a worldwide
exclusive licensing and collaboration agreement in September 2018 for the development and
commercialization of Tyvaso DPI. In its communications with United
Therapeutics, the FDA indicated that approval of the NDA will be
subject to an inspection of the Tyvaso DPI manufacturing facility
operated by MannKind; FDA and MannKind have jointly targeted the
third quarter of 2021 to complete the inspection.
The NDA includes data from the BREEZE clinical study
that demonstrated safety and tolerability of Tyvaso DPI in patients
with PAH transitioning from Tyvaso® (treprostinil)
Inhalation Solution. A separate study in healthy volunteers
demonstrated comparable treprostinil exposure between Tyvaso DPI
and Tyvaso Inhalation Solution.
MannKind is entering an expansion phase as it prepares to
transition from producing clinical supply to building pre-launch
inventory of Tyvaso DPI, pending FDA approval. The company's
manufacturing and R&D facility in Danbury is scaling up by hiring more than 100
positions, as well as readying essential equipment and production
lines. A variety of MannKind jobs in commercial manufacturing,
engineering, quality control, warehouse operations, maintenance,
and more are currently open and planned to be filled this year.
Positions include both non-exempt and exempt positions.
"It's exciting to bring growth and expansion to Danbury and the surrounding communities as
MannKind continues to build upon its Technosphere®
technology," said Joe Kocinsky, MS,
MBA, Chief Technology Officer of MannKind Corporation. "Our site
will practically double in size as we spend the next months
preparing for Tyvaso DPI, pending FDA approval."
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,
including statements regarding MannKind's expected use of proceeds
from the offering. Words such as "believes", "anticipates",
"plans", "expects", "intend", "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 these risks and
uncertainties, which include, without limitation, uncertainties
regarding the regulatory approval process, the level of
preparedness for an inspection by a regulatory agency, challenges
encountered during the scale up of manufacturing operations, and
other risks detailed in MannKind's filings with the Securities
and Exchange Commission, including its Annual Report on Form 10-K
for the year ended December 31, 2020 and subsequent
periodic reports on Form 10-Q and current reports on Form 8-K.
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.
TYVASO is a registered trademark of United Therapeutics
Corporation.
TYVASO DPI is a trademark of United Therapeutics
Corporation.
AFREZZA, BLUHALE, TECHNOSPHERE and DREAMBOAT are registered
trademarks of MannKind Corporation.
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SOURCE MannKind Corporation