MannKind and United Therapeutics Achieve a Major Milestone in the Development of Tyvaso DPI™ With New Drug Application Acce...
June 16 2021 - 6:15AM
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 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. 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 StatementsThis 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.
CONTACTS:
For MannKind:
Christie Iacangelo, Corporate Communications
(818) 292-3500
Email: media@mannkindcorp.com
Rose Alinaya, Investor Relations
(818) 661-5000
Email: ir@mannkindcorp.com
For United Therapeutics:
Dewey Steadman, Investor Relations
(202) 919-4097
Email: ir@unither.com
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