Mannkind and United Therapeutics Reach a Milestone in the Development of Tyvaso DPI™ With New Drug Application Submitted to...
April 19 2021 - 6:00AM
MannKind Corporation (Nasdaq: MNKD) and United Therapeutics
(Nasdaq: UTHR) reached a milestone today in the development of
Tyvaso DPI™ as United Therapeutics submitted a new drug application
(NDA) to the U.S. Food and Drug Administration (FDA).
“The NDA submitted today by United Therapeutics builds upon a
drug master file previously submitted by MannKind,” said Michael
Castagna, CEO of MannKind Corporation. “We are excited to see the
second compound formulated with our technology complete a rigorous
clinical development program. If approved by the FDA, Tyvaso DPI is
expected to provide a major advancement in the delivery of inhaled
treprostinil for PAH and PH-ILD patients.”
MannKind and United Therapeutics entered into a worldwide
exclusive licensing and collaboration agreement in September 2018
for the development and commercialization of Tyvaso DPI, a dry
powder formulation of treprostinil, delivered via a small, portable
dry powder inhaler. 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.
Tyvaso DPI, if approved, is expected to provide a convenient
choice of inhaled administration for patients with pulmonary
arterial hypertension (PAH) and pulmonary hypertension associated
with interstitial lung disease (PH-ILD). There are approximately
45,000 treated PAH patients in the U.S. and United Therapeutics
estimates at least 30,000 treatable PH-ILD patients in the U.S.
United Therapeutics has applied a priority review voucher to the
NDA that could provide for an FDA decision by December 2021. The
FDA must first accept the application for review and issue a formal
decision date in accordance with the Prescription Drug User Fee
Act.
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 the patient track
information about inhaler use.
Tyvaso DPI is an investigational therapy that is not approved
for any use in any country or indication and the Tyvaso DPI
tradename is pending final FDA review.
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 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
state-of-the-art manufacturing 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, 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: |
For United Therapeutics: |
Christie Iacangelo, Corporate
Communications |
Dewey Steadman, Investor
Relations |
(818) 292-3500 |
(202) 919-4097 |
Email:
media@mannkindcorp.com |
Email: ir@unither.com |
Rose Alinaya, Investor Relations(818) 661-5000Email:
ir@mannkindcorp.com
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