Full Press Release Details
Tenax Therapeutics Gains North American Rights to Oral Levosimendan
through Expanded License Agreement with Orion
Tenax gains developmental and commercial rights for a
fully-developed oral levosimendan formulation in the U.S. and
Oral formulation expected to be used in upcoming Phase 3
Morrisville, NC, October 15, 2020 - Tenax Therapeutics, Inc.
(Nasdaq: TENX), a specialty
pharmaceutical company focused on identifying, developing, and
commercializing products for the critical care market, today
announced that it has entered into an amendment to the existing
licensing agreement with Orion Corporation to include the rights to
develop and commercialize in the United States and Canada an oral
formulation of levosimendan for use with Type 2 pulmonary
hypertension in heart failure patients with preserved ejection
fraction (PH-HFpEF), or other pulmonary hypertension or heart
failure related indications. The Company recently completed a Phase
2 study in PH-HFpEF using an intravenous formulation of
levosimendan, which the Company has exclusive development and
commercialization rights to in the US and Canada under the existing
license agreement. The Company now plans to utilize the oral
formulation in its upcoming Phase 3 trial in PH-HFpEF. Currently,
there are no approved products for treating PH-HFpEF.
CEO Anthony DiTonno stated Adding the oral formulation to
our existing agreement represents a significant opportunity for us.
Use of the currently available 1mg capsule of levosimendan should
allow us to conduct our upcoming Phase 3 trial with significantly
faster enrollment versus the IV formulation. We expect an oral
formulation will also enable us to enjoy greater market acceptance
upon FDA approval for marketing .
oral formulation is a fully developed capsule that has already been
used in a large number of patients over an extended period of time,
up to one year in many cases. The amendment allows Tenax to access
all of the manufacturing, preclinical and clinical data generated
on oral levosimendan to support its use in the US and Canada, which
we anticipate will expedite development efforts.
Company intends to review its plans to use the oral levosimendan
formulation in a Phase 3 trial in PH-HFpEF patients with the FDA
during its End-of-Phase 2 meeting.
About Phase 2 HELP Trial
HELP Study (Hemodynamic Evaluation of Levosimendan in PH-HFpEF) was
a multi-center, double-blind, placebo-controlled Phase 2 clinical
trial designed to evaluate levosimendan in 36 patients with
pulmonary hypertension and heart failure with preserved ejection
fraction (PH-HFpEF). Endpoints in the trial evaluated various
invasive hemodynamic and clinical measures including a 6-minute
walk test. The Company previously announced positive topline
results from this Phase 2 trial. The trial demonstrated significant
reduction in right atrial and pulmonary capillary wedge pressures.
It also demonstrated a significant improvement with 6-minute walk
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical company
focused on identifying, developing, and commercializing products
that address cardiovascular and pulmonary diseases with high unmet
medical need. The Company has a world-class scientific advisory
team including recognized global experts in pulmonary hypertension.
The Company owns North American rights to develop and commercialize
levosimendan and has recently released topline data regarding their
Phase 2 clinical trial for the use of levosimendan in the treatment
of Pulmonary Hypertension associated with Heart Failure and
preserved Ejection Fraction (PH-HFpEF). For more information,
visit www.tenaxthera.com.
is a calcium sensitizer that works through a unique triple
mechanism of action. It initially was developed for intravenous use
in hospitalized patients with acutely decompensated heart failure.
It was discovered and developed by Orion Pharma, Orion Corporation
of Espoo Finland, and is currently approved in over 60 countries
for this indication and not available in the United States. Tenax
Therapeutics acquired North American rights to develop and
commercialize levosimendan from Phyxius Pharma, Inc.
Caution Regarding Forward-Looking Statements
news release contains certain forward-looking statements by the
Company that involve risks and uncertainties and reflect the
Company's judgment as of the date of this release. The
forward-looking statements are subject to a number of risks and
uncertainties, including, but not limited to matters beyond the
Company's control that could lead to delays in the clinical
study including delays in patient enrollment, new product
introductions and customer acceptance of these new products;
matters beyond the Company's control that could impact the
Company's continued compliance with Nasdaq listing
requirements; the impact of management changes on the
Company's business and unanticipated charges, costs and
expenditures not currently contemplated that may occur as a result
of management changes; and other risks and uncertainties as
described in the Company's filings with the Securities and
Exchange Commission, including in its annual report on Form 10-K
filed on March 30, 2020, and its quarterly report of Form 10-Q
filed on August 14, 2020, as well as its other filings with the
SEC. The Company disclaims any intent or obligation to update these
forward-looking statements beyond the date of this release.
Statements in this press release regarding management's
future expectations, beliefs, goals, plans or prospects constitute
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995.
Carrington, 646-277-1282