Tenax Therapeutics Gains North American Rights to Oral Levosimendan through Expanded License Agreement with Orion Corporation
October 15 2020 - 7:30AM
Business Wire
- Tenax gains developmental and commercial rights for a
fully-developed oral levosimendan formulation in the U.S. and
Canada
- Oral formulation expected to be used in upcoming Phase 3
registration trial
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.
Tenax 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.”
The 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.
The 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
The 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 distance.
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.
About Levosimendan
Levosimendan 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
This 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.
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Investor Contact: Westwicke Stephanie Carrington, 646-277-1282
Stephanie.carrington@westwicke.com
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