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Tenax Therapeutics Gains North American Rights to Oral Levosimendan through Expanded License Agreement with Orion Corporation
Tenax gains developmental and commercial rights for a fully-developed oral levosimendan formulation in the U.S. and Canada Oral formulation expected to be
About this update from Tenax Therapeutics, Inc.
[{"type":"text","content":"\n\nTenax gains developmental and commercial rights for a fully-developed oral levosimendan formulation in the U.S. and Canada\n\n\nOral formulation expected to be used in upcoming Phase 3 registration trial\n\n\n MORRISVILLE, N.C.--(BUSINESS WIRE)--\nTenax 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.\n\nTenax 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.”\n\nThe 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.\n\nThe 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.\n\nAbout Phase 2 HELP Trial\n\nThe HELP Study (Hemodynamic Evaluation of Levosimendan in PH-HFpEF) was a multi-center, double-b...