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Tenax Therapeutics Achieves Major Milestone as USPTO Grants Notice of Allowance for U.S. Patent Application Covering Use of Oral Levosimendan (TNX-103) in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF)
Once granted, this patent will provide intellectual property protection until December 2040, and may qualify for additional U.S. patent term extension beyond
About this update from Tenax Therapeutics, Inc.
[{"type":"text","content":"Once granted, this patent will provide intellectual property protection until December 2040, and may qualify for additional U.S. patent term extension beyond 2040 There are currently no FDA approved treatments for PH-HFpEF, a condition affecting more than 1,600,000 North Americans, with estimates indicating a prevalence of more than 2,000,000 patients by 2030Once granted, this patent will significantly broaden Tenax’s U.S. intellectual property (IP) protection for a market with the potential to generate billions in future estimated annual sales Acting as both a potassium ATP channel activator and a calcium sensitizer, levosimendan is the only drug to show significant improvement in the 6-minute walk endpoint in this large patient population (Phase 2 HELP Study) Tenax intends to initiate a Phase 3 trial using this daily, oral formulation in 2023 CHAPEL HILL, N.C., May 31, 2023 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, announced today that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its patent application with claims covering the use of TNX-103, oral levosimendan, titled: “LEVOSIMENDAN FOR TREATING PULMONARY HYPERTENSION WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (PH-HFpEF).” The patent, once granted, will have a patent term through December 2040. It will provide the Company with substantial added intellectual property (IP) protection in the United States; Tenax will now have secured IP rights surrounding the use of oral, subcutaneous, and intravenous (IV) administration of levosimendan for the treatment of PH-HFpEF. “With this Notice of Allowance, Tenax is now exceptionally well-positioned to realize the significant commercial potential of oral levosimendan, based on this new IP protection that will last until at least the end of 2040. Advancing this daily, oral formulation into Phase 3 studies for the treatment of PH-HFpEF, a heart condition affecting millions of people in the United States with no FDA approved treatments, is our next step,” said Chris Giordano, Chief Executive Officer of Tenax Therapeutics. “I would like to thank my Tenax colleagues and our outside IP...