Business
Tenax Therapeutics Issued U.S. Patent for Oral Levosimendan in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF)
New U.S. patent provides intellectual property (IP) protection until December 2040, and may qualify for term extension beyond 2040There are currently no
About this update from Tenax Therapeutics, Inc.
[{"type":"text","content":"New U.S. patent provides intellectual property (IP) protection until December 2040, and may qualify for term extension beyond 2040There 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 2030Broadens Tenax’s U.S. IP protection for a market with the potential to generate billions in future estimated annual salesLevosimendan is the only drug to show statistically 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 TNX-103 (oral levosimendan) in 2023 CHAPEL HILL, N.C., July 19, 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 the United States Patent and Trademark Office (USPTO) has granted a new method of use patent for oral levosimendan (TNX-103) in the treatment of pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF), expiring in 2040. The issued patent (U.S. Patent No. 11,701,355) covers the use of oral levosimendan for the treatment of PH-HFpEF and provides exclusivity through December 2040. The ‘355 patent further builds upon the Company’s substantial IP, which also includes issued U.S. patents for the use of intravenous (U.S. Patent No. 11,607,412) and subcutaneous (U.S. Patent No. 11,213,524) formulations of levosimendan for the treatment of PH-HFpEF. \"The issuance of patent ‘355 is a very important achievement in protecting the discoveries made with the HELP Study, while also preserving for our shareholders the substantial commercial value of potentially developing the first drug to treat this large and underserved patient population,” said Chris Giordano, Chief Executive Officer of Tenax Therapeutics. “With this patent now in hand, providing us a potential commercial runway to December 2040, we are excited to be moving into Phase 3 testing with the oral formulation, where we hope to demonstrate the ability of TNX-103 to address this significant unmet need in patients with PH-HFpEF.” Stuart Rich MD, Chief Medical Officer of Tenax Therapeuti...