Kitov Granted Notice of Allowance from U.S. Patent & Trademark Office for KIT-302

TEL AVIV, Israel, February 1, 2017 /PRNewswire/ --

Patent Further Strengthens Company's IP position ahead of Planned New Drug Application to be Submitted to FDA

Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, announced today that the U.S. Patent and Trademark Office has issued a Notice of Allowance to the Company related to claims expanding the patent coverage for its lead drug candidate, KIT-302, to include oral dosage compositions containing both amlodipine and celecoxib. 

"This Notice of Allowance should result in the issuance of an additional patent, which is expected to further strengthen Kitov's proprietary position and long-term U.S. market exclusivity for our lead compound, KIT-302, creating a higher barrier to entry for potential competitors. We plan to continue to evaluate and grow intellectual property rights of our amlodipine/celecoxib combination platform," stated Kitov CEO, Isaac Israel.  

Mr. Israel further noted, "The preparation of our New Drug Application (NDA) for KIT-302 to be submitted to the U.S. Food and Drug Administration is continuing and is expected to be completed within the first quarter of 2017, as scheduled."

About the Additional Patent Allowance for KIT-302 

In August 2016, Kitov Pharmaceuticals, Ltd., Kitov's wholly owned subsidiary, was awarded U.S. Patent 9,408,837.  That patent covers methods of ameliorating celecoxib-induced elevation of blood pressure by providing a subject with celecoxib and amlodipine, where the amlodipine reduces blood pressure elevation caused by the celecoxib.  Kitov Pharmaceuticals, Ltd. has now obtained a Notice of Allowance on a continuation application filed from the application which yielded Patent 9,408,837.  The new patent, which is expected to issue from the continuation application in the next few months, is expected to expand the sphere of protection over Kitov's amlodipine/celecoxib combination therapy by having claims which cover oral dosage compositions containing both amlodipine and celecoxib.  Examples of oral dosage compositions include capsules, gelcaps, caplets, tablets, and liquids.  These claims are expected to cover oral dosage compositions containing both the combination of amlodipine and celecoxib alone or together with other compounds or ingredients. 

About Kitov Pharmaceuticals  

Kitov Pharmaceuticals (NASDAQ/TASE: KTOV) is an innovative biopharmaceutical drug development company. Leveraging deep regulatory and clinical-trial expertise, Kitov's veteran team of healthcare and research professionals maintains a proven track record in streamlined end-to-end drug development and approval. Kitov's flagship combination drug, KIT-302, intended to treat osteoarthritis pain and hypertension simultaneously, achieved the primary efficacy endpoint for its Phase III clinical trial. KIT-302's New Drug Application with the U.S. Food and Drug Administration is currently being prepared for submission. Kitov's newest drug NT219, a potential immuno-oncology combination product, is being developed by Kitov's recently acquired subsidiary, TyrNovo Ltd. NT219 is a small molecule that presents a new concept in cancer therapy. In combination with various approved oncology drugs, NT219 demonstrated potent anti-tumor effects and increased survival in various cancer models, including sarcoma, melanoma, pancreatic, lung, ovarian, head & neck, prostate and colon cancers. Its mechanism of action is through the prevention of acquired resistance in tumors and by regression of resistant tumors. By lowering development risk and cost, including via fast-track regulatory approval of novel late-stage and other therapeutics, Kitov plans to deliver rapid ROI and long-term potential to investors, while making a meaningful impact on people's lives. For more information on Kitov, the content of which is not part of this press release, please visit http://www.kitovpharma.com.  

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CONTACT:
Simcha Rock
Chief Financial Officer
+972-3-9333121 ext. #105
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Bob Yedid
Managing Director
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SOURCE Kitov Pharmaceuticals Holdings Ltd.