KTOV: If True and of Substance, Not So Good

Kitov Submits New Drug Application to FDA for KIT-302



TEL AVIV, Israel, July 31, 2017 /PRNewswire/ --



Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV, TASE: KTOV), an innovative biopharmaceutical company, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for KIT-302, its lead drug candidate. KIT-302 is a patented combination of celecoxib and amlodipine, and is intended to treat osteoarthritis pain and hypertension simultaneously.



The company expects that within 60 days the FDA will determine whether the NDA is complete and acceptable for filing.



“We are pleased with the dedicated, professional work of our staff, investigators, and CROs. We look forward to working with FDA as it reviews the NDA,” stated J. Paul Waymack, M.D., Sc.D., Kitov's Chairman of the Board and Chief Medical Officer. “We are on track to meet our anticipated Prescription Drug User Fee Act (PDUFA) dates with respect to FDA filing the NDA in the third quarter of 2017, and rendering a decision on approval for marketing of KIT-302 during the second quarter of 2018.”



Dr. Waymack added, “The data in KIT-302’s pivotal Phase III clinical trial were generated, collected, validated and analyzed by leading independent clinical research organizations, service providers, as well as expert clinical investigators. The data demonstrated that the Phase III study of KIT-302 met its primary endpoint with statistical significance of p=0.001.”



About Kitov Pharmaceuticals



Kitov Pharmaceuticals (NASDAQ: KTOV, TASE: KTOV) is an innovative biopharmaceutical drug development company. Leveraging deep regulatory and clinical-trial expertise, Kitov's veteran team of healthcare 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. Kitov's newest drug, NT219, which is developed by its majority owned subsidiary, TyrNovo Ltd., is a small molecule that presents a new concept in cancer therapy, and in combination with various approved oncology drugs, demonstrated potent anti-tumor effects and increased survival in various cancer models. By lowering development risk and cost through fast-track regulatory approval of novel 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 www.kitovpharma.com.