TEL AVIV, Israel, December 7, 2016 /PRNewswire/ —
Kitov Pharmaceuticals Holdings Ltd. (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company focused on late stage drug development, announced today that its lead drug candidate KIT-302 met the U.S. Food and Drug Administration’s (FDA) standards for establishing six months stability.
The study, conducted by Kitov’s manufacturing partner, Dexcel Pharma, demonstrated that nine pivotal batches of KIT-302, three in each dosage forms (celecoxib/amlodipine of 200 mg/10 mg, 200 mg/5 mg, and 200 mg/2.5 mg) met the criteria demonstrating stability for 6 months. The successful stability study enables registration batches of KIT-302 to be included in the New Drug Application (NDA) submission which is planned during Q1 2017. The Certificate of Analysis demonstrated adequate stability required for submission, in accordance with FDA guidelines. Kitov expects to submit additional stability data to the FDA at a later time, in order to extend the labeled shelf life.
“We are very pleased with the stability study results, which we believe complete the testing required for our New Drug Application to the FDA for KIT-302,” stated Dr. J. Paul Waymack, Chairman of Kitov’s Board and Chief Medical Officer.
KIT-302 is a fixed dose combination consisting of 200 mg of celecoxib, indicated for osteoarthritis pain, and 2.5, 5 or 10 mg of amlodipine, indicated for high blood pressure. It is intended to treat pain caused by osteoarthritis (OA), as well as simultaneously treat hypertension, which is a common side effect of certain stand-alone drugs that treat osteoarthritis pain, as well as a common concomitant preexisting condition. KIT-302 is comprised of two U.S. Food and Drug Administration (FDA) approved drugs, celecoxib (the active ingredient in Pfizer’s Celebrex®), for the treatment of pain caused by osteoarthritis and amlodipine besylate (the active ingredient in Pfizer’s Norvasc®), a drug designed to treat hypertension. Kitov expects to submit a New Drug Application for KIT-302, which successfully completed a pivotal Phase III trial, with the U.S. Food and Drug Administration during Q1 2017.
Celebrex® is a registered trademark of G.D. Searle LLC (a subsidiary of Pfizer Inc.). Norvasc® is a registered trademark of Pfizer Inc.
About Kitov Pharmaceuticals
Kitov Pharmaceuticals (NASDAQ/TASE: KTOV) is an innovative biopharmaceutical company focused on late-stage drug development. 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 and its New Drug Application with the U.S. Food and Drug Administration is currently being prepared for submission. By lowering development risk and cost through fast-track regulatory approval of novel late-stage 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.