Kitov Pharma appoints Kuhnil Pharmaceutical Co. Ltd to market KT 302 in South Korea for osteoarthritis, with hypertension reduction.

Kitov Pharmaceuticals Holdings Ltd. an innovative biopharmaceutical company, announced that the Company has signed a definitive License Agreement for its lead product candidate, KIT 302, which was developed to simultaneously treat pain caused by osteoarthritis and to treat hypertension, for the territory of South Korea with Kuhnil Pharmaceutical Co. Ltd.

Upon receipt of marketing authorization in South Korea, Kuhnil will have the exclusive right and license to manufacture, distribute and sell KIT 302 in South Korea. Kuhnil will be responsible for seeking regulatory approval for KIT 302 in South Korea. Under the terms of the agreement, Kitov is entitled to receive milestone payments upon achievement of certain predefined regulatory milestones, as well as double digit royalties on net sales. The initial term of the definitive agreement with Kuhnil is for ten years from the date of first commercial sale and shall automatically renew for an additional one-year term. Commercial launch in South Korea is estimated to take place in 2019.

Comment; KT 302 (celecoxib + amlodipine)) in a Phase III, double-blind, placebo-controlled clinical trial successfully met the primary efficacy endpoint of the trial for pain relief in osteoarthritis, with hypertension reduction.

Comment:Kitov is subject to an Israeli Securities Authority investigation into the Data Monitoring Committee appointed in connexion with its Phase III trial. Kitov is continuing with the process of completing the preparations for submitting a New Drug Application for KIT 302, which was developed to simultaneously treat pain caused by osteoarthritis and hypertension, and which is still expected to be submitted to the FDA at the end of the first quarter 2017.