Definitive agreement grants Kuhnil Pharmaceutical Co. Ltd. an exclusive license to manufacture and market KIT-302 in South Korea
Transaction is Kitov’s First License Agreement for KIT-302
Celecoxib is the leading NSAID product in South Korea with reported sales of over $55 Million in 2015
TEL AVIV, Israel, March 8, 2017 - Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, announced today 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., a leading South Korea-based pharmaceutical company. 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.
Dr. Gil Ben-Menachem, Kitov’s Vice President of Business Development, said: “We are extremely pleased to enter into our first commercialization agreement for KIT-302 and look forward to building a long-term relationship with Kuhnil in South Korea and potentially to expanding the collaboration into other territories in the Far East. Kuhnil has a proven track record in successfully launching and marketing pharmaceutical products in South Korea, and is perfectly positioned to introduce KIT-302 into the Korean market. Kitov continues to work diligently towards executing additional commercialization agreements for KIT-302, in the US and other regions.”
“We believe that KIT-302 has significant commercial potential in South Korea and Asia,” said Young J. Kim, Kuhnil’s President & Chief Executive Officer. “Based on our decades of pharmaceutical development, regulatory and manufacturing experience and expertise in South Korea, we are well positioned to maximize the value of this product in the marketplace. We look forward to seeking regulatory approval and initiating launch preparations for KIT-302 in South Korea.”
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 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 for the U.S. Food and Drug Administration is currently being finalized, and is expected to be completed by the end of March 2017 and to be submitted to the FDA within two to three weeks thereafter. Kitov’s newest drug, NT219 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 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.
About Kuhnil Pharmaceutical Co., Ltd.
Kuhnil Pharmaceutical Co., Ltd. engages in the research and development, manufacture, and sale of pharmaceuticals products with strengths for the therapeutic areas of musculoskeletal, gastrointestinal, cardiovascular, respiratory, infection and neurology. The company is also specialized in research and development in the areas of advanced DDS and drug formulation, and combination drug development. Kuhnil focuses on improving quality of life by developing, licensing and commercializing medicines that address unmet medical needs. http://www.kuhnil.com
