Full Press Release Details
Announces License Agreement for KIT-302 in South Korea
agreement grants Kuhnil Pharmaceutical Co. Ltd. an exclusive license to manufacture and market KIT-302 in South Korea
is Kitov's First License Agreement for KIT-302
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.
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.
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
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."
Kitov Pharmaceuticals
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.
Kuhnil Pharmaceutical Co., Ltd.
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, license and commercializing medicines that address unmet medical
needs. http://www.kuhnil.com
Statements and Kitov's Safe Harbor Statement
statements in this press release are forward-looking statements within the meaning
of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other applicable securities
laws. Forward-looking statements can be identified by the use of forward-looking words such as "believe",
"expect", "intend", "plan", "may", "should", "could", "might",
"seek", "target", "will", "project", "forecast", "continue" or "anticipate"
or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly
to historical matters. You should not place undue reliance on these forward-looking statements, which are not guarantees of future
performance. Forward-looking statements reflect our current views, expectations, beliefs or intentions with
respect to future events, and are subject to a number of assumptions, involve known and unknown risks, many of which
are beyond our control, as well as uncertainties and other factors that may cause our actual results,
performance or achievements to be significantly different from any future results, performance or achievements
expressed or implied by the forward-looking statements. Important factors that could cause or
contribute to such differences include, among others, risks relating to: the fact that drug
development and commercialization involves a lengthy and expensive process with uncertain outcomes; our
ability to successfully develop and commercialize our pharmaceutical products; the expense, length,
progress and results of any clinical trials; the lack of sufficient funding to finance the clinical trials; the
impact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving
the regulatory approvals necessary in order to commercialize our products; the difficulty of predicting actions of the U.S.
Food and Drug Administration or any other applicable regulator of pharmaceutical products; the regulatory environment and changes
in the health policies and regimes in the countries in which we operate; the uncertainty surrounding the actual market reception
to our pharmaceutical products once cleared for marketing in a particular market; the introduction of competing products; patents
attained by competitors; dependence on the effectiveness of our patents and other protections for innovative products; our ability
to obtain, maintain and defend issued patents with protective claims; the commencement of any patent interference or infringement
action; our ability to prevail, obtain a favorable decision or recover damages in any such action; and the exposure to litigation,
including patent litigation, and/or regulatory actions; the uncertainty surrounding an investigation by the Israel Securities
Authority into our historical public disclosures and the potential impact of such investigation on the trading of our securities
or on our clinical, commercial and other business relationships, or on receiving the regulatory approvals necessary in order to
commercialize our products, and other factors that are discussed in our Registration
Statements on Form F-3 filed with the U.S. Securities and Exchange Commission (the "SEC") (file
numbers 333-211477, 333-207117, and 333-215037), in our Annual Report on Form 20-F for the year ended
December 31, 2015 and in our other filings with the SEC, including our cautionary
discussion of risks and uncertainties under "Risk Factors" in our Registration Statements and
Annual Reports. These are factors that we believe could cause our actual results to differ materially from expected
results. Other factors besides those we have listed could also adversely affect us. Any forward-looking statement
in this press release speaks only as of the date which it is made. We disclaim
any intention or obligation to publicly update or revise any forward-looking statement, or other information
contained herein, whether as a result of new information, future events or otherwise, except
as required by applicable law. You are advised, however, to consult any additional disclosures we make in our reports
to the SEC, which are available on the SEC's website, http://www.sec.gov.
Chief Financial Officer
+972-3-9333121 ext. #105
LifeSci Advisors, LLC