Full Press Release Details
Pharmaceuticals Publishes Annual Report for 2017
and Issues CEO Letter to Shareholders
Aviv, Israel, March 5, 2018 - Kitov Pharmaceuticals (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company,
announced today that it filed its Annual Report for 2017 on Form 20-F, including its full financial results for the year ended
also today released a Letter from Chief Executive Officer, Isaac Israel, regarding recent activities and plans:
the publication of our Annual Report for 2017, I would like to share with you our major accomplishments during 2017 and our plans
and expectations for 2018.
team made important progress on our lead drug candidate, Consensi (which we formerly referred to as KIT-302).
a combination drug that simultaneously treats pain caused by osteoarthritis and treats hypertension, is comprised of two FDA approved
drugs, celecoxib (Celebrex ), an NSAID, for the treatment of pain caused by osteoarthritis, and amlodipine besylate (Norvasc ),
a drug designed to treat hypertension. Hypertension is one of the side effects of using non-steroidal anti-inflammatory drugs,
or NSAIDs, including celecoxib. Approximately 50% of the patients suffering from osteoarthritis in the US also suffer from hypertension,
so industry sources estimate there are millions of patients that suffer from both conditions.
made advances in several important areas:
The FDA filed our New Drug Application (NDA) for Consensi , following our submission of the NDA. We
are very proud of the high-quality NDA package that was filed by the FDA. The FDA has set a PDUFA date of May 31,
Clinical Trial Results: We announced the top-line results of our Phase III/IV randomized double-blind, placebo-controlled
renal function clinical trial for Consensi . These results successfully validated the primary efficacy endpoint of our earlier
successfully completed Phase III clinical trial. As such, we now have additional clinical evidence that establishes that adding
celecoxib to amlodipine does not impair the blood pressure lowering effects of amlodipine. The trial also increased the total
number of patients treated with Consensi , which we believe could increase the probability of ultimately receiving marketing
approval for Consensi from the FDA.
the Phase III/IV study strengthened the clinical evidence of the positive effect of Consensi on kidney function, which
could provide us with a significant marketing advantage in the future.
importantly, we have advanced towards our goal of providing a safer NSAID, with the potential to be the first and only NSAID in
the market which is both effective in lowering blood pressure and reduces the risk of kidney damage.
Partnership: We signed a definitive License Agreement for Consensi with Kuhnil Pharmaceutical Co. Ltd., a leading
South Korean pharmaceutical company, for the territory of South Korea. Kuhnil will bear responsibility for and the costs of seeking
regulatory approval for Consensi in South Korea. Under the terms of the agreement, we are entitled to receive payments
upon achievement of certain predefined regulatory milestones, as well as double-digit royalties on net sales. Our relationship
with Kuhnil and preparations for commercial launch in South Korea are proceeding as planned, and we have received our first milestone
payment from Kuhnil.
Korea is an important, attractive, gateway market into Asia, and we are very pleased with our choice of Kuhnil, which has the
organizational and marketing infrastructure and capabilities for a successful commercial launch, which is expected to occur in
Protection: We received a Notice of Allowance from the U.S. Patent & Trademark Office (USPTO) related to claims expanding
the patent coverage of Consensi to include oral dosage compositions containing both amlodipine and celecoxib. The
Notice of Allowance should result in the issuance of an additional patent that would further strengthen Kitov's proprietary position
and long-term U.S. market exclusivity for Consensi .
NT219 - Small molecule oncology drug
acquired a majority stake in TyrNovo, a private oncology company, which is developing NT219, a small molecule drug that presents
a new and exciting concept in cancer therapy by attempting to address a major problem whose solution has been elusive to date
- tumors' developing cancer-drug resistance. NT219 is a unique compound that is designed to prevent and reverse resistance
to anti-cancer drugs through dual inhibition of STAT3 and IRS1/2, two signal pathways associated with drug resistance. Kitov's
current ownership in TyrNovo is 65% and we have a pending transaction to increase our stake in TyrNovo to approximately 92%, expected
to be closed in the next few weeks.
are very pleased with this acquisition, its progress during 2017 and, most importantly, its long-term potential. NT219 has demonstrated
impressive efficacy in large array of pre-clinical models with several leading targeted oncology drugs, with chemotherapy drugs
and with Immuno-Oncology drugs in various cancer types, including in combination with Keytruda . Our development program is
of critical importance, as we prepare for the start of human clinical trials in 2019.
we received the FDA's response to NT219's pre-IND meeting package. In its response, the FDA agreed to our preclinical
and clinical development plans for NT219, and we are considering the initiation of clinical studies in combination with gemcitabine
(Gemzar ) for the treatment of pancreatic cancer and/or in combination with osimertinib (TagrissoTM) for the
treatment of non-small cell lung cancer (NSCLC).
goal is to develop NT219 in combination with approved oncology drugs to increase efficacy, expand target populations and treatment
duration. Our long-term strategy is to develop NT219 in combination with other oncology drugs and for additional oncology indications,
on our own or in collaboration with potential strategic partners. Our preliminary partnering discussions for NT219 have yielded
positive feedback, and this will be a focus area for TyrNovo throughout 2018.
major goals for 2018 are:
want to thank you, our shareholders, for the trust you have placed in us. Our board of directors and management team is committed
to continuing to unlock the substantial value in our business by leveraging our team's deep regulatory expertise and drug
development experience, complemented by targeted business development efforts, in order to maximize the potential of our therapeutic
past year has taught us all at Kitov a great deal about our team's special human qualities and its determination, dedication,
and commitment to face any challenge.
look forward to providing you with further updates on our continued progress throughout 2018.
wishes for a successful year.
Chief Executive Officer"
Kitov Pharmaceuticals
Pharmaceuticals (Kitov Pharma Ltd.; NASDAQ/TASE: KTOV) is an innovative biopharmaceutical drug development group of companies.
Leveraging deep regulatory and clinical-trial expertise, Kitov's veteran team of healthcare and business professionals maintains
a proven track record in streamlined end-to-end drug development and approval. Kitov's flagship combination drug, Consensi
(the branded name for KIT-302), intended to treat osteoarthritis pain and hypertension simultaneously, achieved the primary efficacy
endpoints for its Phase III and Phase III/IV clinical trials. Kitov's NT219, which is developed by its majority-owned subsidiary
TyrNovo Ltd., is a novel patented small molecule designed to overcome cancer drug resistance that is currently in pre-clinical
development. 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.
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