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Kitov Announces Consensi as Brand Name for KIT-302

Key Takeaway: Announces Consensi as Brand Name for KIT-302 Israel, December 14, 2017 /PRNewswire/ -- Kitov Pharmaceuticals (NASDAQ: KTOV) (TASE: KTOV), an innovative biopharmaceutical company, announced today that the U.S. Food & Drug Administration (FDA) has granted permission to Kitov to

Full Press Release Details

Announces Consensi as Brand Name for KIT-302
Israel, December 14, 2017 /PRNewswire/ --
Kitov Pharmaceuticals
(NASDAQ: KTOV) (TASE: KTOV), an innovative biopharmaceutical company, announced today that the U.S. Food & Drug Administration
(FDA) has granted permission to Kitov to use the brand name Consensi for marketing KIT-302, subject to receipt of marketing
approval from the FDA.
receipt of the FDA's permission to use Consensi as the brand name for our lead drug is another important step in executing on
our corporate strategy and will facilitate the commercialization of KIT-302, once approved by the FDA, " stated J. Paul Waymack,
M.D., Sc.D., Kitov's Chairman of the Board and Chief Medical Officer.
a combination drug that is intended to simultaneously treat pain caused by osteoarthritis, as well as hypertension, which is a
common side effect of stand-alone drugs that treat osteoarthritis pain. Consensi is comprised of two FDA approved
drugs, celecoxib (Celebrex ), a COX-2 inhibitor, for the treatment of pain caused by osteoarthritis, and amlodipine
besylate (Norvasc ), a calcium channel blocker for lowering blood pressure.
2017, the FDA filed Kitov's New Drug Application (NDA) for Consensi and, under the Prescription Drug User Fee Act (PDUFA),
set a target date of May 31, 2018 to complete its review.
Kitov Pharmaceuticals
Kitov Pharmaceuticals
(NASDAQ: KTOV, 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, Consensi (previously referred to as 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 newest drug, NT219, which is developed by its majority-owned subsidiary, TyrNovo Ltd., 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 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.
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statements in this press release are forward-looking statements within the meaning of the safe harbor provisions of the Private
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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 in our Annual Report on Form 20-F for the year ended December 31, 2016 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
+972-3-9333-121 ext. #105
LifeSci Advisors, LLC
Last updated: Dec 14, 2017