Kitov Successfully Completes All KIT-302 Testing Required for New Drug Application to U.S. FDA - KIT-302 successfully completed 6 months stability testing required for the submission of a New Drug Application - NDA to be

Successfully Completes All KIT-302 Testing Required for New Drug Application to U.S. FDA

AVIV, Israel, December 7, 2016 /PRNewswire/ --Kitov Pharmaceuticals Holdings Ltd. (NASDAQ/TASE: KTOV), an innovative

biopharmaceutical company focused on late stage drug development, announced today that its lead drug candidate KIT-302 met the

U.S. Food and Drug Administration's (FDA) standards for establishing six months stability.

study, conducted by Kitov's manufacturing partner, Dexcel Pharma, demonstrated that nine pivotal batches of KIT-302, three

in each dosage forms (celecoxib/amlodipine of 200 mg/10 mg, 200 mg/5 mg, and 200 mg/2.5 mg) met the criteria demonstrating stability

for 6 months. The successful stability study enables registration batches of KIT-302 to be included in the New Drug Application

(NDA) submission which is planned during Q1 2017. The Certificate of Analysis demonstrated adequate stability required for submission,

in accordance with FDA guidelines. Kitov expects to submit additional stability data to the FDA at a later time, in order to extend

the labeled shelf life.

are very pleased with the stability study results, which we believe complete the testing required for our New Drug Application

to the FDA for KIT-302," stated Dr. J. Paul Waymack, Chairman of Kitov's Board and Chief Medical Officer.

is a fixed dose combination consisting of 200 mg of celecoxib, indicated for osteoarthritis pain, and 2.5, 5 or 10 mg of amlodipine,

indicated for high blood pressure. It is intended to treat pain caused by osteoarthritis (OA), as well as simultaneously treat

hypertension, which is a common side effect of certain stand-alone drugs that treat osteoarthritis pain, as well as a common concomitant

preexisting condition. KIT-302 is comprised of two U.S. Food and Drug Administration (FDA) approved drugs, celecoxib (the active

ingredient in Pfizer's Celebrex ), for the treatment of pain caused by osteoarthritis and amlodipine besylate (the

active ingredient in Pfizer's Norvasc ), a drug designed to treat hypertension. Kitov expects to submit a New Drug

Application for KIT-302, which successfully completed a pivotal Phase III trial, with the U.S. Food and Drug Administration during

a registered trademark of G.D. Searle LLC (a subsidiary of Pfizer Inc.). Norvasc is a registered

trademark of Pfizer Inc.

Kitov Pharmaceuticals

Pharmaceuticals (NASDAQ/TASE: KTOV) is an innovative biopharmaceutical company focused on late-stage drug development. 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 with the U.S. Food and Drug Administration is currently being prepared for submission. 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, 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 333-214820), 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

Kitov Pharmaceuticals Holdings Ltd.