Kitov Announces U.S. Commercial Launch of Consensi

Announces U.S. Commercial Launch of Consensi

AVIV, Israel, May 20, 2020 (GLOBE NEWSWIRE) -- Kitov Pharma Ltd. ("Kitov") (NASDAQ/TASE: KTOV), a clinical-stage company

advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, today announced the U.S. commercial launch

of Consensi , a fixed-dose combination of celecoxib and amlodipine besylate, designed for the simultaneous treatment of

hypertension and osteoarthritis pain. Consensi is being sold in the U.S. by Burke Therapeutics, the marketing partner of

Kitov's U.S. distributor, Coeptis Pharmaceuticals.

provides a new therapeutic option for patients suffering from both hypertension and osteoarthritis-related pain. We are excited

about the availability of Consensi for patients", said Dave Mehalick, Chief Executive Officer of Coeptis Pharmaceuticals.

are pleased Consensi is now available and our sales team is eager to introduce this one tablet, once a day treatment for

hypertension and osteoarthritis pain to the U.S. market", said Angela Sutterer, Chief Executive Officer of Burke Therapeutics.

initial U.S. sales of Consensi represents a key milestone for Kitov," said Isaac Israel, Chief Executive Officer

of Kitov. "We are confident that Coeptis' and Burke's extensive distribution reach will enable us to

maximize Consensi 's market potential. The projected royalties and milestone revenues from our U.S.

marketing and distribution agreements for Consensi , together with the $26 million gross fundraising

proceeds we secured this year, will provide the source of financial support for our development efforts aimed at advancing

our emerging oncology pipeline, including advancing both NT-219 and CM-24 into significant value creating clinical

milestones. We look forward to providing further updates about Consensi 's marketing activities and progress

Kitov Pharma (Kitov Pharma Ltd.; NASDAQ/TASE: KTOV) is a clinical-stage company focusing on advancing first-in-class

therapies to overcome tumor immune evasion and drug resistance, to create successful long-lasting treatments for people with cancer.

Kitov's oncology pipeline includes NT-219 and CM-24. NT-219 is a small molecule targeting the novel cancer drug resistance

pathways IRS1/2 and STAT3. Kitov is currently advancing NT-219 in combination with cetuximab as a third-line or second-line treatment

option for the treatment of recurrent and metastatic squamous cell carcinoma of head & neck cancer (SCCHN), as well as a single

agent monotherapy treatment in patients with advanced solid tumors in a planned phase 1/2 study. CM-24 is a monoclonal antibody

blocking CEACAM1, a novel immune checkpoint that supports tumor immune evasion and survival through multiple pathways. Kitov plans

to advance CM-24 as a combination therapy with anti-PD1 checkpoint inhibitors in selected cancer indications in a phase 1 study

followed by a phase 2 for the treatment of non-small cell lung cancer NSCLC and pancreatic cancer. Kitov has entered into a clinical

collaboration agreement with Bristol Myers Squibb Company for the planned phase 1/2 clinical trials to evaluate the combination

of CM-24 with the PD-1 inhibitor nivolumab (Opdivo ). Kitov is also the owner of Consensi , a fixed-dose combination

of celecoxib and amlodipine besylate, for the simultaneous treatment of osteoarthritis pain and hypertension which was approved

by the FDA for marketing in the U.S in May 2018 and was launched in the U.S. in May 2020 by its partner Coeptis Pharmaceuticals

in the U.S.. Kitov has also partnered to commercialize Consensi in China and South Korea. The company is headquartered in Tel

Aviv, Israel. For more information, please visit http://www.kitovpharma.com.

Consensi is a fixed-dose combination of amlodipine besylate, a calcium channel blocker for the treatment of

hypertension, to lower blood pressure, and celecoxib, a nonsteroidal anti-inflammatory drug (NSAID) for the management of the

signs and symptoms of osteoarthritis. The U.S. Food & Drug Administration (FDA) approved Consensi oral tablets for

marketing in the U.S..

additional information see DailyMed, Full Prescribing Information, including BOXED WARNING and Medication Guide.

Safety Information (ISI) for Consensi

is the most important information I should know about Consensi?

celecoxib, a nonsteroidal anti-inflammatory drug (NSAID), and amlodipine, a calcium channel blocker (CCB). NSAIDs can cause serious

side effects, including:

not take Consensi right before or after a heart surgery called a "coronary artery bypass graft" (CABG).

taking Consensi after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another

heart attack if you take NSAIDs after a recent heart attack.

risk of getting an ulcer or bleeding increases with:

history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs taking medicines called "corticosteroids",

"antiplatelet drugs", "anticoagulants", "selective serotonin reuptake inhibitors (SSRIs)",

or "serotonin norepinephrine reuptake inhibitors (SNRIs)"

should not take other medicines that contain NSAIDs or salicylates during treatment with Consensi because of increased risk of

stomach problems. Taking other medicines that contain NSAIDs or salicylates during treatment with Consensi will not provide increased

relief of symptoms of osteoarthritis.

should only be used:

should not take Consensi?

taking Consensi, tell your healthcare provider about all your medical conditions, including if you:

your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or

herbal supplements. Consensi and some other medicines can interact with each other and cause serious side effects. Do

not start taking any new medicine without talking to your healthcare provider first.

are the possible side effects of Consensi?

can cause serious side effects, including:

"What is the most important information I should know about Consensi?" for further detail regarding serious side effects.

healthcare provider will monitor your blood pressure and do blood tests to check you for side effects during treatment with Consensi.

may cause fertility problems in females that is reversible when treatment with Consensi is stopped. Talk to your healthcare provider

if this is a concern for you.

most common side effects of Consensi include:

emergency help right away if you get any of the following symptoms:

taking Consensi and call your healthcare provider right away if you get any of the following symptoms:

are not all the possible side effects of Consensi.

your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

You may also report side effects to Burke Therapeutics, LLC at 1-866-275-1264.

see Full Prescribing Information, including BOXED WARNING, and Medication Guide.

Statements and Kitov's Safe Harbor Statement

statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements

within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking

statements include, but are not limited to, statements that are not statements of historical fact, and may be identified by 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: different results from the expected benefits and synergies of the acquisition of FameWave by

Kitov; management plans relating to the transaction; the plans, strategies and objectives of management for future operations;

product development for NT219 and CM-24; the potential future financial impact of the transaction; and any assumptions underlying

any of the foregoing; the process by which early stage therapeutic candidates such as NT219 and CM-24 could potentially lead to

an approved drug product is long and subject to highly significant risks, particularly with respect to a joint development collaboration;

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,