Kitov Pharmaceuticals Hldgs L Sponsored ADR (KTOV)

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Kitov Pharma Provides Update on Planned U.S. Launch of Consensi(TM) and Provides Three-Year Revenue Forecast
8:15 AM ET 3/12/20 | GlobeNewswire
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Kitov Pharma Provides Update on Planned U.S. Launch of Consensi(TM) and Provides Three-Year Revenue Forecast

-- Company's marketing partners in the U.S. plan to commence selling

Consensi in May 2020

-- Kitov expects to receive between $28 million and $36 million in milestone

and royalty revenues from 2020 through 2022

TEL AVIV, Israel, March 12, 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 provided an update on the planned U.S. commercial launch of Consensi(TM), a fixed-dose combination of celecoxib, and amlodipine besylate, designed for the simultaneous treatment of osteoarthritis pain and hypertension, that was approved for marketing by the U.S. Food & Drug Administration. The Company's manufacturing partner is completing the packaging, release and shipment of Consensi(TM) to Kitov's marketing partners, that is expected to begin selling Consensi(TM) in the U.S. in May 2020.

According to the U.S. marketing and distribution agreements, Kitov is eligible to receive up to $99.5 million in milestone, reimbursement payments, and royalties. The Company expects to receive aggregate milestone and royalty revenues of between $28 million and $36 million from 2020 through 2022. The projected revenues will provide an important source of financial support for Kitov as the Company continues to advance its emerging oncology pipeline, including bringing both CM-24 and NT-219 into the clinic this year.

About Kitov Pharma

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. CM-24 is a monoclonal antibody blocking CEACAM1, a novel immune checkpoint that supports tumor immune evasion and survival through multiple pathways. Kitov intends to advance CM-24 as a combination therapy with anti-PD1 checkpoint inhibitors for the treatment of non-small cell lung cancer (NSCLC). Kitov has entered into a clinical collaboration agreement with Bristol Myers Squibb (NYSE:BMY) for the planned Phase 1/2 clinical trials to evaluate the combination of CM-24 with the PD-1 inhibitor nivolumab (Opdivo(R)). Kitov is also the owner of Consensi(TM), 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 is expected to be launched in the U.S. in May 2020. Kitov has also partnered to commercialize Consensi(TM) in China and South Korea. The company is headquartered in Tel Aviv, Israel. For more information, please visit http://www.kitovpharma.com.

About Consensi(TM)

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 and Kitov is partnered in the U.S, China and South Korea.

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

Important Safety Information (ISI) for Consensi(R)

WARNING: RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL

EVENTS

See full prescribing information for complete boxed warning.

CONSENSI contains celecoxib, a nonsteroidal anti-inflammatory

drug (NSAID), and amlodipine, a calcium channel blocker (CCB).

NSAIDs can cause serious side effects, including:

-- Increased risk of a heart attack or stroke that can

lead to death. This risk may happen early in

treatment and may increase with duration of use.

-- Do not take CONSENSI right before or after a heart

surgery called a "coronary artery bypass graft"

(CABG).

-- Avoid 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.

-- NSAID medications, like celecoxib, cause an increased

risk of bleeding, ulcers, and tears (perforation) of

the esophagus, stomach, and intestines, at any time

during treatment, which can occur without warning and

may cause death. Elderly patients and patients with a

prior history of peptic ulcer disease and/or GI

bleeding are at greater risk for serious GI events.

What is the most important information I should know about Consensi?

Consensi contains celecoxib, a nonsteroidal anti-inflammatory drug (NSAID), and amlodipine, a calcium channel blocker (CCB). NSAIDs can cause serious side effects, including:

-- Increased risk of a heart attack or stroke that can lead to death. This

risk may happen early in treatment and may increase:

-- with increasing doses of NSAIDs

-- with longer use of NSAIDs

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

Avoid 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.

-- Increased risk of bleeding, ulcers, and tears (perforation) of the

esophagus (tube leading from the mouth to the stomach), stomach, and

intestines:

-- anytime during use

-- without warning symptoms

-- that may cause death

The risk of getting an ulcer or bleeding increases with:



-- past 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)"

-- older age

-- increasing doses of NSAIDs

-- poor health

-- longer use of NSAIDs

-- smoking -- advanced liver disease

-- bleeding problems

-- drinking alcohol

You 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.

Consensi should only be used:

-- exactly as prescribed

-- at the lowest dose possible for your treatment

-- for the shortest time needed

Who should not take Consensi?

Do not take Consensi:

-- if you are allergic to amlodipine, celecoxib or any of the inactive

ingredients in Consensi.

-- if you have had an asthma attack, hives, or other allergic reaction with

aspirin or any other NSAIDs.

-- right before or after heart bypass surgery.

-- if you have had an allergic reaction to sulfonamides.

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

-- have heart problems.

-- have liver or kidney problems.

-- have asthma.

-- are pregnant or plan to become pregnant. Talk to your healthcare provider

if you are considering taking Consensi during pregnancy. You should not

take Consensi after 29 weeks of pregnancy.

-- are breastfeeding or plan to breastfeed. Consensi can pass into your

breast milk. It is not known if Consensi will harm your baby. Talk with

your healthcare provider about the best way to feed your baby if you take

Consensi.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Consensi(R) 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.

What are the possible side effects of Consensi?

Consensi can cause serious side effects, including:

-- liver problems, including liver failure

-- worsening chest pain (angina) or heart attack, particularly in people

with severe obstructive coronary artery disease

-- heart failure

-- swelling of your arms, legs, hands and feet (peripheral edema) is common

with Consensi but can sometimes be serious.

-- kidney problems, including kidney failure

-- increased potassium levels (hyperkalemia)

-- life-threatening allergic reactions

-- life-threatening skin reactions

-- low red blood cells (anemia)

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

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

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.

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March 12, 2020 08:15 ET (12:15 GMT)