Full Press Release Details
Pharma Announces Amended Marketing and Distribution Agreement with Coeptis and Provides Update on the Upcoming Launch of ConsensiTM
AVIV, Israel, Oct. 11, 2019 (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 amendment
of the marketing and distribution agreement with Coeptis Pharmaceuticals and provided an update on the upcoming launch of Consensi
we get closer to the launch of ConsensiTM in the U.S., we are excited about Coeptis' commercialization strategy
and welcome Coeptis' new partners who have an established distribution and operations infrastructure. We believe that their
expertise and immense network will boost sales and will establish ConsensiTM as an ideal therapeutic option for
patients suffering from both osteoarthritis related pain and hypertension," said Isaac Israel, chief executive officer of
Kitov. "In addition, the terms of the amended agreement create near-term revenue streams to support further development
of our oncology pipeline - a key focus for Kitov."
agreement with Kitov is mutually beneficial and the updated agreement is another solid example of the strong collaboration between
Coeptis and Kitov. We look forward to continuing our close relationship with Kitov, especially as we gear up to launch ConsensiTM in
the US," said Modi Obochi, president and chief executive officer of Coeptis. "The recent selection of a distribution
partner for ConsensiTM illustrates our strong commitment to meet our business objectives and to provide therapeutic
options to the patients. We look forward to leveraging the cash flow from ConsensiTM to advance our portfolio."
the terms of the amended agreement Kitov will receive 20% in royalties on net sales of ConsensiTM with minimum
royalties of $4.5M over the next 3 years. In addition, Kitov is entitled to receive up to $99.5M in milestone and reimbursement
payments, of which $1M was previously received, $1.5M is expected before the end of the year in connection with the manufacturing
of the initial commercial batches, an additional $1M is due following the first commercial sale of ConsensiTM in
the U.S. and $96M which is subject to certain pre-defined commercial milestones.
a fixed-dose combination of celecoxib, a non-steroidal anti-inflammatory drug (NSAID) for the treatment of pain caused by osteoarthritis,
and amlodipine besylate, a drug designed to treat hypertension. The U.S. Food & Drug Administration (FDA) approved ConsensiTM oral
tablets for marketing on May 2018 and partnered in the U.S, China and South Korea. ConsensiTM is under patent
protection in the U.S. until 2030 and will be the only NSAID whose labeling indicates a reduction of blood pressure and consequent
risk reduction of heart attack, stroke and death.
US Prescribing Information, including BOXED WARNING and Medication Guide is available at: www.consensi.com.
is a combination of amlodipine besylate, a calcium channel blocker, and celecoxib, a nonsteroidal anti-inflammatory drug (NSAID),
indicated for patients for whom treatment with amlodipine for hypertension and celecoxib for osteoarthritis are appropriate. Lowering
blood pressure reduces the risk of fatal and nonfatal CV events, primarily strokes and myocardial infarctions.
Consensi is only available in a celecoxib strength of 200 mg and is only to be taken once daily.
Safety Information (ISI) for Consensi
following ISI is based on the Highlights section of the U.S. Prescribing Information for Consensi . Please consult the full
Prescribing Information for all of the labelled safety information for Consensi .
anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial
infarction and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use.
contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
cause an increased risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration and perforation of the
stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly
patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
is contraindicated in patients with a known hypersensitivity to amlodipine, celecoxib or any of its inactive ingredients.
is contraindicated in patients with a known history of asthma, urticaria or other allergic-type reactions after taking aspirin
or other NSAIDs and in the setting of CABG surgery.
is contraindicated in patients with known demonstrated allergic-type reactions to sulfonamides.
warnings and precautions related to Consensi include the following:
should be warned about the potential signs and symptoms of hepatotoxicity and hepatic failure. Physicians should discontinue
Consensi if abnormal liver tests persist or worsen, or if clinical signs and symptoms of liver disease develop.
taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Physicians should carefully
monitor blood pressure.
hypotension is possible, particularly in patients with severe aortic stenosis.
angina and acute myocardial infarction, particularly in patients with severe obstructive coronary artery disease, is possible.
should avoid use of Consensi in patients with severe heart failure.
should monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia, and avoid
the use of Consensi in patients with advanced renal disease.
should seek emergency help if an anaphylactic reaction occurs.
is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).
should discontinue Consensi at the first appearance of skin rash or other signs of hypersensitivity.
such as Consensi can cause premature Closure of Fetal Ductus Arteriosus.
use in pregnant women starting at 30 weeks of gestation.
should monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
is not recommended in patients with moderate or severe hepatic impairment or severe renal insufficiency.
is not recommended in Poor Metabolizers of CYP2C9 Substrates.
report SUSPECTED ADVERSE REACTIONS, contact Coeptis Pharmaceuticals at 1-800-651-6606 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Coeptis Pharmaceuticals, Inc. is a privately held biopharmaceutical company engaged in the acquisition, development and commercialization
of innovative products that utilizes the 505(b)2 pathways. Coeptis licensed FDA-approved Consensi (a combination of amlodipine
and celecoxib), which is indicated for patients for whom treatment with amlodipine for hypertension and celecoxib for osteoarthritis
are appropriate. It is in the process of launching ConsensiTM in the US through a distribution partner with an
established sales network to thousands of pharmacies nationwide. Headquartered near Pittsburgh, PA, Coeptis has put together seasoned
pharmaceutical executives with demonstrated successes growing revenues and shareholder value and has a robust pipeline of 505(b)2
products at various stages of development. For more information, please visit www.coeptispharma.com.
Kitov Pharma (Kitov Pharma Ltd.; NASDAQ/TASE: KTOV) is a clinical-stage company 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, 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). Kitov is also under contract to acquire
100% of FameWave Ltd. which owns CM-24, a monoclonal antibody blocking CEACAM1, a novel immune checkpoint that supports tumor
immune evasion and survival through multiple pathways. Kitov will advance CM-24 as a combination therapy with anti-PD1 checkpoint
inhibitors for the treatment of non-small cell lung cancer (NSCLC). Following the receipt of the approval of Kitov's shareholders
for the acquisition of FameWave, and the finalization of a clinical collaboration agreement between FameWave and 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 ), the acquisition is expected to close during 2019, subject to fulfillment of certain additional closing conditions.
Consensi, a fixed-dose combination of celecoxib and amlodipine besylate, for the simultaneous treatment of osteoarthritis pain
and hypertension was approved by the FDA for marketing in the U.S in May 2018 and is expected to be launched in the U.S. by early
2020 by its partner Coeptis Pharmaceuticals. 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.
Statements and Kitov's Safe Harbor Statement
Certain 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
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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 manner in which the parties to
the transaction for the acquisition of FameWave by Kitov plan to effect the transaction; the expected benefits, synergies and
costs of the transaction; management plans relating to the transaction; the expected timing of the completion of the transaction;