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 in the U.S:
- Marketing and distribution agreement with Coeptis
Pharmaceuticals for commercialization of ConsensiTM in the U.S has
been amended. Kitov will receive up to $99.5M in milestone and
reimbursement payments plus 20% in royalties, with a minimum
aggregate of $7 million in the next 3 years.
- Coeptis has engaged a distribution partner with an established
sales network and access to thousands of pharmacies to drive the
launch of the drug. In addition, a marketing plan and pricing
strategy have been finalized.
- Manufacturing of the initial commercial batches is now in its
latest phases and will soon be ready for packaging and shipping to
the U.S.
“As 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.”
"Our 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."
Under 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.
About Consensi™
ConsensiTM is 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.
Full US Prescribing Information, including BOXED
WARNING and Medication Guide is available
at: www.consensi.com.
Indications and Usage:
Consensi™ 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.
Limitations of Use:Consensi™ is only available in a celecoxib
strength of 200 mg and is only to be taken once daily.
Important Safety Information (ISI) for
Consensi™
The 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™.
Nonsteroidal 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.
Consensi™ is contraindicated in the
setting of coronary artery bypass graft (CABG)
surgery.
NSAIDs 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.
Consensi™ is contraindicated in patients with a
known hypersensitivity to amlodipine, celecoxib or any of its
inactive ingredients.
Consensi™ 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.
Consensi™ is contraindicated in patients with
known demonstrated allergic-type reactions to sulfonamides.
Significant warnings and precautions related to
Consensi™ include the following:
Patients 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.
Patients taking some antihypertensive
medications may have impaired response to these therapies when
taking NSAIDs. Physicians should carefully monitor blood
pressure.
Symptomatic hypotension is possible,
particularly in patients with severe aortic stenosis.
Worsening angina and acute myocardial
infarction, particularly in patients with severe obstructive
coronary artery disease, is possible.
Physicians should avoid use of Consensi™ in
patients with severe heart failure.
Physicians 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.
Patients should seek emergency help if an
anaphylactic reaction occurs.
Consensi™ is contraindicated in patients with
aspirin-sensitive asthma. Monitor patients with preexisting asthma
(without aspirin sensitivity).
Physicians should discontinue Consensi™ at the
first appearance of skin rash or other signs of
hypersensitivity.
NSAIDs such as Consensi™ can cause premature
Closure of Fetal Ductus Arteriosus.
Avoid use in pregnant women starting at 30 weeks
of gestation.
Physicians should monitor hemoglobin or
hematocrit in patients with any signs or symptoms of anemia.
Consensi™ is not recommended in patients with
moderate or severe hepatic impairment or severe renal
insufficiency.
Consensi™ is not recommended in Poor
Metabolizers of CYP2C9 Substrates. To
report SUSPECTED ADVERSE REACTIONS, contact Coeptis Pharmaceuticals
at 1-800-651-6606 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch
About Coeptis
PharmaceuticalsCoeptis 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.
About Kitov PharmaKitov 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.
Forward-Looking Statements and Kitov's
Safe Harbor StatementCertain 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: 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; the parties’
ability to complete the transaction considering the various closing
conditions; 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 products such as CM-24 could potentially lead to
an approved 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,
and other factors that are discussed in our in our Annual Report on
Form 20-F for the year ended December 31, 2018 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
Investor Contact Gil Efron Deputy & Chief
Financial Officer IR@kitovpharma.com +972-3-933-3121
ext. #105
Media Contact: Gloria Gasaatura
ggasaatura@lifescipublicrelations.com +1 646 627 8387
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