Kitov Receives Notice of Allowance for Additional U.S. Patent Covering its Commercial Product Consensi™
10 Maggio 2019 - 3:20PM
Kitov Pharma Ltd. (“Kitov”) (NASDAQ/TASE: KTOV), a pharmaceutical
company focused on advancing first-in-class combination oncology
therapies to overcome tumor drug resistance, increase treatment
response rate, and slow tumor progression, today announced that it
has received a notice of allowance from the U.S. Patent and
Trademark Office for its Patent Application 16/008,538, “Celecoxib
and Amlodipine formulation and methods of making the same,”
covering the proprietary formulation of Consensi™, Kitov’s
commercial-stage product for the simultaneous treatment of
osteoarthritis pain and hypertension. The patent application was
filed jointly with Dexcel Pharma Ltd., Kitov’s manufacturing
partner for Consensi™, which has provided Kitov with perpetual,
royalty-free, license rights for the use of the patent in
connection with distribution of Consensi™ in the U.S.
“We are pleased with this development. The new patent will
further strengthen Kitov's proprietary position and long-term
market exclusivity for Consensi™ in the U.S., together with the
existing Orange Book listed patent. We look forward to the
commercial launch in the U.S. by our commercialization partner,
Coeptis Pharmaceuticals, which is planned for the fourth quarter of
2019.” stated Kitov CEO, Isaac Israel.
David Mehalick, Co-founder & Executive Vice President of
Coeptis, said, “Consensi™ will substantially improve treatment for
patients living with two highly prevalent chronic conditions,
delivering improved clinical outcomes and enhanced economics for
healthcare providers. We expect to have it widely available soon to
the millions of Americans who can benefit from this combination
treatment.”
About Kitov Pharma
Kitov Pharma (Kitov Pharma Ltd.; NASDAQ/TASE: KTOV) is an
innovative pharmaceutical drug development company. Leveraging deep
regulatory and clinical trial expertise, Kitov’s veteran team of
healthcare and business professionals maintains a proven track
record in streamlined end-to-end drug development and approval.
Kitov’s combination drug, Consensi™, treating osteoarthritis pain
and hypertension simultaneously, was approved by the FDA for
marketing in the U.S and is partnered in the U.S, China and South
Korea. In addition, Kitov’s NT219, is a novel patented small
molecule designed to overcome cancer drug resistance that is
currently in pre-clinical development. Kitov is under contract to
acquire 100% of FameWave Ltd. which owns CM-24, a humanized
monoclonal antibody directed against carcinoembryonic
antigen-related cell adhesion molecule 1 (CEACAM1), an immune
checkpoint protein belonging to the Human CEA (Carcino-Embryonic
Antigen) protein family. CM-24 is being developed for multiple
oncological indications according to the expression pattern of its
target protein. Following the recent 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 their planned Phase 1/2
clinical trials to evaluate the combination of CM-24 with nivolumab
(Opdivo®), a PD-1 inhibitor, the acquisition is expected to close
during the third quarter of 2019, subject to fulfillment of certain
additional closing conditions.
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.
Forward-Looking 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 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; the
uncertainty surrounding an investigation by the Israel Securities
Authority into our historical public disclosures and the potential
impact of such investigation on the trading of our securities or on
our clinical, commercial and other business relationships, or on
receiving the regulatory approvals necessary in order to
commercialize our products, 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. For further
information, contact: Gil Efron Deputy CEO & Chief
Financial Officer +972-3-933-3121 ext. #105
IR@kitovpharma.com
Media Inquiries: Darren Opland, Ph.D.
darren@lifescipublicrelations.com +1 646 627 8387
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