Full Press Release Details
Announces Issuance of U.S. Patent
Long-Term Exclusivity for KIT-302 Ahead of New Drug Application to the FDA
Israel August 10, 2016 -- Kitov Pharmaceuticals (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company focused on late-stage
drug development, today announced that the United States Patent and Trademark Office (USPTO) issued patent #9,408,837 covering
Kitov's lead drug candidate KIT-302 which the Company expects to submit for a New Drug Application to the U.S. Food and
Drug Administration by the end of 2016.
patent, entitled "Ameliorating Drug-Induced Elevations In Blood Pressure By Adjunctive Use Of Antihypertensive Drugs,"
was issued on August 9, 2016 and will have a term that can extend to May 22, 2029. Kitov Pharmaceuticals is pursuing additional
claims to inventions described in the U.S. Patent #9,408,837.
simultaneously treats pain caused by osteoarthritis and treats hypertension, which is a common side effect of certain stand-alone
drugs that treat osteoarthritis pain. KIT-302 is comprised of two U.S. FDA approved drugs, celecoxib (the active ingredient in
Pfizer's Celebrex ), for the treatment of pain caused by osteoarthritis and amlodipine besylate, a drug designed to
are pleased with this newly granted patent for claims in connection with our KIT-302, representing a significant achievement for
Kitov's combination drug developments," said J. Paul Waymack, MD the Chairman of the Board of Directors and Chief
Medical Officer of Kitov. "We are committed to further developing the patent holdings over our proprietary assets in order
to maximize value to our shareholders."
Kitov Pharmaceuticals
Pharmaceuticals (NASDAQ/TASE: KTOV) is an innovative biopharmaceutical company focused on late-stage drug development. Leveraging
deep regulatory and clinical-trial expertise, Kitov's veteran team of healthcare professionals maintains a proven track record
in streamlined end-to-end drug development and approval. Kitov's pipeline currently features two combination drugs intended to
treat osteoarthritis pain and hypertension simultaneously, including one that achieved the primary efficacy endpoint for its Phase
III clinical trial. Lowering development risk and cost through fast-track regulatory approval of novel late-stage therapeutics,
Kitov delivers rapid ROI and long-term potential to investors, while making a meaningful impact on people's lives. For more information,
the content of which is not part of this press release, visithttp://www.kitovpharma.com
press release contains forward-looking statements about the Company's expectations, beliefs and intentions. Forward-looking statements
can be identified by the use of forward-looking 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. These
forward-looking statements involve certain risks and uncertainties, including, among others, the risk that drug development involves
a lengthy and expensive process with uncertain outcome; the Company's ability to successfully develop and commercialize its pharmaceutical
product; the length, progress and results of any clinical trials; the introduction of competing products; the impact of any changes
in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals
to commercialize the Company's products; the lack of sufficient funding to finance the clinical trials; the difficulty of predicting
actions of the USA FDA; the regulatory environment and changes in the health policies and regimes in the countries in
which we operate; changes in the global pharmaceutical industry; patents attained by competitors; dependence on the effectiveness
of the Company's patents and other protections for innovative products; the Company's ability to obtain, maintain and defend issued
patents with protective claims; the issuance and term of patents; the commencement of any patent interference or infringement
action; the Company's ability to prevail in or obtain a favorable decision in any such action; the Company's ability to recover
damages in any such action; and the exposure to litigation, including patent litigation, and/or regulatory actions. Any
forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation
to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise,
except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting
the Company is contained under the heading "Risk Factors" in Kitov Pharmaceuticals Holdings Ltd.'s Registration Statement
on Form F-1 filed with the SEC (file number 333-211477), which is available on the SEC's website, http://www.sec.gov.
Chief Financial Officer