Full Press Release Details
Kitov Reports KIT-302 Study
Successfully Meets U.S. Food & Drug Administration Bioequivalence Standards
plans to file New Drug Application with FDA this year for combination drug that simultaneously treats osteoarthritis pain and
May 10, 2016 - Kitov Pharmaceuticals (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company focused on late-stage
drug development, today announced that KIT-302 has successfully completed its pharmacokinetic (PK) bioequivalence (BE) study and
successfully met the U.S. Food and Drug Administration's (FDA) standards for establishing bioequivalence to the reference
the PK of Kitov's drug product of KIT-302 which is a fixed dose combination consisting of celecoxib (200 mg), indicated
for osteoarthritis pain, and amlodipine (10 mg), indicated for high blood pressure, to off-the-shelf branded 200 mg celecoxib
capsules and 10 mg amlodipine tablets. These evaluations were conducted under both fed and fasted conditions. The results demonstrated
that for both the Cmax (the maximum blood level achieved) and Area Under the Curve (the area under the concentration time curve
for drug levels), the 90% confidence intervals for both the amlodipine and celecoxib components of KIT-302 were documented to
be between 80% and 125% of the values obtained with the off-the-shelf drugs. These results mean Kitov has fulfilled the FDA standard
for demonstrating BE under both fed and fasted conditions.
"We are pleased to complete
our pharmacokinetic BE study on schedule this quarter. These results bring us one step closer towards submitting our New Drug
Application to the FDA for KIT-302 at the end of this year and the anticipated marketing approval in 2017," stated Dr. J.
Paul Waymack, Chairman of Kitov's Board and Chief Medical Officer.
requirements, a similar PK bioequivalence study for the KIT-302 product, containing a lower dosage (2.5 mg) of amlodipine will
be conducted by the end of this year. The FDA has indicated that KIT-302's final approval will not be dependent on this
Kitov Pharmaceuticals
Kitov 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, visit 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; or changes in the global pharmaceutical industry. . 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, which is available on the SEC's website, www.sec.gov.