JERUSALEM, Dec. 6, 2018 /PRNewswire/ -- Intec Pharma Ltd.
(NASDAQ: NTEC) ("Intec" or "the Company") today announces that the
Accordion Pill™ developed for a proprietary Novartis compound is
continuing into a clinical PK study under the previously announced
Feasibility and Option agreement with Novartis Pharmaceuticals.
Following achievement of the required in-vitro
specifications, the companies are continuing the program into a
clinical PK study during the first half of 2019. The details
of the therapeutic area or specific compound were not released.
"During 2018, our Intec team developed an Accordion Pill for
Novartis' proprietary compound that meets the required in
vitro specifications set forth in the feasibility
agreement. Novartis and Intec have mutually agreed to proceed
with the program and we plan to enter the clinic in the first half
of 2019. Novartis and Intec are excited to conduct these
studies to collect critical information to determine the program's
clinical and commercial potential," stated Nadav Navon, Ph.D., Chief Operating Officer of
Intec Pharma.
"We are delighted to be continuing this collaboration with
Novartis in the coming year. We have met the technological
challenge of developing a custom-designed Accordion Pill for this
proprietary compound, and look forward to proceeding with this
study," said Jeffrey A. Meckler,
Vice Chairman and Chief Executive Officer of Intec Pharma. "Our
unique Accordion Pill gastric retention platform offers an
opportunity to enhance the characteristics of proprietary compounds
and develop innovative approaches to the treatment of a variety of
diseases. Moving forward, we look to leverage this novel platform
and to expand the number of collaborations with drug development
companies."
About Accordion Pill Technology
The Accordion Pill is
a drug delivery system that uses biodegradable polymeric films,
which combine and load drugs and inactive ingredients onto these
films, folds them into an undulated shape and then places them
inside a capsule. This innovative drug delivery system has a number
of unique advantages based on its gastric retentive properties.
With the Accordion Pill, drug is released slowly in the stomach
over hours, allowing the body to absorb it more steadily. When the
Accordion Pill is evacuated from the stomach, it simply dissolves
in the GI tract.
The Accordion Pill's drug release mechanism is independent of
its gastric retention mechanism and the Accordion Pill can combine
immediate and controlled-release profiles, thus allowing
considerable flexibility in developing and/or optimizing a variety
of therapies.
This novel drug delivery system can improve PK, allows for high
drug loading and is ideally suited for compounds with narrow
absorption windows, poor solubility or that act locally in the
stomach or upper gastrointestinal area. Importantly, the
Accordion Pill's safety and efficacy have been tested in more than
30 clinical studies since Intec's inception.
About Intec Pharma Ltd.
Intec Pharma is a
clinical-stage biopharmaceutical company focused on developing
drugs based on its proprietary Accordion Pill platform technology.
The Company's Accordion Pill is an oral drug delivery system that
is designed to improve the efficacy and safety of existing drugs
and drugs in development by utilizing an efficient gastric
retention and specific release mechanism. The Company's product
pipeline includes two product candidates in clinical trial stages:
Accordion Pill Carbidopa/Levodopa, or AP-CD/LD, which is in
late-stage Phase 3 development for the treatment of Parkinson's
disease symptoms in advanced Parkinson's disease patients, and
AP-cannabinoids, an Accordion Pill to deliver either or both of the
primary cannabinoids contained in Cannabis sativa, cannabidiol
(CBD) and tetrahydrocannabinol (THC) for various pain
indications.
For more information, visit www.intecpharma.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward looking statements about our
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 are based on assumptions and assessments
made in light of management's experience and perception of
historical trends, current conditions, expected future developments
and other factors believed to be appropriate. Forward-looking
statements in this press release are made as of the date of this
press release, and we undertake no duty to update or revise any
such statements, whether as a result of new information, future
events or otherwise. Forward-looking statements are not guarantees
of future performance and are subject to risks and uncertainties,
many of which are outside of our control. Many factors could cause
our actual activities or results to differ materially from the
activities and results anticipated in forward-looking statements,
including, but not limited to, the following: our limited operating
history and history of operating losses, our ability to continue as
a going concern, our ability to obtain additional financing, our
ability to successfully operate our business or execute our
business plan, the timing and cost of our clinical trials, the
completion and receiving favorable results in our clinical trials,
our ability to obtain and maintain regulatory approval of our
product candidates, our ability to protect and maintain our
intellectual property and licensing arrangements, our ability to
develop, manufacture and commercialize our product candidates, the
risk of product liability claims, the availability of
reimbursement, and the influence of extensive and costly government
regulation. More detailed information about the risks and
uncertainties affecting us is contained under the heading "Risk
Factors" included in our most recent Annual Report on Form 20-F
filed with the SEC on March 9, 2018, and in other
filings that we have made and may make with the Securities and
Exchange Commission in the future.
Intec Pharma Investor Contact:
Anne Marie Fields
VP-Corporate Communications & Investor Relations
+972-646-200-8808
amf@intec-us.com
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SOURCE Intec Pharma Ltd.