TEL AVIV, Israel, Oct. 6, 2017 /PRNewswire/ -- Therapix
Biosciences Ltd. (Nasdaq: TRPX) ("Therapix" or the "Company"), a
specialty, clinical-stage pharmaceutical company focusing on the
development of cannabinoid-based treatments, today announced it has
entered into an exclusive agreement with Catalent Pharma Solutions,
the leading global provider of advanced delivery technologies and
development solutions for drugs, biologics and consumer health
products, for the formulation, development and clinical
manufacturing of THX-TS01, a first-in-class, proprietary
investigational drug candidate for the treatment of the symptoms of
Tourette Syndrome.
Pursuant to the agreement, Catalent will develop THX-TS01 in
softgel form in support of Therapix's clinical development program
and in accordance with current good manufacturing practice (cGMP).
The formulation, development, analytical and cGMP manufacturing
activities will be conducted at Catalent's primary softgel
development and manufacturing facility in St. Petersburg, Florida.
Ascher Shmulewitz, M.D., Ph.D.,
Therapix's Chairman of the Board of Directors, said, "This is the
first time that two cannabinoids, Tetrahydrocannabinol and
Palmitoylethanolamide, which we believe work synergistically, are
being combined in a proprietary single dose that may potentially
provide a turnkey solution to addressing the symptoms of Tourette
Syndrome. Our objective in developing THX-TS01 is to enable the
commercialization of a more effective treatment for the symptoms of
this devastating, unmet medical need. We believe that this
agreement may bring us one step closer to this goal."
Dr. Shmulewitz continued, "This agreement with Catalent—a
world-class drug development, delivery and supply
organization—reflects our belief in the promise of THX-TS01 as we
look forward to advanced-stage clinical trials and, if successful,
commercialization. We could not be more pleased with Catalent as
our new development and manufacturing partner."
"The potential benefits of combining Tetrahydrocannabinol and
Palmitoylethanolamide into a fully-optimized single dose, are
manifold," said Adi Zuloff-Shani, Ph.D., Therapix's Chief
Technology Officer. "This unique formulation could offer an
enhanced biological effect and extended duration greater than that
presented by administration of each component on its own."
About Therapix Biosciences
Therapix Biosciences Ltd. is a specialty clinical-stage
pharmaceutical company led by an experienced team of senior
executives and scientists. Our focus is creating and enhancing a
portfolio of technologies and assets based on cannabinoid
pharmaceuticals. With this focus, the company is currently engaged
in two internal drug development programs based on repurposing an
FDA approved synthetic cannabinoid (dronabinol): THX-TS01 targets
the treatment of the symptoms of Tourette Syndrome; and THX-ULD01
targets the high-value and under-served market of mild cognitive
impairments and Traumatic Brain Injury (TBI). Please visit our
website for more information at www.therapixbio.com.
About Catalent:
Catalent is the leading global provider of advanced delivery
technologies and development solutions for drugs, biologics and
consumer health products. With over 80 years serving the industry,
Catalent has proven expertise in bringing more customer products to
market faster, enhancing product performance and ensuring reliable
clinical and commercial product supply. Catalent employs
approximately 10,000 people, including over 1,400 scientists, at
more than 30 facilities across five continents, and in fiscal 2017
generated more than $2 billion in
annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information,
visit www.catalent.com.
More products. Better treatments. Reliably supplied.™
About THX-TS01
THX-TS01 is a combination drug candidate for the treatment of
the symptoms of Tourette Syndrome and it is based on two
components: (1) dronabinol, the active ingredient in an FDA
approved synthetic analog of tetrahydrocannabinol ("THC"), which is
the psychoactive molecule in the cannabis plant, and (2)
palmitoylethanolamide ("PEA"), which is an endogenous fatty acid
amide that belongs to the class of nuclear factor agonists, which
are proteins that regulate the expression of genes. The combination
of THC and PEA may induce a reaction known as the "entourage
effect." The basic tenet of the entourage effect is that
cannabinoids work together, or possess synergy, and affect the body
in a mechanism similar to the body's own endocannabinoid system,
which is a group of molecules and receptors in the brain that
mediates the psychoactive effects of cannabis. This entourage
effect may account for the pharmacological actions of PEA. Based on
an activity enhancement of other physiological compounds, PEA may
indirectly stimulate the cannabinoid receptors by potentiating
their affinity for a receptor or by inhibiting their metabolic
degradation, and by doing so, may increase the uptake of
cannabinoid compounds, such as THC. Thus, it is speculated that the
presence of the PEA molecule likely increases the efficacy of
orally administered THC, while reducing the required dosage and
decreasing associated deleterious adverse events.
About Tourette Syndrome
Tourette Syndrome is a neuropsychiatric disorder, characterized
by physical (motor) tics and vocal (phonic) tics. Motor or phonic
tics are sudden, brief, intermittent, involuntary or semi-voluntary
movements or sounds, respectively. They typically consist of brief,
coordinated, repetitive movements, gestures, or utterances that
mimic fragments of normal behavior. The tics associated with
Tourette Syndrome can have significant effects on the academic and
social development of children as well as affecting their overall
self-esteem and mental health. Although the majority of children
experience a decrease in their tics during adolescence, the worst
symptoms are usually experienced by adults with intractable
Tourette Syndrome.
Forward-Looking Statements
This 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. Such
forward-looking statements used in this press release include,
among other things, references to the clinical and commercial
potential of THX-TS01 for the treatment of Tourette Syndrome.
Actual results could differ from those projected in any
forward-looking statements due to numerous factors. Such factors
include, among others, our ability to raise the additional funding
needed to continue to pursue our business and product development
plans, the inherent uncertainties associated with developing new
products or technologies, our ability to obtain regulatory approval
for our product candidates, our ability to commercialize our
product candidates, competition in the industry in which we operate
and overall market conditions. 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 Therapix
Biosciences Ltd.'s annual report on Form 20-F dated May 1, 2017 filed with the SEC, which is
available on the SEC's website, www.sec.gov.
For further information:
Investor Contact:
Josh Blacher, CFO, Therapix
Biosciences, josh@therapixbio.com
Therapix Biosciences Ltd.
Media Contact:
Susan
Forman, DGI
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SOURCE Therapix Biosciences Ltd