Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I)
("Intellipharmaceutics" or the "Company"), a pharmaceutical company
specializing in the research, development and manufacture of novel
and generic controlled-release and targeted-release oral solid
dosage drugs, today announced that the United States Food and Drug
Administration ("FDA") has reviewed the Company's request for Fast
Track designation for its abuse deterrent Rexista™ Oxycodone XR
(Oxycodone HCl) extended-release tablets development program
incorporating its Paradoxical OverDose Resistance Activating System
("PODRAS
™") and has concluded that it meets the
criteria for Fast Track designation.
Fast Track is a designation assigned by the FDA in response to
an applicant's request which meets FDA criteria. The designation
mandates the FDA to facilitate the development and expedite the
review of drugs intended to treat serious or life threatening
conditions and that demonstrate the potential to address unmet
medical needs. This could potentially result in accelerated
approval for Rexista™ Oxycodone XR thereby making it available to
patients earlier than would be traditionally possible.
In March 2015, the Company requested Fast Track designation for
its novel, and potentially first-in-class, Rexista™ Oxycodone XR
abuse deterrent oxycodone hydrochloride extended release tablets
incorporating its PODRAS™ technology platform. A
basis for the request was that Rexista™ Oxycodone XR has the
potential to address an unmet medical need, namely the prevention,
deterrence or reduction of the abuse of oxycodone HCl extended
release solid oral dosage forms involving the deliberate or
inadvertent oral ingestion of more intact pills or tablets than
prescribed to achieve a feeling of euphoria. This is a very common
and serious form of drug abuse.
Rexista™ Oxycodone XR is intended for the management of moderate
to severe pain when a continuous, around-the-clock analgesic is
needed for an extended period of time. Such medications are
considered important in the treatment of chronic pain, but have the
potential for abuse.
"We are pleased with the grant by the FDA of Fast Track status
for Rexista™ Oxycodone XR incorporating our proprietary PODRAS™
technology which is being formulated to decrease the 'liking' of
dose escalation and decrease or delay the attendant risk of
respiratory depression in drug-naive individuals. The development
of this product candidate could, if successful, decrease the
desirability of taking more intact tablets than prescribed,
potentially addressing an unmet need and possibly resulting in
fewer accidental or intentional deaths," stated Dr. Isa Odidi, CEO
and co-founder of Intellipharmaceutics. "To the best of our
knowledge, no other product currently approved for sale in the U.S.
or Canada has demonstrated this potential."
There can be no assurance that the Company will, as a result of
the Fast Track designation for Rexista™ Oxycodone XR, experience a
faster development process or review, compared to conventional FDA
standards, or that the Company's Rexista™ Oxycodone XR product
candidate will be approved at all, or that it will ever be
successfully commercialized.
About Rexista™ Oxycodone XR incorporating
PODRAS™
The Company's Rexista™ Oxycodone XR product candidate has been
further enhanced with its proprietary PODRAS™ delivery technology
intended to reduce the likelihood of oral abuse when more pills
than prescribed are swallowed intact. Preclinical studies of
Rexista™ Oxycodone XR suggest that if more tablets than prescribed
are deliberately or inadvertently swallowed, the amount of drug
active released over 24 hours may be substantially less than
expected. However, if the prescribed number of pills is swallowed,
the drug release should be as expected.
Details on the FDA Fast Track program can be found in the link
below:
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm122932.htm
About Intellipharmaceutics
Intellipharmaceutics International Inc. is a pharmaceutical
company specializing in the research, development and manufacture
of novel and generic controlled-release and targeted-release oral
solid dosage drugs. The Company's patented Hypermatrix™ technology
is a multidimensional controlled-release drug delivery platform
that can be applied to the efficient development of a wide range of
existing and new pharmaceuticals. Based on this technology
platform, Intellipharmaceutics has developed several drug delivery
systems and a pipeline of products (our dexmethylphenidate
hydrochloride extended-release capsules for the 15 and 30 mg
strengths which received final FDA approval) and product candidates
in various stages of development, including Abbreviated New Drug
Applications filed with the FDA (and one Abbreviated New Drug
Submission filed with Health Canada) in therapeutic areas that
include neurology, cardiovascular, gastrointestinal tract, diabetes
and pain.
Intellipharmaceutics also has New Drug Application 505(b)(2)
product candidates in its development pipeline. These include
Rexista™ Oxycodone XR, an abuse-deterrent oxycodone, based on its
proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System
and PODRAS™ Paradoxical OverDose Resistance Activating System, and
Regabatin™ XR pregabalin extended-release capsules.
Certain statements in this document constitute "forward-looking
statements" within the meaning of the United States Private
Securities Litigation Reform Act of 1995 and/or "forward-looking
information" under the Securities Act (Ontario). These statements
include, without limitation, statements expressed or implied
regarding our plans, goals and milestones, status of developments
or expenditures relating to our business, plans to fund our current
activities, statements concerning our partnering activities, health
regulatory submissions, strategy, future operations, future
financial position, future sales, revenues and profitability,
projected costs, and market penetration. In some cases, you can
identify forward-looking statements by terminology such as "may,"
"will," "should," "expects," "plans," "anticipates," "believes,"
"estimates," "predicts," "potential," "continue," "intends,"
"could," or the negative of such terms or other comparable
terminology. We made a number of assumptions in the preparation of
our forward-looking statements. You should not place undue reliance
on our forward-looking statements, which are subject to a multitude
of known and unknown risks and uncertainties that could cause
actual results, future circumstances or events to differ materially
from those stated in or implied by the forward-looking statements.
Risks, uncertainties and other factors that could affect our actual
results include, but are not limited to, the effects of general
economic conditions, securing and maintaining corporate alliances,
our estimates regarding our capital requirements, and the effect of
capital market conditions and other factors, including the current
status of our product development programs, on capital
availability, the potential dilutive effects of any future
financing and the expected use of any proceeds from any offering of
our securities, our programs regarding research, development and
commercialization of our product candidates, the timing of such
programs, the timing, costs and uncertainties regarding obtaining
regulatory approvals to market our product candidates, and the
timing and amount of any available investment tax credits, the
actual or perceived benefits to users of our drug delivery
technologies, products and product candidates as compared to
others, our ability to establish and maintain valid and enforceable
intellectual property rights in our drug delivery technologies,
products and product candidates, the scope of protection provided
by intellectual property for our drug delivery technologies,
products and product candidates, the actual size of the potential
markets for any of our products and product candidates compared to
our market estimates, our selection and licensing of products and
product candidates, our ability to attract distributors and
collaborators with the ability to fund patent litigation and with
acceptable development, regulatory and commercialization expertise
and the benefits to be derived from such collaborative efforts,
sources of revenues and anticipated revenues, including
contributions from distributors and collaborators, product sales,
license agreements and other collaborative efforts for the
development and commercialization of product candidates, our
ability to create an effective direct sales and marketing
infrastructure for products we elect to market and sell directly,
the rate and degree of market acceptance of our products, the
difficulty of predicting the impact of competitive products and
pricing and the timing and success of product launches, the
inability to forecast wholesaler demand and/or wholesaler buying
patterns, the seasonal fluctuation in the numbers of prescriptions
written for our dexmethylphenidate hydrochloride extended-release
capsules which may produce substantial fluctuations in revenues,
the timing and amount of insurance reimbursement for our products,
changes in the laws and regulations, including Medicare and
Medicaid, affecting among other things, pricing and reimbursement
of pharmaceutical products, the success and pricing of other
competing therapies that may become available, our ability to
retain and hire qualified employees, the availability and pricing
of third party sourced products and materials, difficulties or
delays in manufacturing, the manufacturing capacity of third-party
manufacturers that we may use for our products, and the successful
compliance with FDA, Health Canada and other governmental
regulations applicable to the Company and its third party
manufacturers' facilities, products and/or businesses. Additional
risks and uncertainties relating to the Company and our business
can be found in the "Risk Factors" section of our latest annual
information form, our latest Form 20-F, and our latest Form F-3
(including any documents forming a part thereof or incorporated by
reference therein), as well as in our reports, public disclosure
documents and other filings with the securities commissions and
other regulatory bodies in Canada and the U.S., which are available
on www.sedar.com and www.sec.gov. The forward-looking statements
reflect our current views with respect to future events and are
based on what we believe are reasonable assumptions as of the date
of this document, and we disclaim any intention and have no
obligation or responsibility, except as required by law, to update
or revise any forward-looking statements, whether as a result of
new information, future events or otherwise.
CONTACT: Company Contact:
Intellipharmaceutics International Inc.
Domenic Della Penna
Chief Financial Officer
416-798-3001 ext 106
investors@intellipharmaceutics.com
Investor Contact:
ProActive Capital
Kirin Smith
646-863-6519
ksmith@proactivecapital.com
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