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") provided the Company with notification
regarding its Investigational New Drug Application ("IND")
submission for Rexista™ Oxycodone XR (Abuse Deterrent oxycodone
hydrochloride) extended release tablets. The notification from the
FDA stated that the Company will not be required to conduct Phase
III studies if bioequivalence to Oxycontin™ is demonstrated.
The Company had earlier announced, on March 30, 2015, that it
had submitted an IND to the FDA for Rexista™ Oxycodone XR in
anticipation of the commencement of Phase III clinical
trials. At the same time the Company had also announced that
topline data results of three definitive Phase I pharmacokinetic
clinical trials (single dose fasting, single dose steady-state
fasting, and single dose fed) all met the bioequivalence criteria
when compared to the existing branded drug Oxycontin™. The Company
believes, in light of these prior results, that it will not be
required to conduct Phase III studies, although no assurance to
that effect can be given.
The Company believes the FDA notification is significant as it
provides a basis for an accelerated development plan for its
Rexista™ Oxycodone XR product candidate, without the need for more
costly and time-consuming Phase III studies. The Company
intends to file a New Drug Application ("NDA") for Rexista™
Oxycodone XR (Abuse Deterrent oxycodone hydrochloride) extended
release tablets with the FDA within the next 6 to 12 months,
although no assurance to this effect can be given. Further,
there can be no assurance that the FDA will ultimately approve the
NDA for sale of Rexista™ Oxycodone XR in the U.S. market, or that
it will ever be successfully commercialized.
"We are thrilled with the FDA's positive acknowledgement, which
enables us to accelerate the development and commercialization of
our abuse deterrent Rexista™ Oxycodone XR product candidate,"
stated Dr. Isa Odidi, CEO and co-founder of Intellipharmaceutics.
"The avoidance of a Phase III trial eliminates a significant
financial hurdle. More importantly, it shortens the
development timeline and potential time to market."
Rexista™ Oxycodone XR
Rexista™ Oxycodone XR is the Company's non-generic extended
release formulation intended for the management of moderate to
severe pain when an around-the-clock analgesic is required. The
formulation is intended to present a significant barrier to
tampering when subjected to various forms of anticipated physical
and chemical manipulation commonly used by abusers. It is also
designed to prevent dose dumping when inadvertently or
intentionally co-administered with alcohol. In addition, when
crushed or pulverized and hydrated, the proposed extended release
formulation is designed to coagulate instantaneously and entrap the
drug in a viscous hydrogel, which is intended to prevent syringing,
injecting or snorting.
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 5, 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 NDA 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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