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
pivotal bioequivalence trials of the Company’s Rexista™ Oxycodone
XR (abuse deterrent oxycodone hydrochloride) extended release
tablets, dosed under fasted and fed conditions, had demonstrated
bioequivalence to Oxycontin® (oxycodone hydrochloride) extended
release tablets as manufactured and sold in the United States by
Purdue Pharma LP. The study design was based on United States Food
and Drug Administration (“FDA”) recommendations and compared the
lowest and highest strengths of exhibit batches of the Company’s
Rexista™ Oxycodone XR to the same strengths of Oxycontin®. The
results show that the ratios of the pharmacokinetic metrics, Cmax,
AUC0-t and AUC0-f for Rexista™ vs. Oxycontin®, are within the
interval of 80% - 125% required by the FDA with a confidence level
exceeding 90%.
The Company had earlier announced, in March 2015, that topline
data results of three definitive Phase I pharmacokinetic clinical
trials (single dose fasting, single dose steady-state fasting, and
single dose fed), conducted on pilot batches of the Company’s
Rexista™ Oxycodone XR, all met the FDA bioequivalence criteria when
compared to the existing branded drug Oxycontin®.
The Company had also earlier announced, in May 2015, that the
FDA had provided the Company with notification regarding its
Investigational New Drug Application (“IND”) submission for
Rexista™ Oxycodone XR. The notification from the FDA had
stated that the Company would not be required to conduct Phase III
studies if bioequivalence to Oxycontin® was demonstrated.
Having now demonstrated such bioequivalence for its Rexista™
Oxycodone XR product to be marketed upon FDA approval, the Company
intends to complete the regulatory filing requirements and file a
New Drug Application (“NDA”) for Rexista™ Oxycodone XR with the FDA
within the next 6 months in accordance with the NDA 505(b)(2)
regulatory pathway. There can be no assurance that the FDA
will ultimately approve the NDA for the sale of Rexista™ Oxycodone
XR in the U.S. market, or that it will ever be successfully
commercialized.
“We take great pride in being the first pharmaceutical company,
to the best of our knowledge, to have demonstrated bioequivalence
in both fasted and fed conditions to the brand reference drug
Oxycontin®. This enables us to accelerate the development and
commercialization of our abuse deterrent Rexista™ Oxycodone XR
product candidate without the need for costly and time-consuming
Phase III efficacy trials,” stated Dr. Isa Odidi, CEO and
co-founder of Intellipharmaceutics. “We look forward to filing an
NDA within the next six months, which we hope will lead to a
positive contribution in addressing an unmet need in opioid abuse
and addiction.”
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 15 and 30 mg
strengths which received final FDA approval) and product candidates
in various stages of development, including Abbreviated New Drug
Applications (“ANDAs “) filed with the FDA (and one Abbreviated New
Drug Submission (“ANDS”) filed with Health Canada) in
therapeutic areas that include neurology, cardiovascular,
gastrointestinal tract, diabetes and pain.
Intellipharmaceutics also has NDA 505(b)(2) specialty drug
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. Our current
development effort is increasingly directed towards improved
difficult-to-develop controlled-release drugs which follow an NDA
505(b)(2) regulatory pathway. The Company has increased its
research and development emphasis towards new product development,
facilitated by the 505(b)(2) regulatory pathway, by advancing the
product development program for both Rexista™ and Regabatin™.
The 505(b)(2) pathway (which relies in part upon the approving
agency’s findings for a previously approved drug) both accelerates
development timelines and reduces costs in comparison to NDAs for
new chemical entities. An advantage of our strategy for development
of NDA 505(b)(2) drugs is that our product candidates can, if
approved for sale by the FDA, potentially enjoy an exclusivity
period which may provide for greater commercial opportunity
relative to the generic ANDA route.
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,” “plans to,”
“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 ability to
maintain compliance with the continued listing requirements of the
principal markets on which our securities are traded, 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 difficulty of predicting the
timing and results of any product launches, 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, delays
that may be caused by changing regulatory requirements, the
difficulty in predicting the timing of regulatory approval and the
timing of launch of competitive products, the difficulty of
predicting the impact of competitive products on volume and
pricing, 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, 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, difficulties, delays or changes in the FDA approval
process or test criteria for ANDAs and NDAs and risks associated
with cyber-security and vulnerability of the Company’s digital
information and the digital information of the Company’s
commercialization partner(s). 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
IntelliPharmaCeutics (QB) (USOTC:IPCIF)
Historical Stock Chart
From Mar 2024 to Apr 2024
IntelliPharmaCeutics (QB) (USOTC:IPCIF)
Historical Stock Chart
From Apr 2023 to Apr 2024