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, at
the request of Investment Industry Regulatory Organization of
Canada (“IIROC”) on behalf of the Toronto Stock Exchange, confirms
that as of the date of this news release, they are not aware of any
corporate developments that would cause the recent movement in the
Company's share price.
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 (which have received final
United States Food and Drug Administration (“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 filed with Health Canada) in
therapeutic areas that include neurology, cardiovascular,
gastrointestinal tract, diabetes and pain.
Intellipharmaceutics also has New Drug Application (“NDA”)
505(b)(2) specialty drug product candidates in its development
pipeline. These include Rexista™ 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.
Cautionary Statement Regarding Forward-Looking
InformationCertain 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 in 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
launch of competitive products, the difficulty in predicting the
impact of competitive products on volume, pricing, rebates and
other allowances, the inability to forecast wholesaler demand
and/or wholesaler buying patterns, the seasonal fluctuation in the
numbers of prescriptions written for our Focalin XR®
(dexmethylphenidate hydrochloride extended-release) capsules which
may produce substantial fluctuations in revenues, the timing and
amount of insurance reimbursement for our products, changes in laws
and regulations affecting the conditions required by the FDA for
approval and labelling of drugs including abuse or overdose
deterrent properties, and changes affecting how opioids are
regulated and prescribed by physicians, 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, risks associated with
cyber-security and the potential for vulnerability of the digital
information of the Company or a current and/or future drug
development or commercialization partner of the Company and risks
arising from the ability and willingness of our third-party
commercialization partners to provide documentation that may be
required to support information on revenues earned by us from those
commercialization partners. 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.
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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