EXHIBIT
99.1
Intellipharmaceutics Receives Complete
Response Letter from the FDA for RexistaTM NDA
FDA Response Provides Path toward Commercialization of
RexistaTM
TORONTO, September 25, 2017 (GLOBE NEWSWIRE) --
Intellipharmaceutics International Inc. (Nasdaq:IPCI)
(TSX:IPCI) (“Intellipharmaceutics” or the
“Company”), a pharmaceutical company specializing in
the research, development and manufacture of novel and generic
controlled- and targeted-release oral solid dosage drugs, today
provided an update on its RexistaTM, henceforth referred to as Oxycodone
Hydrochloride Extended-Release Tablets (“Oxycodone ER”),
program.
The Company has received a Complete Response Letter
(“CRL”) from the United States Food and Drug
Administration (“FDA”) for its Oxycodone ER New Drug
Application (“NDA”). In its CRL, the FDA provided
certain recommendations and requests for
information, including that
Intellipharmaceutics complete the relevant Category 2 and Category
3 studies to assess the abuse-deterrent properties of Oxycodone ER
by the oral and nasal routes of administration. The FDA also
requested additional information related to the inclusion of
the blue dye in the Oxycodone ER formulation, which is
intended to deter
abuse. The
FDA has determined that it cannot approve the application in its
present form.
“We are very encouraged by the FDA’s response as it
clarifies our path forward for Oxycodone ER,” said, Dr. Isa
Odidi, CEO of Intellipharmaceutics. “We had already planned
the additional Category 2 and Category 3 studies the FDA has
requested and we do not expect they will impact our anticipated
commercialization timeline for Oxycodone ER.”
Intellipharmaceutics has been given one year to respond to the CRL,
and can request additional time if necessary. The FDA has also
requested that Intellipharmaceutics submit an alternate proposed
proprietary name for Oxycodone ER.
Dr. Odidi concluded, “We will continue to work closely with
the FDA to provide them with the additional information they
requested, including data supporting the label claims related to
Oxycodone ER’s abuse-deterrent properties. We believe our
Oxycodone ER product can play
an important preventative role in the midst of a serious opioid
abuse crisis particularly impacting North America. The Company will
be providing regular updates as we execute on our Oxycodone ER NDA
resubmission plan.”
There
can be no assurance that Intellipharmaceutics will not be required
to conduct further studies for Oxycodone ER, that the FDA will approve any
of the Company's requested abuse-deterrent label claims or that the
FDA will ultimately approve the NDA for the sale of Oxycodone ER in the U.S.
market, or that it will ever be successfully
commercialized.
About Intellipharmaceutics
Intellipharmaceutics
International Inc. is a pharmaceutical company specializing in the
research, development and manufacture of novel and generic
controlled- 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 a wide range of existing and new pharmaceuticals.
Intellipharmaceutics has developed several drug delivery systems
based on this technology platform, with a pipeline of products
(some of which have received FDA approval) in various stages of
development. The Company has Abbreviated New Drug Application
(“ANDA”) and NDA 505(b)(2) drug product candidates in
its development pipeline. These include our Oxycodone ER product, an abuse deterrent
oxycodone based on its proprietary nPODDDS™ novel Point Of
Divergence Drug Delivery System (for which an NDA has been filed
with the FDA), and Regabatin™ XR (pregabalin extended-release
capsules).
Cautionary Statement Regarding Forward-Looking
Information
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
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projected costs and market penetration. In some cases, you can
identify forward-looking statements by terminology such as "may",
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"potential", "continue", "intends", "look forward", "could", or the
negative of such terms or other comparable terminology. We made a
number of assumptions in the preparation of our forward-looking
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known and unknown risks and uncertainties that could cause actual
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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 estimated proceeds (and the expected use of any
proceeds) we may receive from any offering of our securities,
the potential dilutive effects of any future
financing, potential
liability from and costs of defending pending or future litigation,
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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, the timing and amount of profit-share payments from our
commercial partners, 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/or commercial partners with the ability to
fund patent litigation and with acceptable product 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
commercial partners, 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 in product approvals 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 number of competitive product entries, and the
nature and extent of any aggressive pricing and rebate activities
that may follow, the inability to forecast wholesaler demand and/or
wholesaler buying patterns, the timing and amount of insurance
reimbursement regarding our products, changes in laws and
regulations affecting the conditions required by the FDA for
approval, testing and labeling of drugs including abuse or overdose
deterrent properties, and changes affecting how opioids are
regulated and prescribed by physicians, changes in laws and
regulations, including Medicare and Medicaid, affecting among other
things, pricing and reimbursement of pharmaceutical products,
changes in U.S. federal income tax laws currently being considered,
including, but not limited to, the U.S. changing the method by
which foreign income is taxed and resulting changes to the passive
foreign investment company laws and regulations which may impact
our shareholders, 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, challenges related to the
development, commercialization, technology transfer, scale-up,
and/or process validation of manufacturing processes for our
products or product candidates, the manufacturing capacity of
third-party manufacturers that we may use for our products,
potential product liability risks, the recoverability of the cost
of any pre-launch inventory should a planned product launch
encounter a denial or delay of approval by regulatory bodies, a
delay in commercialization, or other potential issues, the
successful compliance with FDA, Health Canada and other
governmental regulations applicable to us and our third party
manufacturers' facilities, products and/or businesses, our reliance
on commercial partners, and any future commercial partners, to
market and commercialize our products and, if approved, our product
candidates, difficulties, delays, or changes in the FDA approval
process or test criteria for ANDAs and NDAs challenges in securing
final FDA approval for our product candidates, including our
Oxycodone ER product
in particular, if a patent infringement suit is filed against us,
with respect to any particular product candidates (such as in the
case of Oxycodone
ER), which could delay the
FDA's final approval of such product candidates, healthcare reform
measures that could hinder or prevent the commercial success of our
products and product candidates, the FDA may not approve requested
product labeling for our product candidate(s) having
abuse-deterrent properties targeting common forms of abuse (oral,
intra-nasal and intravenous), risks associated with cyber-security
and the potential for vulnerability of our digital information or
the digital information of a current and/or future drug development
or commercialization partner of ours, 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 us 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.
Trademarks used herein are the property of their respective
holders.
Unless the context otherwise requires, all references to "we,"
"us," "our," "Intellipharmaceutics," and the "Company" refer to
Intellipharmaceutics International Inc. and its
subsidiaries.
CONTACT INFORMATION
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Company Contact:
Intellipharmaceutics
International Inc.
Andrew Patient
Chief Financial Officer
416.798.3001
investors@intellipharmaceutics.com
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Investor Contact:
ProActive Capital
Kirin Smith
646.863.6519
ksmith@proactivecapital.com
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