EXHIBIT
99.1
Intellipharmaceutics Provides
Operational Update
TORONTO,
September 5, 2017 -- 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 operational update on its RexistaTM program,
intellectual property (IP) portfolio, and drug development and
commercialization progress.
“While
we were disappointed with the July 26, 2017 advisory
committee’s overall vote, we remain strongly confident in the
potential commercial opportunity for RexistaTM and continue to
execute based on this belief,” said Dr. Isa Odidi, Chief
Executive Officer and co-founder of Intellipharmaceutics. “As
we await the United States Food and Drug Administration
(“FDA”) decision on our RexistaTM New Drug
Application (“NDA”) by the September 25, 2017
Prescription Drug User Fee Act (“PDUFA”) goal date, we
are working diligently on initiating a previously planned Category
3 study shortly to support certain label claims. We currently
anticipate this study will take nine months from commencement to
complete.
“Our
drug development and commercialization initiatives remain on track,
and we believe that our product portfolio positions us well for
growth. Furthermore, strengthening our PODRASTM overdose
technology’s patent portfolio is a positive development as we
progress toward initiating the proof of concept trials in humans
required to bring this potentially differentiating technology to
market.”
RexistaTM
Abuse-Deterrent Extended Release Oxycodone Program
Update
Intellipharmaceutics
is in the process of commencing its planned Category 3 human abuse
potential study to provide additional data to support the
intranasal route of abuse-deterrent labeling claims for
RexistaTM.
The FDA continues its review of RexistaTM, with a PDUFA goal
date of September 25, 2017 for completion of its review of the
product’s NDA. The submission is supported by Category 1
abuse-deterrent studies and pivotal pharmacokinetic studies that
demonstrated that RexistaTM is
bioequivalent to Purdue Pharma L.P.’s (“Purdue”)
OxyContin® (oxycodone
hydrochloride extended release) and can be administered with or
without a meal (i.e., no food effect).
A trial
date for the previously announced patent litigation by Purdue
against the Company regarding RexistaTM has been set for
October 22, 2018. The FDA is stayed from granting approval of
RexistaTM
until August 24, 2019 unless the court declares Purdue’s
patents to be invalid, or not infringed; or the matter is otherwise
settled among the parties. The Company believes that it does not
infringe the subject patents and that it has a well-prepared
strategy to vigorously defend against the claims.
Intellectual Property Portfolio Update
PODRASTM
Technology
In
December 2016, the Company announced the grant of U.S. Patent No.
9,522,119 and Canadian Patent No. 2,910,865 in respect of
“Compositions and Methods for Reducing Overdose”.
The issued patents cover aspects of the Company's Paradoxical
OverDose Resistance Activating System (“PODRAS™”)
delivery technology, which is designed to prevent overdose when
more pills than prescribed are swallowed intact.
Intellipharmaceutics continues to make progress regarding its
PODRAS™ delivery technology, obtaining two additional patents
from the U.S. Patent and Trademark Office (U.S. Patent Nos. 9700515
and 9700516) also entitled "Compositions and Methods for Reducing
Overdose" and covering aspects of the Company's PODRAS™
delivery technology.
Drug Development and Commercialization Update
Generic Seroquel XR® and Generic
Focalin XR®
Intellipharmaceutics’
marketing and distribution partner, Mallinckrodt LLC
(“Mallinckrodt”) launched all strengths of Generic
Seroquel XR® (quetiapine fumarate extended-release tablets) in
the U.S. in June 2017. The Company’s marketing and
distribution partner, Par Pharmaceutical Inc. (“Par”),
has launched several strengths of generic Focalin XR®
(dexmethylphenidate hydrochloride extended-release capsules) in the
U.S. and the Company expects the remaining strengths to be
launched in the near future. Intellipharmaceutics continues to
work with Mallinckrodt and Par to gain traction in the competitive
U.S. market, and is actively pursuing opportunities it has
identified outside of the U.S. to expand global market
reach.
Other Products
Intellipharmaceutics
continues to pursue partnering opportunities of its other
Abbreviated New Drug Application (“ANDA”), Abbreviated
New Drug Submission (“ANDS”) and NDA products and
product candidates in the U.S. The Company’s license and
commercial supply agreement with Mallinckrodt grants Mallinckrodt
an exclusive license to market, sell and distribute in the U.S., in
addition to generic Seroquel XR® (quetiapine fumarate
extended-release tablets), the following two products for which
ANDAs are currently under FDA review: generic Pristiq®
(desvenlafaxine extended-release tablets) and generic
Lamictal® XR™ (lamotrigine extended-release tablets).
The Company is also focused on optimizing manufacturing and
increasing marketing activities in non-U.S. markets to support
product sales.
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 ANDA and NDA 505(b)(2) drug product
candidates in its development pipeline. These include
Rexista™, 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
There
can be no assurance that we will not be required to conduct further
studies for RexistaTM, that the FDA will
ultimately approve the NDA for the sale of RexistaTM in the U.S. market,
or that it will ever be successfully commercialized. There can be
no assurance that generic Seroquel XR® or generic Focalin
XR® or any other Company product, or any particular strength,
will be successfully commercialized.
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", "confident", "prospects",
"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
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 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,
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, 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 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 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
RexistaTM
in particular, if a patent
infringement suit is filed against us, with respect to any
particular product candidates (such as in the case of
RexistaTM),
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.
Dr. Isa Odidi
Chairman, Chief Executive Officer and Co-Chief
Scientist
416.854.0909
investors@intellipharmaceutics.com
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Investor Contact:
ProActive Capital
Kirin Smith
646.863.6519
ksmith@proactivecapital.com
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