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-release and
targeted-release oral solid dosage drugs, today announced that on
July 28, 2017, a purported class action complaint was filed in the
U.S. District Court for the Southern District of New York (No.
1:17-cv-05761) by Shawn Shanawaz on behalf of himself and all
others similarly situated against the Company and two of its
executive officers.
The complaint alleges that the Company and the executive
officers violated Sections 10(b) and 20(a) of the Securities
Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by
making allegedly false and misleading statements or failing to
disclose certain information regarding the Company’s New Drug
Application (“NDA”) for Rexista™ abuse-deterrent oxycodone
hydrochloride extended release tablets. The complaint seeks,
among other remedies, unspecified damages, attorneys’ fees and
other costs, equitable and/or injunctive relief, and such other
relief as the court may find just and proper.
The Company and its management intend to vigorously defend
against the allegations set forth in the complaint. 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
(some of which have received U.S. 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 NDA 505(b)(2)
specialty 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). 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 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
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.
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 (TSX:IPCI)
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부터 1월(1) 2025 으로 2월(2) 2025
IntelliPharmaCeutics (TSX:IPCI)
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부터 2월(2) 2024 으로 2월(2) 2025