Intellipharmaceutics International Inc.
(NASDAQ:IPCI) and (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
its U.S. marketing partner, Par Pharmaceutical Inc. (“Par”), has
launched the 5 and 40 mg strengths of its generic Focalin XR®
(dexmethylphenidate hydrochloride extended-release) capsules in the
U.S. The launch of the 5 and 40 mg strengths complements the
10, 15, 20, 25, 30 and 35 mg strengths of generic Focalin XR®
previously launched and marketed by Par. Under a licensing
and commercialization agreement between the Company and Par, the
Company receives quarterly profit-share payments on Par's U.S.
sales of generic Focalin XR®.
“The Par launch of the 5 and 40 mg strengths now
provides us with the full line of generic Focalin XR® strengths
available in the U.S. market,” said Dr. Isa Odidi, Chief Executive
Officer and co-founder of Intellipharmaceutics. “We expect
that making available the full complement of generic Focalin XR®
strengths will be seen as a benefit by wholesale purchasers of our
product.”
Focalin XR®, a drug used in the treatment of
attention deficit hyperactivity disorder, is marketed by Novartis
Pharmaceuticals Corporation. According to Symphony Health
Solutions, sales for the 12 months ended October 31, 2017 of
Focalin XR® (branded and generic) in the 5 and 40 mg strengths,
respectively, in the U.S. were approximately US$71 million and
US$43 million (TRx MBS Dollars, which represents projected new and
refilled prescriptions representing a standardized dollar metric
based on manufacturer's published catalog or list prices to
wholesalers, and does not represent actual transaction prices and
does not include prompt pay or other discounts, rebates or
reductions in price). According to Symphony Health Solutions,
sales in the United States for the 12 months ended October 31, 2017
of 5, 10, 15, 20, 25, 30, 35 and 40 mg strengths of Focalin XR®
(branded and generic) were approximately US$801 million (TRx MBS
Dollars). There can be no assurance that the Company's
generic Focalin XR® in the additional 5 and 40 mg strengths will 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
U.S. Food and Drug Administration (“FDA”) approval) in various
stages of development. The Company has abbreviated new drug
application (“ANDA”) and new drug application (“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, and 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 including risks or
uncertainties related to our ability to implement and execute a
plan to regain compliance with NASDAQ continued listing standards,
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, seasonal fluctuations in the number of prescriptions
written for our Focalin XR® product which may produce substantial
fluctuations in revenue, 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 hydrochloride extended release tablets (“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.
The information attributed to Symphony Health Solutions
Corporation herein is provided as is, and Symphony makes no
representation and/or warranty of any kind, including but not
limited to, the accuracy and/or completeness of such
information.
Company Contact: Intellipharmaceutics
International Inc. Andrew Patient 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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