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 Mallinckrodt LLC
(“Mallinckrodt”), in its capacity as the Company’s marketing and
distribution partner, launched all strengths of the Company’s
generic Seroquel XR® (quetiapine fumarate extended-release tablets)
in the U.S. This launch follows the recent final
approval from the U.S. Food and Drug Administration ("FDA") for the
Company's abbreviated new drug application ("ANDA") for quetiapine
fumarate extended-release tablets in the 50, 150, 200, 300 and 400
mg strengths.
Dr. Isa Odidi, CEO and co-founder of Intellipharmaceutics,
stated, "We are pleased to share the news of our generic Seroquel
XR® launch by our valued partner Mallinckrodt. This is our second
ANDA to be commercialized in the U.S. and follows the recent
launches of 4 additional strengths of generic Focalin XR® by Par
Pharmaceutical, Inc. The launch of generic Seroquel XR® should
enhance the significant revenue improvement we have realized thus
far in 2017.”
Seroquel XR®, and the drug active quetiapine fumarate, are
indicated for use in the treatment of schizophrenia and bipolar
disorder. According to Symphony Health Solutions, sales in the
United States for the 12 months ended April 2017 of the 50, 150,
200, 300 and 400 mg strengths of Seroquel XR® (branded and generic)
were approximately U.S. $842 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). There can be no
assurance that the Company's generic Seroquel XR® in any of the 50,
150, 200, 300 and 400 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-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 FDA approval) and product candidates
in various stages of development, including 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™, 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 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, 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
collaborators 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 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 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,
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
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