Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I)
("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 United States (“U.S.”)
marketing partner, Par Pharmaceutical (“Par”), has launched the 25
and 35 mg strengths of its generic Focalin XR®
(dexmethylphenidate hydrochloride extended-release) capsules in the
U.S. The U.S. Food and Drug Administration ("FDA") has
granted final approval to Par’s abbreviated new drug application
(“ANDA”) for its generic Focalin XR® capsules in the 5, 10,
15, 20, 25, 30, 35 and 40 mg strengths. The Company is unable to
state or estimate an actual launch date of any remaining strengths,
but currently intends to provide an update once it is advised by
Par of the launch of any additional strengths of its generic
Focalin XR®.
As the first filer of an ANDA for generic Focalin XR® in the 25
and 35 mg strengths, Par will have 180 days of U.S. generic
marketing exclusivity for those strengths. 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®.
Dr. Isa Odidi, the CEO and a co-founder of Intellipharmaceutics,
stated, "We are thrilled to begin the New Year with news of Par’s
launch, with 180 days of U.S. generic market exclusivity, of the 25
and 35 mg strengths of its generic Focalin XR®. The launch of these
additional strengths builds on the 15 and 30 mg strengths currently
marketed by Par, and should significantly improve our revenues in
2017."
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 November 2016 of Focalin XR® in the 25 and 35 mg
strengths, respectively, in the U.S. were approximately $66 million
and $14 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 as to whether
any of the recently-approved strengths of generic Focalin XR® 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® (abuse deterrent oxycodone
hydrochloride extended release tablets), 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,” “potential,”
“continue,” “intends,” “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, 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 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 for our products, changes in laws
and regulations affecting the conditions required by the FDA for
approval and labelling of drugs including abuse or overdose
deterrent properties, and changes affecting how opioids are
regulated and prescribed by physicians, changes in the laws and
regulations, including Medicare and Medicaid, affecting among other
things, pricing and reimbursement of pharmaceutical products, 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 product candidates,
the manufacturing capacity of third-party manufacturers that we may
use for our products, the successful compliance with FDA, Health
Canada and other governmental regulations applicable to the Company
and its third party manufacturers' facilities, products and/or
businesses, difficulties, delays or changes in the FDA approval
process or test criteria for ANDAs and NDAs, risks associated with
cyber-security and the potential for vulnerability of the digital
information of the Company or a current and/or future drug
development or commercialization partner of the Company 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 the Company 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.
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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