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 announced that the Company today received final
approval from the U.S. Food and Drug Administration ("FDA") for the
Company's abbreviated new drug application ("ANDA") for metformin
hydrochloride extended release tablets in the 500 mg and 750 mg
strengths. The Company's newly approved product is a generic
equivalent for the corresponding strengths of the branded product
Glucophage® XR sold in the United States by Bristol-Myers Squibb.
Dr. Isa Odidi, the CEO and a co-founder of Intellipharmaceutics,
stated, "FDA approval of our application for a generic version
of Glucophage® XR provides further indication that the FDA is
making progress to clear its backlog of ANDA drug candidates under
review, and further validation of our core drug development and
regulatory capability. We are encouraged that some of the Company's
other 8 ANDA candidates may be accorded further attention
soon. We are actively evaluating options to realize commercial
returns from this new approval."
Glucophage® XR, and the drug active metformin, are indicated for
use in the management of type 2 diabetes treatment. According to
Symphony Health Solutions, sales in the United States for the 12
months ended January 2017 of the 500 mg and 750 mg strengths
of Glucophage® XR and all generic equivalents, were
approximately $591 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). The Company is aware
that other generic versions of this product are currently available
in the market. There can be no assurance that the Company's
metformin extended-release tablets for the 500 mg and 750 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 RexistaTM (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 RexistaTM 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”,
“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, 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, 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, challenges in securing
final FDA approval for our products or product candidates
including, RexistaTM in particular, if a patent infringement suit
is filed against us, which could delay the FDA’s final approval of
such product candidates, the FDA may not approve requested product
labeling for our product candidate(s) having abuse-deterrent
properties, 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