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 provided an update
on the progress of the product development programs for both its
Rexista™ Oxycodone Abuse Deterrent oxycodone hydrochloride extended
release tablets and for its Regabatin™ XR once-daily, non-generic
extended release version of pregabalin.
Rexista™ Oxycodone XR
Rexista™ Oxycodone XR is a non-generic extended
release formulation intended for the management of moderate to
severe pain when an around-the-clock analgesic is required. The
formulation is intended to present a significant barrier to
tampering when subjected to various forms of anticipated physical
and chemical manipulation commonly used by abusers. It is also
designed to prevent dose dumping when inadvertently co-administered
with alcohol. In addition, when crushed or pulverized and hydrated,
the proposed extended release formulation is designed to coagulate
instantaneously and entrap the drug in a viscous hydrogel, which is
intended to prevent syringing, injecting and snorting.
The Company recently submitted an Investigational
New Drug Application ("IND") to the United States Food and Drug
Administration ("FDA") for Rexista™ Oxycodone XR in anticipation of
the commencement of Phase III clinical trials. Planning has begun
for the Phase III trials that will examine the efficacy and safety
of Rexista™ Oxycodone XR in individuals with chronic low back
pain.
Intellipharmaceutics has recently conducted and
analyzed the results of three definitive open label, blinded,
randomized, crossover, Phase I pharmacokinetic clinical trials in
which Rexista™ Oxycodone XR was compared to Oxycontin™ under single
dose fasting, single dose steady-state fasting and single dose fed
conditions in healthy volunteers. Intellipharmaceutics has
received topline data results from all three studies. The first
study, a single dose steady-state fasting study, showed that
Rexista™ Oxycodone XR met the bioequivalence criteria (90 percent
confidence interval of 80 to 125 percent) for all matrices, i.e.,
on the measure of maximum plasma concentration or Cmax, the ratio
of Rexista™ Oxycodone XR to Oxycontin® was 94.95 percent (90
percent confidence interval of 81.29 to 110.89 percent) and on the
measure of area under the curve steady state (AUCss) the ratio of
Rexista™ Oxycodone XR to Oxycontin® was 100.54 percent (90 percent
confidence interval of 89.97 to 112.34 percent).
The second study, a single dose fasting study,
showed that Rexista™ Oxycodone XR met the bioequivalence criteria
(90 percent confidence interval of 80 to 125 percent) for all
matrices, i.e., on the measure of maximum plasma concentration or
Cmax, the ratio of Rexista™ Oxycodone XR to Oxycontin® was 92.69
percent (90 percent confidence interval of 80.26 to 107.04
percent), on the measure of area under the curve time (AUCt) the
ratio of Rexista™ Oxycodone XR to Oxycontin® was 100.53 percent (90
percent confidence interval of 95.13 to 106.53 percent) while on
the measure of area under the curve infinity (AUCinf) the ratio of
Rexista™ Oxycodone XR to Oxycontin® was 114.87 percent (90 percent
confidence interval of 108.21 to 121.93 percent).
The third study, a single dose fed study, showed
that Rexista™ Oxycodone XR met the bioequivalence criteria (90
percent confidence interval of 80 to 125 percent) for all matrices,
i.e., on the measure of maximum plasma concentration or Cmax, the
ratio of Rexista™ Oxycodone XR to Oxycontin® was 91.66 percent (90
percent confidence interval of 80.21 to 104.75 percent), on the
measure of area under the curve time (AUCt) the ratio of Rexista™
Oxycodone XR to Oxycontin® was 103.21 percent (90 percent
confidence interval of 94.15 to 113.15 percent) while on the
measure of area under the curve infinity (AUCinf) the ratio of
Rexista™ Oxycodone XR to Oxycontin® was 107.39 percent (90 percent
confidence interval of 98.62 to 107.39 percent).
Regabatin™ XR
The Company also reported that the FDA has accepted
a Pre-Investigational New Drug (Pre-IND) meeting request for its
once-a-day Regabatin™ XR non-generic controlled release version of
pregabalin under the new drug application ("NDA") 505(b)(2)
regulatory pathway, with a view to possible commercialization in
the United States at some time following the December 30, 2018
expiry of the patent covering the pregabalin
molecule. Regabatin™ XR is based on the Company's controlled
release drug delivery technology platform which utilizes the
symptomatology and chronobiology of fibromylagia in a formulation
intended to provide a higher exposure of pregabalin during the
first 12 hours of dosing.
Pregabalin is indicated for the management of
neuropathic pain associated with diabetic peripheral neuropathy,
postherpetic neuralgia, spinal cord injury and fibromyalgia. A
once-a-day controlled release version of pregabalin should reduce
the number of doses patients currently take, potentially improving
patient compliance, and thereby potentially improving clinical
outcomes. This Pre-IND request with the FDA is focused on the
Company's proposed Phase III clinical program.
There can be no assurance that additional clinical
trials will meet our expectations, that we will have sufficient
capital to conduct such trials, that we will be successful in
submitting any NDA with the FDA, that the FDA will approve these
product candidates for sale in the U.S. market, or that they will
ever be successfully commercialized.
"We are excited with the positive topline data
results of the Phase I studies utilizing formulations and dosages
of our Rexista™ Oxycodone XR product candidate, and we look forward
to the FDA's guidance on our IND filing on Rexista™ Oxycodone
XR, and on our Pre-IND submission for Regabatin™," stated
Dr. Isa Odidi, CEO and co-founder of Intellipharmaceutics. "We
believe that our abuse deterrent technology has the potential to
positively differentiate Rexista™ from other abuse deterrent
technologies of which we are aware, and that it represents an
important step towards helping patients manage their pain
safely. For both Rexista™ and Regabatin™, we plan to move
forward, subject to FDA guidance, into Phase III trials. We also
plan to explore potential strategic business development
relationships for these novel product candidates."
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
(our dexmethylphenidate hydrochloride extended-release capsules for
the 15 and 30 mg strengths which received final FDA approval) and
product candidates in various stages of development, including
Abbreviated New Drug Applications filed with the FDA in therapeutic
areas that include neurology, cardiovascular, gastrointestinal
tract, diabetes and pain.
Intellipharmaceutics also has NDA 505(b)(2) product
candidates in its development pipeline. These include Rexista™
Oxycodone XR, an abuse-deterrent oxycodone, based on its
proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System
and PODRAS™ Paradoxical OverDose Resistance Activating System, and
Regabatin™ XR pregabalin extended-release capsules.
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," "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 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 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, the difficulty of predicting the impact of competitive
products and pricing and the timing and success of product
launches, the seasonal fluctuation in the numbers of prescriptions
written for our dexmethylphenidate hydrochloride extended-release
capsules which may produce substantial fluctuations in revenues,
the timing and amount of insurance reimbursement for our products,
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, difficulties or
delays in manufacturing, the manufacturing capacity of third-party
manufacturers that we may use for our products, and the successful
compliance with FDA and other governmental regulations applicable
to the Company and its third party manufacturers' facilities,
products and/or businesses. 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.
CONTACT: 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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