UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT
TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of March 2015.
Commission File Number: 000-53805
Intellipharmaceutics International Inc.
(Translation of registrant's name into English)
30 WORCESTER ROAD TORONTO, ONTARIO M9W
5X2
(Address of principal executive office)
Indicate by check mark whether the registrant
files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F [ x ] Form 40-F [ ]
Indicate by check mark if the registrant
is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Note: Regulation S-T Rule 101(b)(1)
only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant
is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Note: Regulation S-T Rule 101(b)(7) only permits the
submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer
must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized
(the registrant's "home country"), or under the rules of the home country exchange on which the registrant's securities
are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed
to the registrant's security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission
or other Commission filing on EDGAR.
On March 30, 2015, the Registrant issued a news release, a copy
of which is attached hereto as Exhibit 99.1 and incorporated herein by reference.
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
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Intellipharmaceutics International
Inc.
(Registrant)
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Date: March 30, 2015 |
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/s/ DOMENIC DELLA PENNA
Domenic Della Penna
Chief Financial Officer
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EXHIBIT LIST
Exhibit |
Description |
99.1 |
News Release dated March 30, 2015--Intellipharmaceutics Reports Positive Topline Data Results from a Series of Phase I Clinical Trials of its Abuse-Deterrent Rexista™ Oxycodone XR Tablets, and files an IND for Rexista™ Oxycodone XR. |
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Exhibit 99.1
March 30, 2015
Intellipharmaceutics
Reports Positive Topline Data Results from a Series of Phase I Clinical Trials of its Abuse-Deterrent
Rexista™ Oxycodone XR Tablets, and files an IND for Rexista™ Oxycodone XR.
Intellipharmaceutics Submits and was
Granted a Pre-IND Meeting Request with the US FDA for its Regabatin™ XR (Pregabalin Extended Release Capsules) Drug Candidate.
TORONTO,
Mar 30, 2015 (GLOBE NEWSWIRE) -- 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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