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 January 2019.
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.
This Report of
Foreign Private Issuer on Form 6-K and the attached exhibit 99.1
shall be incorporated by reference into the Company's effective
Registration Statements on Form F-3, as amended and supplemented
(Registration Statement Nos. 333-172796 and 333-218297), filed with
the Securities and Exchange Commission, from the date on which this
Report is filed, to the extent not superseded by documents or
reports subsequently filed or furnished by Intellipharmaceutics
International Inc. under the Securities Act of 1933 or the
Securities Exchange Act of 1934.
Intellipharmaceutics Announces
Research and Development Program for a Pipeline of Pharmaceutical
Cannabidiol Based Products
Toronto, Ontario, January 07, 2019 Intellipharmaceutics International Inc. (NASDAQ
and 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 it
has commenced a research and development program of pharmaceutical
cannabidiol (“CBD”) based products.
The
Company believes that its current technology platforms could find
use in cannabidiol therapeutics.
To this
end the Company has filed provisional patent applications with the
United States Patent and Trademark Office pertaining to the
delivery and application of cannabinoid-based therapeutics. The
patent filings, together with certain of the Company’s
already issued drug delivery patents, are intended to form the
basis of the development of a pipeline of novel controlled-release
product candidates with CBD as the main active
ingredient.
The
Company is currently in talks with potential commercialization
partners in the cannabidiol industry and has identified a potential
supplier of CBD.
Intellipharmaceutics’
CEO, Dr. Isa Odidi, said, “We believe that our experience
with the research, development, manufacture, quality control and
regulatory filing of controlled-release novel dosage forms
incorporating controlled substances, such as opioids, together with
our existing suite of drug delivery technologies should provide us
with a significant competitive advantage in the pharmaceutical
cannabidiol market. We look forward to working with new partners in
this space to commercialize our new
innovations.”
Intellipharmaceutics
is the holder of a Health Canada Drug Establishment License
(“DEL”) and a dealer’s license under the
Narcotics Control Regulations (“NCR”). Under the NCR
license, Intellipharmaceutics is currently authorized to possess,
produce, sell and deliver drug products containing various
controlled substances, including CBD, in Canada.
According
to Health Canada, a DEL is required under the Canadian Food and
Drug Regulations (“FDR”) for any person to fabricate,
package/label, import, perform tests on, distribute or wholesale
authorized drugs. In addition to a DEL, an NCR dealer's license is
required for any person to conduct certain activities such as to
produce, make, assemble, sell, provide, transport, send or deliver
a narcotic, including CBD, which may be used as an ingredient in
those drugs.
“Our
pre-existing designation as a DEL holder and a licensed dealer of
CBD under the NCR is another example of why we believe
Intellipharmaceutics is well positioned to impact the space,”
said Dr. Isa Odidi. “We intend to be a pioneer in the new and
exciting evolution from older concepts of medical cannabidiol
products to more sophisticated pharmaceutical, CBD-based
products.”
The
Company intends to seek opportunities for the development of novel
delivery systems and the filing of patent applications specific to
the delivery and use of cannabinoids in the United States and
elsewhere. The United
States is a "first inventor to file" jurisdiction for patent
applications, which offers potential intellectual property
protection pertaining to cannabinoids.
There
can be no assurance that any of our provisional patent applications
will successfully mature into patents, or that any
cannabidiol-based product candidates we develop will ever be
successfully commercialized or produce significant revenue for
us.
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 a wide range of existing and new
pharmaceuticals. Intellipharmaceutics has developed several drug
delivery systems based on this technology platform, with a pipeline
of products (some of which have received U.S. Food and Drug
Administration (''FDA'') approval) in various stages of
development. The Company has abbreviated new drug application
(“ANDA”) and new drug application (“NDA”)
505(b)(2) drug product candidates in its development pipeline.
These include the Company’s abuse-deterrent oxycodone
hydrochloride extended release formulation (“Oxycodone
ER”) 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).
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
expectations regarding our plans, goals and milestones, status of
developments or expenditures relating to our business, plans to
fund our current activities, and statements concerning our
partnering activities, health regulatory submissions, strategy,
future operations, future financial position, future sales,
revenues and profitability, projected costs and market penetration,
the impact of significant new or changing government regulation in
the cannabis industry, and risks or uncertainties related to our
ability to comply with the Nasdaq and TSX continued listing
standards and our ability to develop and
implement a plan of compliance with the Nasdaq continued listing
standards acceptable to a Nasdaq Panel. In some cases, you can
identify forward-looking statements by terminology such as
“appear”, “unlikely”, “target”,
"may", "will", "should", "expects", "plans", "plans to",
"anticipates", "believes", "estimates", "predicts", "confident",
"prospects", "potential", "continue", "intends", "look forward",
"could", “would”, “projected”,
“goals”, “set to”, “seeking” 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
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-1 and Form F-3
(including any documents forming a part thereof or incorporated by
reference therein), as amended, 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.
CONTACT INFORMATION
Company
Contact:
Intellipharmaceutics
International Inc.
Isa
Odidi
Chief
Executive Officer
416.798.3001
ext. 102
investors@intellipharmaceutics.com
Investor
Contact:
ProActive
Capital
Kirin
Smith
646.863.6519
ksmith@pcgadvisors.com