Filed pursuant to Rule 424(b)(3)
Registration No. 333-226239
PROSPECTUS SUPPLEMENT NO. 21
(To Prospectus
dated August 8, 2018)
INTELLIPHARMACEUTICS INTERNATIONAL INC.
Common Shares
This Prospectus
Supplement No. 21 (this “Prospectus Supplement”) amends and supplements our
Prospectus dated August 8, 2018, as previously supplemented (the
“Prospectus”), which form a part of our
Registration Statement (our “Registration Statement”) on Form F-1 (Registration No.
333-226239). This Prospectus Supplement is being filed to update,
amend and supplement the information included or incorporated by
reference in the Prospectus with the information contained in this
Prospectus Supplement. The Prospectus and this Prospectus
Supplement relate to the resale, from time to time, of up to
6,858,334 common shares by certain of our shareholders identified
in the Prospectus.
This Prospectus
Supplement includes information from our Report on Form 6-K, which
was filed with the Securities and Exchange Commission on February
20, 2019. The Report, as filed, is set forth below.
This Prospectus
Supplement should be read in conjunction with the Prospectus,
except to the extent that the information in this Prospectus
Supplement updates and supersedes the information contained in the
Prospectus.
NEITHER THE U.S. SECURITIES AND EXCHANGE COMMISSION (THE
“SEC”) NOR ANY STATE SECURITIES COMMISSION OR CANADIAN
SECURITIES REGULATOR HAS APPROVED OR DISAPPROVED OF THESE
SECURITIES OR DETERMINED IF THIS PROSPECTUS SUPPLEMENT IS TRUTHFUL
OR COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL
OFFENSE.
_______________
The date of this
Prospectus Supplement is February 20, 2019
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 February 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.
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)
/s/ Dr. Amina Odidi
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Date: February 20,
2019
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Dr. Amina
Odidi
President, Chief Operating Officer and
Co-Chief Scientist
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EXHIBIT LIST
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Exhibit
|
Description
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99.1
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News release dated
February 20, 2019 -
Intellipharmaceutics Announces FDA
Tentative Approval of Generic Pristiq(R)
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EXHIBIT
99.1
Intellipharmaceutics
Announces FDA Tentative Approval of Generic
Pristiq®
Toronto, Ontario, February 20, 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 received tentative
approval from the U.S. Food and Drug Administration
(“FDA”) for the Company’s abbreviated new drug
application (“ANDA”) for desvenlafaxine
extended-release tablets in the 50 and 100 mg strengths. The
approved product is a generic equivalent of the branded product
Pristiq® sold in the U.S. by Wyeth Pharmaceuticals, LLC
(“Wyeth”).
Desvenlafaxine
extended-release tablets are a serotonin and norepinephrine
reuptake inhibitor (“SNRI”) indicated for the treatment
of major depressive disorder (“MDD”). The Company
previously announced that it had entered into a license and
commercial supply agreement with Mallinckrodt LLC ("Mallinckrodt"),
which granted Mallinckrodt, subject to its terms, an exclusive
license to market, sell and distribute in the U.S. the
Company’s desvenlafaxine extended-release tablets (generic
Pristiq®). Among other things, the agreement provides for the
Company to have a long-term profit sharing arrangement with respect
to the licensed product. Intellipharmaceutics has agreed to
manufacture and supply the licensed product exclusively for
Mallinckrodt on a cost-plus basis, and Mallinckrodt has agreed that
Intellipharmaceutics will be its sole supplier of the licensed
product marketed in the U.S.
Dr. Isa
Odidi, CEO of Intellipharmaceutics, stated, “We are quite
happy the FDA has granted tentative approval of our generic version
of Pristiq®. We believe the achievement of this milestone
demonstrates Intellipharmaceutics’ ability to successfully
take product candidates from development to regulatory approval and
speaks to the inherent potential of our product
pipeline.”
According
to Symphony Health Solutions Corporation, sales in the United
States for the 12 months ended January 2019 of Pristiq® and
all generic equivalents, were approximately $279 Million (in 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 several other generic versions of this
product are currently available that serve to limit the overall
market opportunity for this product. There can be no assurance that
the Company's desvenlafaxine extended-release tablets in the 50 or
100 mg strengths will receive final FDA approval or, if approved,
that they will be successfully commercialized and produce
significant revenue for us.
For more information regarding the Company’s agreement with
Mallinckrodt, see the Company’s filings with the Securities
and Exchange Commission.
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 FDA approval) in various
stages of development. The Company has 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
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.
The information attributed to Symphony Health Solutions Corporation
herein is provided as is, and Symphony makes no representation
and/or warranty of any kind, including but not limited to, the
accuracy and/or completeness of such information.
CONTACT INFORMATION
Company
Contact:
Intellipharmaceutics
International Inc.
Greg
Powell
Chief
Financial Officer
416.798.3001
ext. 106
investors@intellipharmaceutics.com
Investor
Contact:
ProActive
Capital
Kirin
Smith
646.863.6519
ksmith@pcgadvisory.com