Blueprint
U.S. FDA acknowledges receipt of Intellipharmaceutics’
resubmission of Oxycodone ER New Drug Application, deems it a
complete response, and designates August 28, 2019 as goal date for
review
Toronto, Ontario, March 29, 2019 Intellipharmaceutics International
Inc. (OTCQB: ICPIF 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,
announced today that the U.S. Food and Drug Administration
(“FDA”) has acknowledged receipt of its resubmission of
the Oxycodone ER New Drug Application (“NDA”) filed on
February 28, 2019. The FDA has informed the Company that it
considers the resubmission a complete response to the September 22,
2017 action letter it issued in respect of the NDA. The FDA has
also assigned a Prescription Drug User Fee Act (PDUFA) goal date of
August 28, 2019.
There can be no assurance that Intellipharmaceutics will not be
required to conduct further studies for Oxycodone ER, that the FDA
will approve any of the Company's requested abuse-deterrent label
claims or that the FDA will meet its deadline for review and
ultimately approve the NDA for the sale of Oxycodone ER in the U.S.
market, or that it will ever 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 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 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 OTCQB and TSX
requirements. 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
registration statements (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.
Greg
Powell
Chief
Financial Officer
416.798.3001
ext. 106
investors@intellipharmaceutics.com
Investor
Contact:
PCG
Advisory
Kirin
Smith
646.863.6519
ksmith@pcgadvisory.com