Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:IPCI)
(“Intellipharmaceutics” or the “Company”), a pharmaceutical company
specializing in the research, development and manufacture of novel
and generic controlled- and targeted-release oral solid dosage
drugs, today provided an operational update on its plans and
projected timelines for the 2018 year.
“2017 marked a series of important
accomplishments that we believe will set the stage for growth in
2018 and beyond,” commented Dr. Isa Odidi, Chief Executive Officer
and co-founder of Intellipharmaceutics. “We continue to be
optimistic about our abuse-deterrent oxycodone hydrochloride
extended release tablets (Oxycodone ER) product candidate. The
complete response letter (CRL) from the FDA in our view was
favorable as it clarified concerns expressed by the FDA Advisory
Committees and the path for resubmission of the application. We
remain confident in the potential commercial opportunity for
Oxycodone ER, and our other drug development and commercialization
initiatives also remain on track. We believe that our product
portfolio positions us well for growth and look forward to further
executing on our plans into 2018.”
2017 key operational highlights
include:
- Intellipharmaceutics commenced in-house manufacture of its
first commercial product (all strengths of generic Seroquel XR®
(quetiapine fumarate extended-release) tablets) for export to the
United States.
- Intellipharmaceutics’ marketing and distribution partner,
Mallinckrodt LLC (“Mallinckrodt”) launched all strengths of generic
Seroquel XR® in the United States, providing us with the full line
of generic Seroquel XR® strengths available in the U.S.
market.
- Our marketing partner, Par Pharmaceutical, Inc. (“Par”)
completed the launch of all strengths of generic Focalin XR®
(dexmethylphenidate hydrochloride extended-release) capsules in the
United States, providing us with the full line of generic Focalin
XR® strengths available in the U.S. market.
- The United States Food and Drug Administration (“FDA”) accepted
for filing our new drug application (“NDA”) seeking authorization
to market our Oxycodone ER product candidate in the 10, 15, 20, 30,
40, 60 and 80 mg strengths.
- We received a complete response letter (the “CRL”) from the FDA
providing certain recommendations and requests for information
regarding our Oxycodone ER (formerly known as Rexista™) NDA.
- We received final approval from the FDA for our abbreviated new
drug application (“ANDA”) for metformin hydrochloride extended
release tablets in the 500 and 750 mg strengths (a generic
equivalent for the corresponding strengths of the branded product
Glucophage® XR sold in the United States by Bristol-Myers
Squibb).
- The Company announced the grant of additional U.S. Patents in
respect of “Compositions and Methods for Reducing Overdose”,
covering aspects of the Company's Paradoxical OverDose Resistance
Activating System (“PODRAS™”) delivery technology, which is
designed to prevent overdose when more pills than prescribed are
swallowed intact.
Drug Portfolio Update
Oxycodone ER Abuse-Deterrent
Program
The Company’s NDA for an abuse-deterrent version
of Oxycodone ER was accepted for filing by the FDA less than twelve
months ago. The submission was supported by Category 1
abuse-deterrent studies (to support intravenous abuse deterrent
label claim) and pivotal pharmacokinetic studies that demonstrated
that the product is bioequivalent to
OxyContin® (oxycodone hydrochloride extended release) and can
be administered with or without a meal (i.e., no food effect).
The joint meeting of the Anesthetic and
Analgesic Drug Products Advisory Committee and Drug Safety
and Risk Management Advisory Committee of the FDA held in July
2017 expressed a desire to review additional data for
Oxycodone ER that may be obtained from human abuse potential
studies for the oral and intranasal routes of administration.
The CRL from the FDA received in September 2017 clarified concerns
expressed by the advisory committees and the path for resubmission
of the application. Subsequent to receiving the CRL, the
Company immediately began preparing its response, including
finalizing protocols and plans to complete the Category 2 and 3
studies to support the application.
The planned studies to support both the oral and
intranasal route of abuse-deterrent label claims are scheduled to
commence within the next few weeks and expected to be take
approximately six months from commencement. We anticipate
that the NDA will be resubmitted to the FDA in late summer
2018. As previously announced, as a result of the patent
infringement proceedings against us in the United States launched
by Purdue Pharma L.P. et al (collectively, “Purdue”), the FDA is
stayed from granting approval of our Oxycodone ER product until
August 24, 2019 unless the court declares Purdue’s patents to be
invalid, or not infringed; or the matter is otherwise settled among
the parties. The Company believes that it does not infringe the
subject patents and that it has a well-prepared strategy to
vigorously defend against the claims. A trial date for Purdue
against the Company regarding the product has been set for October
22, 2018. With a resubmission of the NDA ahead of this date,
the Company anticipates that it will remain on its original
schedule with respect to commercialization at the earliest possible
opportunity.
Intellectual Property
Portfolio
PODRAS™ Technology
Intellipharmaceutics continues to make progress
regarding its PODRAS™ delivery technology, recently obtaining three
additional patents from the U.S. Patent and Trademark Office (U.S.
Patent Nos. 9700515 and 9700516 in July 2017 and No. 9,801,939 in
October 2017) also entitled "Compositions and Methods for Reducing
Overdose" and covering aspects of the Company's PODRAS™ delivery
technology. The Company is optimistic about the prospects of
this technology, which deliberately regulates the bioavailability
of active ingredients in both generic and non-generic medications
in a way that reduces the opportunity for overdose and/or
abuse. The Company is finalizing plans to initiate proof of
concept trials in humans. The Company believes that the
preclinical work on the technology to date has shown encouraging
results, but human trials are required to show that the technology
works as expected. The human studies for PODRAS™ are
expected to take place in the first half of 2018. Based on
the results of these studies, the Company will evaluate commercial
opportunities for the technology including potential out-licensing
as well as incorporation into products within our pipeline.
Drug Development and Commercialization
Progress
Generic Seroquel XR® and Generic Focalin XR®
Intellipharmaceutics’ marketing and distribution
partner, Mallinckrodt launched all strengths of generic Seroquel
XR® (quetiapine fumarate extended-release tablets) in the U.S. in
June 2017. With the launch of two additional strengths of generic
Focalin XR® (dexmethylphenidate hydrochloride extended-release
capsules) in November 2017, the Company’s marketing and
distribution partner, Par has now launched all strengths of
generic Focalin XR in the U.S. Intellipharmaceutics continues
to work with Mallinckrodt and Par to gain traction in the
competitive U.S. market, and is actively pursuing opportunities it
has identified outside of the U.S. to expand global market
reach. Regabatin™
XR
The Company has had in development a once-a-day
non-generic controlled release version of pregabalin (marketed in
the U.S. by Pfizer under the Lyrica® brand) under the NDA 505(b)(2)
regulatory pathway, with a view to possible commercialization in
the U.S. at some time following the December 30, 2018 expiry of the
patent covering the pregabalin molecule. Regabatin™ XR is based on
our controlled release drug delivery technology platform which
utilizes the symptomatology and chronobiology of fibromyalgia in a
formulation intended to provide a higher exposure of pregabalin
during the first 12 hours of dosing. The FDA has
recently approved Lyrica® CR, a branded controlled release
formulation of pregabalin. The Company believes its product
has significant additional benefits to anything currently on the
market and is very excited to continue development of its
formulation. We are currently evaluating partners for
required Phase III studies and expect to begin these studies in the
second half of 2018.
Other Products and Markets
Intellipharmaceutics continues to pursue
partnering opportunities of its other ANDA, Abbreviated New Drug
Submission (“ANDS”) and NDA products and product candidates, both
in the U.S. and internationally. The Company has a strong
pipeline of ANDAs. Two ANDAs have recently been approved and
others are in various stages of the FDA review process. While
commercialization opportunities for our product have been
challenging in the U.S. due to the extremely competitive cost
environment, the Company has been working with its supply partners
to reduce input costs and achieve efficiencies which we expect to
lead to new opportunities in the U.S.
In addition, the Company continues efforts to
identify opportunities overseas, including in China, that could if
effectuated provide product distribution alternatives through
partnerships and therefore do not require an investment or asset
acquisition by the Company. The Company recently visited
China where discussions toward establishing a partnership to
facilitate future development activities are ongoing. The
Company has not entered into any such arrangements at this
time. These opportunities could involve out-licensing of our
products, third-party manufacturing supply and more efficient
access to pharmaceutical ingredients and therefore assist with the
development of our growing product pipeline.
As the Company builds its product portfolio, we
are also seeking to add additional product development candidates
to our pipeline. We have received considerable interest and
are investigating several opportunities to develop products in
collaboration with international partners.
Year-end Financial Results
The Company is currently working to finalize its
2017 annual financial report and expects to set a release date
shortly. In addition to the release of the financial report,
management will also hold a conference call to discuss the results
and answer any questions. Details on the date and time, as
well as conference call information will be announced in the coming
days.
There can be no assurance that our products or
technologies will be successfully commercialized or produce
significant revenues for us. Also, there can be no assurance
that we will not be required to conduct further studies for our
Oxycodone ER product, that the FDA will approve any of the
Company’s requested abuse-deterrence label claims or that the FDA
will ultimately approve the NDA for the sale of our Oxycodone ER
product in the U.S. market, or that it will ever be successfully
commercialized, that we will be successful in submitting any
additional ANDAs or NDAs with the FDA or ANDSs with Health Canada,
that the FDA or Health Canada will approve any of our current or
future product candidates for sale in the U.S. market and Canadian
market, or that they will ever be successfully commercialized or
partnered and 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- 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 Oxycodone ER abuse deterrent oxycodone
formulation 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 plans, goals, timelines 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 "expects", "plans", "anticipates", "believes",
"confident", "prospects", "potential", "intends", "look forward",
"would", “projected”, “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, uncertainties
and other factors that could affect our actual results include, but
are not limited to, 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 estimated proceeds (and the expected use of any
proceeds) we may receive from any offering or our securities,
potential liability from and costs of defending pending or future
litigation, our ability to maintain compliance with the continued
listing requirements of the principal markets on which our
securities are traded, 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
difficulty in predicting the timing and results of any product
launches, 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, sources of revenues
and anticipated revenues, including contributions from distributors
and commercial partners, product sales, license agreements and
other collaborative efforts for the development and
commercialization of product candidates, delays in product
approvals that may be caused by changing regulatory requirements,
the difficulty in predicting the timing of regulatory approval and
launch of competitive products, the availability and pricing of
third-party sourced products and materials, difficulties, delays,
or changes in the FDA approval process or test criteria for ANDAs
and NDAs challenges in securing final FDA approval for our product
candidates, including Oxycodone ER in particular, if a patent
infringement suit is filed against us, with respect to any
particular product candidates (such as in the case of Oxycodone
ER), which could delay the FDA's final approval of such product
candidates, and the FDA may not approve requested product labeling
for our product candidate(s) having abuse-deterrent properties
targeting common forms of abuse (oral, intra-nasal and
intravenous). Additional 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-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.
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. Dr. Isa
Odidi, Chairman, Chief Executive Officer and Co-Chief Scientist
416.854.0909 investors@intellipharmaceutics.com |
|
Investor
Contact: ProActive Capital Kirin Smith 646.863.6519
ksmith@pcgadvisors.com |
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