IntelGenx Announces Notice of Grant of European Patent Covering Rizaport® VersaFilm™
June 19 2018 - 8:00AM
IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) (the “Company” or
“IntelGenx”) today announced that the European Patent Office
(“EPO”) has issued a “Notice of Intention to Grant” for the
Company’s European Patent Application Number 14832172.2 entitled,
“Instantly Wettable Oral Film Dosage Form Without Surfactant or
Polyalcohol." This is the first key patent allowed in Europe
for the Company’s VersaFilm™ technology.
Once the administrative process is complete, the
patent that issues from this application will provide intellectual
property protection for the formulation of the Company’s VersaFilm™
technology used in its Rizaport® product, an oral thin film
formulation of rizatriptan benzoate for the treatment of acute
migraines, in Europe through 2034. IntelGenx received a
similar formulation patent covering its Rizaport® VersaFilm™
technology from the United States Patent and Trademark Office in
2016 and has additional applications pending in other
countries.
“This is a significant and exciting decision by
the EPO, and we view this announcement as recognition of IntelGenx’
important contributions to pharmaceutical oral films,” said Dr.
Horst G. Zerbe, President and CEO of IntelGenx.
About RIZAPORT® (RHB-103):
RIZAPORT® is a proprietary oral thin film
formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and
the active drug in Merck & Co.'s Maxalt®. RIZAPORT® 5 mg and 10
mg were approved for marketing in Germany in October 2015 and in
Luxembourg in April 2017 under the European Decentralized
Procedure. A New Drug Application for RIZAPORT® was resubmitted to
the U.S. FDA in October 2017.
Rizatriptan is considered to be one of the most
effective oral triptans, a class of molecules that constricts blood
vessels in the brain to relieve swelling and other migraine
symptoms. RIZAPORT® is based on IntelGenx's proprietary VersaFilm™
technology. It dissolves rapidly and releases its active ingredient
in the mouth, leading to efficient absorption of the drug through
the gastrointestinal tract. The administration method of the
RIZAPORT® oral soluble film, which does not require the patient to
swallow a pill or consume water, along with its neutral flavor,
presents a potentially attractive therapeutic alternative for
migraine patients, specifically for patients who suffer from
migraine-related nausea, estimated to be approximately 80% of the
total migraine patient population and patients suffering from
dysphagia (difficulty swallowing)1.
Reference:
1 Lipton RB, Buse DC, Saiers J, Fanning KM,
Serrano D, Reed ML. (2013) Frequency and burden of headache-related
nausea: results from the American Migraine Prevalence and
Prevention (AMPP) study, Headache. 2013 Jan;53(1):93-103.
About IntelGenx:
Established in 2003, IntelGenx is a leading oral
drug delivery company primarily focused on the development and
manufacturing of innovative pharmaceutical oral films based on its
proprietary VersaFilm™ technology platform.
IntelGenx' highly skilled team provides
comprehensive pharmaceuticals services to pharmaceutical partners,
including R&D, analytical method development, clinical
monitoring, IP and regulatory services. IntelGenx'
state-of-the-art manufacturing facility, established for the
VersaFilm™ technology platform, supports lab-scale to pilot and
commercial-scale production, offering full service capabilities to
its clients. More information about the Company can be found at
www.intelgenx.com.
Forward Looking Statements:
This document may contain forward-looking
information about IntelGenx' operating results and business
prospects that involve substantial risks and uncertainties.
Statements that are not purely historical are forward-looking
statements within the meaning of Section 21E of the Securities
Exchange Act of 1934, as amended, and Section 27A of the Securities
Act of 1933, as amended. These statements include, but are not
limited to, statements about IntelGenx' plans, objectives,
expectations, strategies, intentions or other characterizations of
future events or circumstances and are generally identified by the
words "may," "expects," "anticipates," "intends," "plans,"
"believes," "seeks," "estimates," "could," "would," and similar
expressions. All forward looking statements are expressly
qualified in their entirety by this cautionary statement.
Because these forward-looking statements are subject to a number of
risks and uncertainties, IntelGenx' actual results could differ
materially from those expressed or implied by these forward-looking
statements. Factors that could cause or contribute to such
differences include, but are not limited to, those discussed under
the heading "Risk Factors" in IntelGenx' annual report on Form
10-K, filed with the United States Securities and Exchange
Commission and available at www.sec.gov, and also filed with
Canadian securities regulatory authorities and www.sedar.com.
IntelGenx assumes no obligation to update any such forward-looking
statements.
Each of the TSX Venture Exchange and OTCQX has neither approved
nor disapproved the contents of this press release. Neither TSX
Venture Exchange nor its Regulation Services Provider (as that term
is defined in the policies of the TSX Venture Exchange) accepts
responsibility for the adequacy or accuracy of this release.
Source: IntelGenx Technologies Corp.
For more information, please contact:
Stephen Kilmer
Investor Relations
(514) 331-7440 ext. 232
stephen@intelgenx.com
Or
Andre Godin, CPA, CA
Executive Vice-President and CFO
IntelGenx Corp.
(514) 331-7440 ext. 203
andre@intelgenx.com
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