IntelGenx Corp. (TSX-V: IGX) (OTCQX: IGXT) (“IntelGenx”), a leading
oral drug delivery company, today announced the execution of a
definitive licensing, development and supply agreement (the
“Agreement”) with Gensco® Pharma (Gensco®), a specialty
pharmaceutical company focusing on research, development and
marketing of prescription products, for the exclusive
commercialization of RIZAPORT® in the United States.
Upon the anticipated RIZAPORT® approval by the
US Food and Drug Administration (“FDA”), the product will become
the first oral thin film on the market for the treatment of
migraines, and will also be the first commercialized film product
developed and manufactured at IntelGenx’s state-of-the-art
facilities.
“We believe this exciting partnership with
Gensco® offers a tremendous opportunity to commercialize RIZAPORT®
in the world’s largest migraine market1,” said Dr. Horst Zerbe, CEO
of IntelGenx. “We are pleased to work with Gensco® and its seasoned
team of industry veterans with proven track records of launching
and commercializing important therapies using innovative drug
delivery systems.”
“The Gensco® Pharma team is eager to launch
RIZAPORT® as a new therapeutic option for the benefit of patients
suffering from migraines. This innovative therapy aligns with
Gensco®’s mission to provide patients with unique delivery systems
to effectively and safely manage their pain. We look forward
to partnering with the IntelGenx team and executing a highly
successful RIZAPORT® commercial launch,” commented Carlos Alfaras,
President and CEO of Gensco®.
Under the Agreement, Gensco® has been granted
the exclusive right to commercialize the IntelGenx RIZAPORT®
product in the United States. In return, IntelGenx is
entitled to receive royalty payments based on net profits of
RIZAPORT®. IntelGenx is also eligible to receive milestone
payments upon FDA approval and product launch. The agreement also
gives Gensco® exclusivity to develop the market, sell, distribute
and fully commercialize products as a IntelGenx partner for the
People’s Republic of China.
About RIZAPORT®:
RIZAPORT® is a patent protected proprietary oral
thin film formulation of rizatriptan benzoate, a 5-HT1 receptor
agonist and the active drug in Merck & Co.'s Maxalt®.
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. 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)2.
The FDA has assigned a Prescription Drug User
Fee Act (PDUFA) goal date of April 1, 2019, for completion of the
review of the resubmitted New Drug Application for RIZAPORT®.
References:
1 www.globaldata.com/global-migraine-market-set-to-be-worth-8-7-billion-by-2026-2/
2 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 Gensco® Pharma:
Gensco® is a specialty pharmaceutical
manufacturer specializing in development and commercialization of
prescription transdermal products. Gensco®’s capabilities allow for
the quick launch of products into significant niche
markets.
Resources are focused on innovative research,
the development of superior quality medications and unique delivery
systems. Gensco® is an evidence-based solutions company that is
progressively developing products utilizing new technologies that
deliver outcomes to reduce the effects caused by disease or
pathology. More information about Gensco® can be found at
https://genscopharma.com/.
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's highly skilled team provides
comprehensive pharmaceuticals services to pharmaceutical partners,
including R&D, analytical method development, clinical
monitoring, IP and regulatory services. IntelGenx's
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 IntelGenx can be found at
www.intelgenx.com.
Forward Looking Statements:
This document may contain forward-looking
information about IntelGenx's 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's 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's 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's 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 at 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
Intelgenx Technologies (TSXV:IGX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Intelgenx Technologies (TSXV:IGX)
Historical Stock Chart
From Apr 2023 to Apr 2024