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8-K - FORM 8-K - IntelGenx Technologies Corp. | form8k.htm |
IntelGenx and RedHill Biopharma Announce
Marketing Approval
of RIZAPORT® for Migraines in
Luxembourg
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The national marketing approval in Luxembourg completes the current approval process of RIZAPORT® under the European Decentralized Procedure (DCP); RIZAPORT® is also approved for marketing in Germany and a national Marketing Authorization Application (MAA) has been submitted in Spain
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RIZAPORT® is a proprietary oral thin film formulation of rizatriptan for the treatment of acute migraines
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Commercialization agreements for RIZAPORT® were signed with Grupo JUSTE S.A.Q.F (now Exeltis Healthcare, S.L.) for Spain and Pharmatronic Co. for South Korea
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RedHill and IntelGenx currently expect to re-submit the RIZAPORT® 505(b)(2) New Drug Application (NDA) to the U.S. Food and Drug Administration (U.S. FDA) in the third quarter of 2017
Saint Laurent, Quebec, April 13, 2017 - IntelGenx Corp. (TSXV: IGX; OTCQX: IGXT) (IntelGenx), 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, together with RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) (RedHill), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced that the Ministry of Health of Luxembourg has granted national marketing authorization for RIZAPORT® (5 mg and 10 mg), a proprietary oral thin film formulation of rizatriptan benzoate for the treatment of acute migraines.
The national marketing authorization was granted in Luxembourg on the basis of the DCP, in which Luxembourg served as the Concerned Member State. The approval in Luxembourg marks the completion of the current marketing approval process for RIZAPORT® under the DCP. This process requires marketing approval in at least two European states, a Reference Member State and a Concerned Member State. RIZAPORT® (5 mg and 10 mg) was previously approved for marketing in Germany, which served as the Reference Member State. Under the DCP, marketing authorization approval of RIZAPORT® in additional European countries is subject to a separate procedure to obtain additional national marketing authorizations in each country.
RIZAPORT® offers an innovative and potentially advantageous therapeutic alternative for many migraine patients, primarily patients who suffer from dysphagia or migraine-related nausea, due to its convenient dosing, facile intake due to the lack of need for water and pleasant flavor.
A first commercialization agreement for RIZAPORT® was signed with Grupo JUSTE S.A.Q.F (now Exeltis Healthcare, S.L.) for Spain and, subsequently, a national MAA for RIZAPORT® was submitted by Grupo JUSTE.
A second commercialization agreement for RIZAPORT® was recently signed with Pharmatronic Co. for South Korea.
IntelGenx and RedHill currently expect to re-submit the RIZAPORT® 505(b)(2) NDA to the U.S. FDA in the third quarter of 2017. The companies are continuing discussions with additional potential commercialization partners for RIZAPORT® in the United States, Europe and other territories.
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 DCP. A NDA for RIZAPORT® was also filed with the U.S. FDA
in 2013 and a Complete response letter was received in 2014. RedHill has entered
into licensing agreements to commercialize RIZAPORT® in Spain (with Grupo JUSTE
S.A.Q.F) and in South Korea (with Pharmatronic Co.). 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 thin film, which does not require
the patient to swallow a pill or consume water, along with its pleasant 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).
References:
1 European Commission Health
and Food Safety Directorate-General, Volume 2A, Procedures for marketing
authorization, Chapter 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 RedHill Biopharma Ltd.:
RedHill Biopharma Ltd.
(NASDAQ: RDHL) (TASE: RDHL) is a specialty biopharmaceutical company
headquartered in Israel, primarily focused on the development and
commercialization of late clinical-stage, proprietary, orally-administered,
small molecule drugs for the treatment of gastrointestinal and inflammatory
diseases and cancer. RedHill has a U.S. co-promotion agreement with Concordia
for Donnatal®, a prescription oral adjunctive drug used in the treatment of IBS
and acute enterocolitis, as well as an exclusive license agreement with Entera
Health for EnteraGam®, a medical food intended for the dietary management, under
medical supervision, of chronic diarrhea and loose stools. RedHills
clinical-stage pipeline includes: (i) RHB-105 - an oral combination therapy for
the treatment of Helicobacter pylori infection with successful results from a
first Phase III study; (ii) RHB-104 - an oral combination therapy for the treatment of Crohn's disease with an ongoing first Phase III
study, a completed proof-of-concept Phase IIa study for multiple sclerosis and
QIDP status for nontuberculous mycobacteria (NTM) infections; (iii) BEKINDA®
(RHB-102) - a once-daily oral pill formulation of ondansetron with an ongoing
Phase III study for acute gastroenteritis and gastritis and an ongoing Phase II
study for IBS-D; (iv) RHB-106 - an encapsulated bowel preparation licensed to
Salix Pharmaceuticals, Ltd.; (v) YELIVA® (ABC294640) - a Phase II-stage,
orally-administered, first-in-class SK2 selective inhibitor targeting multiple
oncology, inflammatory and gastrointestinal indications; (vi) MESUPRON - a Phase
II-stage first-in-class, orally-administered protease inhibitor, targeting
pancreatic cancer and other solid tumors and (vii) RIZAPORT® (RHB-103) - an oral
thin film formulation of rizatriptan for acute migraines, with a U.S. NDA
currently under discussion with the FDA and marketing authorization received in
Germany in October 2015. More information about the Company is available at:
www.redhillbio.com.
About IntelGenx:
IntelGenx is a leading oral drug
delivery company primarily focused on the development and manufacturing of
innovative pharmaceutical oral films based on its proprietary VersaFilmTM
technology platform. Established in 2003, the Montreal-based companys
common shares are listed on the TSX-V and OTCQX.
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 VersaFilmTM 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.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange), nor the OTCQX 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