Saint Laurent, Quebec--(Newsfile Corp. - October 1, 2014) - IntelGenx Corp. (TSXV: IGX) (OTCQX: IGXT) ("IntelGenx"), a Canadian drug
delivery company focused on oral drug delivery, today announced, together with
RedHill Biopharma Ltd. (NASDAQ: RDHL) (TASE: RDHL) ("RedHill"), an Israeli
biopharmaceutical company focused on late clinical-stage drugs for inflammatory
and gastrointestinal diseases, including gastrointestinal cancers, that they
have submitted a Marketing Authorization Application ("MAA") to the German
Federal Institute for Drugs and Medical Devices ("BfArM") seeking European
marketing approval of their oral thin film formulation of rizatriptan for acute
migraines, under the brand name RIZAPORT®. The brand name RIZAPORT® was also
conditionally approved by the U.S. Food and Drug Administration ("FDA") as part
of the New Drug Application ("NDA") review process in the U.S., subject to a
Complete Response Letter ("CRL") received from the FDA in February 2014 and
currently under discussions with the FDA.
The MAA was submitted under the European Mutual Recognition
Procedure (MRP) with Germany as the reference member state. The submission is
supported by several studies, including a recently completed comparative
bioavailability study which successfully established the bioequivalence between
RIZAPORT® and the European reference drug, Maxalt® Lingua,
and follows a positive scientific advice meeting with the BfArM.
RIZAPORT® oral thin film does not require the patient to swallow a
pill or consume water and presents a potentially attractive therapeutic
alternative for many migraine patients, including those who suffer from
migraine-related nausea estimated to be approximately 80% of the total migraine
patient population1.
IntelGenx and RedHill previously conducted a successful
bioavailability study which demonstrated the required FDA criteria for
therapeutic bioequivalence between the RIZAPORT® soluble oral thin
film and the U.S. reference drug, Maxalt-MLT®. Following the
successful bioequivalence study, IntelGenx and RedHill announced in March 2013
the submission to the FDA and acceptance for review of an NDA seeking marketing
approval of the product in the U.S., also under the brand name
RIZAPORT®. Following a CRL received from the FDA in February 2014,
which raised questions primarily related to Chemistry, Manufacturing and
Controls ("CMC"), IntelGenx and RedHill reported that they believe that FDA
approval of the RIZAPORT® NDA is subject to the satisfactory
resolution of the remaining CMC questions, as well as securing a compliant
source of the raw material. Accordingly, the companies continue to work with the
FDA in order to address and resolve all remaining CMC questions and to secure a
compliant source of the raw material.
"We are very pleased with the submission of a European
marketing application for RIZAPORT®, which follows our submission of
a U.S. New Drug Application currently under discussions with the FDA" said
Dr. Elkan Gamzu PhD, RedHill's RIZAPORT® Product
Manager. "This regulatory submission in Europe brings us closer to offering
a new and potentially advantageous therapeutic alternative for patients suffering from migraines, including
those who suffer from migraines with nausea and vomiting. We believe that
RIZAPORT® oral thin film's rapid dissolution, pleasant flavoring and
ease of use from the ability to administer without water, potentially improves
compliance and adherence, and we look forward to making the product available to
patients in Europe."
"From a commercial perspective, obtaining marketing
authorization in Europe would expand the commercialization of
RIZAPORT® into the second largest market of Maxalt®"
said Dr. Horst G. Zerbe, President and CEO of IntelGenx. "Pursuing
development activities in Europe demonstrates our commitment to bring
RIZAPORT® to migraine patients across the world and maximize the
value of this asset."
About RIZAPORT®:
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®. Marketing applications for
RIZAPORT® have been filed both in the U.S. (NDA filed in March
2013) and in Europe (MAA filed in October 2014). Rizatriptan is considered one
of the most effective oral triptans, a class of molecules that constrict blood
vessels in the brain to relieve swelling and other migraine symptoms. The
worldwide annual sales of triptans were estimated to have exceeded $1 billion in
20132.
RIZAPORT® is based on IntelGenx' proprietary
"VersaFilm™" technology. RIZAPORT® dissolves rapidly and
releases its active ingredient in the mouth, leading to an efficient absorption
of the drug through the gastro intestinal tract. The administration method of
the RIZAPORT® oral thin film does not require the patient to swallow
a pill or consume water and presents a potentially attractive therapeutic
alternative for many migraine patients, including those who suffer from
migraine-related nausea estimated to be approximately 80% of the total migraine
patient population3.
About IntelGenx:
IntelGenx is a drug delivery company focused on the development
of oral controlled-release products as well as novel rapidly disintegrating
delivery systems. IntelGenx uses its unique multiple layer delivery system to
provide zero-order release of active drugs in the gastrointestinal tract.
IntelGenx has also developed novel delivery technologies for the rapid delivery
of pharmaceutically active substances in the oral cavity based on its experience
with rapidly disintegrating films. IntelGenx’ development pipeline includes
products for the treatment of indications such as severe depression,
hypertension, erectile dysfunction, migraine, insomnia, CNS indications,
idiopathic pulmonary fibrosis, oncology and pain, as well as animal health
products. More information is available about the company at
www.intelgenx.com.
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ: RDHL) (TASE: RDHL) is an
emerging Israeli biopharmaceutical company focused on the development and
acquisition of late clinical-stage, proprietary drugs for the treatment of inflammatory and
gastrointestinal diseases, including gastrointestinal cancers. RedHill’s current
pipeline of proprietary products includes: (i) RHB-104 - an oral
combination therapy for the treatment of Crohn's disease, with an ongoing Phase
III study; (ii) RHB-105 - an oral combination therapy for the
treatment of Helicobacter pylori infection, with an ongoing Phase III
study; (iii) RHB-102 - a once-daily oral pill formulation of
ondansetron with a Phase III study in the U.S. for acute gastroenteritis and a
planned European marketing application for chemotherapy and radiotherapy-induced
nausea and vomiting (iv) RHB-106 - an encapsulated formulation for
bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v)
MESUPRON® - a Phase II-stage uPA inhibitor,
administered by oral capsule, targeting gastrointestinal and other solid tumor
cancers; (vi) RP101 - currently subject to an option-to-acquire by
RedHill, RP101 is a Phase II-stage Hsp27 inhibitor, administered by oral tablet,
targeting pancreatic and other gastrointestinal cancers; (vii)
RIZAPORT® (formerly RHB-103) - an oral thin
film formulation of rizatriptan for acute migraines with a U.S. NDA currently
under discussions with the FDA and a European marketing application submitted in October 2014; and (viii) RHB-101 - a once-daily oral pill
formulation of the cardio drug carvedilol. For more information please visit
www.redhillbio.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 for the fiscal year ended December 31, 2013, 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.
CONTACT:
Dr. Horst G. Zerbe,
President and CEO
IntelGenx Technologies Corp.
T: +1 514-331-7440 (ext. 201)
F: +1
514-331-0436
horst@intelgenx.com
www.intelgenx.com
____________________
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
2 EvaluatePharma, 2013 WW annual sales by
pharmacological class, 5-HT1B (serotonin) & 5HT1D (serotonin) agonist
3 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
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