IntelGenx and RedHill Biopharma Receive Complete Response Letter From FDA for VersaFilm Oral Film Product for Acute Migraines
-- FDA's letter accepted the bioequivalence study and safety information
submitted and requires no additional clinical studies; IntelGenx and
RedHill plan to address remaining issues, primarily related to third
party manufacturing, packaging and labeling, within weeks based on
-- In light of the increased regulatory clarity, IntelGenx and RedHill plan
to rapidly advance ongoing discussions with potential partners for the
commercialization of their Anti-Migraine "VersaFilm(TM)" Oral Film
-- In addition to pursuing marketing approval in the U.S., IntelGenx and
RedHill plan to complete the development program for the European market
and submit a Marketing Authorization Application later this year
SAINT LAURENT, Quebec, Feb. 4, 2014 (GLOBE NEWSWIRE) -- IntelGenx Corp.
(TSXV:IGX) (OTCQX:IGXT) ("IntelGenx"), a Canadian drug delivery company
focusing on oral drug delivery, and RedHill Biopharma Ltd.
(Nasdaq:RDHL) (TASE:RDHL) ("RedHill"), an Israeli biopharmaceutical
company focused on the development and acquisition of late
clinical-stage drugs, today announced that they received a Complete
Response Letter ("CRL") from the U.S. Food and Drug Administration
("FDA") regarding the New Drug Application ("NDA") for their
VersaFilm(TM) Oral Film Product for the treatment of acute migraines.
The VersaFilm(TM) product is a proprietary oral thin film formulation
of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug
in Merck & Co.'s Maxalt(R).
A CRL is issued by the FDA's Center for Drug Evaluation and Research to
inform companies that certain questions and deficiencies remain that
preclude the approval of the application in its present form. The
questions raised by the FDA in the CRL regarding the NDA for the
anti-migraine VersaFilm(TM) product primarily relate to third party
Chemistry, Manufacturing and Controls ("CMC") and to the packaging and
labeling of the product. No questions or deficiencies were raised
relating to the product's safety and the FDA's CRL does not require
additional clinical studies.
While continuing to review the FDA's CRL, IntelGenx and RedHill believe
that they can supply the requested information based on available data.
IntelGenx and RedHill further believe that the majority of issues
raised by the FDA were recently addressed in an amendment submitted by
the companies to the FDA that has yet to be reviewed. The companies
will work with the FDA to address the remaining questions in the CRL
and plan to submit the requested information within a few weeks.
IntelGenx and RedHill have been in active discussions with potential
partners for the commercialization of the product and expect to advance
these discussions rapidly following FDA's CRL, which provides increased
regulatory clarity, indicates that no further clinical trials are
required, and raises no issues regarding to the product's safety.
"We appreciate the thorough review of the product NDA by the FDA. We
remain committed to bringing the product to market as quickly as
possible and will work closely with the FDA to advance the application
and address all questions raised by the FDA," said Rajiv Khosla,
IntelGenx' President and CEO and Dror Ben-Asher, RedHill's CEO in a
joint statement. "We believe that the questions raised by the FDA can
be addressed based on available data, and we plan to work vigorously to
submit our response within a few weeks in order to bring this product
to market as a new therapeutic option for the benefit of patients
suffering from migraines."
In addition to pursuing marketing approval in the U.S., and following a
positive meeting with the German pharmaceuticals regulation authority
"BfArM" in October 2013, IntelGenx and RedHill plan to complete the
development program for the European market and submit a Marketing
Authorization Application for marketing approval of the product in
Europe later this year, with Germany as the reference member state
under the European Mutual Recognition Procedure.
About the VersaFilm(TM) Oral Film Product:
The product is a proprietary oral thin film formulation of rizatriptan
benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.'s
Maxalt(R). 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 $1.6 billion
in 20121, and the worldwide direct sales of Merck & Co.'s
rizatriptan-based drugs exceeded $600 million in 20122.
The product is based on IntelGenx' proprietary "VersaFilm(TM)"
technology. It dissolves rapidly in the mouth, leading to the
absorption of the drug through the gastro intestinal track and into the
bloodstream. The administration method of the 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 -
approximately 80% of the total migraine patient population3.
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 primarily on the development and
acquisition of late clinical-stage, proprietary formulations and
combinations of existing drugs. The Company's current pipeline of
proprietary products includes: (i) RHB-103 - an oral thin film
formulation of rizatriptan for acute migraines (ii) RHB-102 - a
once-daily oral pill formulation of ondansetron for the prevention of
chemotherapy and radiotherapy induced nausea and vomiting (iii) RHB-104
- an oral combination therapy for the treatment of Crohn's disease,
with ongoing Phase III study, (iv) RHB-105 -- an oral combination
therapy for Helicobacter pylori infection, with ongoing phase III
study, (v) RHB-106 - an encapsulated formulation for bowel preparation
and (vi) RHB-101 - a once-daily formulation of 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, 2012, 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.
1 EvaluatePharma, 2013, WW annual sales by pharmacological class,
5-HT1B (serotonin) & 5HT1D (serotonin) agonist
2 2012 annual report of Merck & Co., Inc.
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.
2013Jan;53(1):93-103. doi: 10.1111/j.1526-4610.2012.02292.x. Epub 2012
CONTACT: Dr. Rajiv Khosla,
President and CEO
T: +1 514-331-7440
F: +1 514-331-0436