IntelGenx and RedHill Biopharma Submit Response to FDA CRL for VersaFilm(TM) Product for Migraines
March 03 2014 - 8:05AM
IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) ("IntelGenx"), a Canadian
drug delivery company focusing on oral drug delivery, today
announced, together with RedHill Biopharma Ltd. (Nasdaq:RDHL)
(TASE:RDHL) ("RedHill"), an emerging Israeli biopharmaceutical
company focused primarily on the development and acquisition of
late clinical-stage drugs, that they submitted a response to the
Complete Response Letter ("CRL") of the U.S. Food and Drug
Administration ("FDA") for the New Drug Application ("NDA") for
their VersaFilm™ Oral Film Product for the treatment of acute
migraines.
The companies previously reported on February 4, 2014 that they
received the FDA's CRL which raised questions primarily related to
third party Chemistry, Manufacturing and Controls (CMC) and to the
packaging and labeling of the product. The FDA's CRL did not raise
any questions or deficiencies relating to the anti-migraine
VersaFilm™ product's safety and did not require additional clinical
studies. IntelGenx and RedHill believe that their response to the
FDA addresses all the issues raised in the CRL.
IntelGenx and RedHill will continue working with the FDA on the
continuing review of the anti-migraine VersaFilm™ NDA, and will
provide additional updates as and when applicable.
About the VersaFilm™ 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®. 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 20131.
The product is based on IntelGenx' proprietary "VersaFilm™"
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 population2.
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 primarily on the
development and acquisition of late clinical-stage, proprietary
formulations and combinations of existing drugs for the treatment
of inflammatory and gastrointestinal diseases, including cancer and
related conditions. The Company'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 Helicobacter
pylori infection, with an ongoing phase III study; (iii)
RHB-106 - an encapsulated
formulation for bowel preparation licensed to Salix Pharmaceuticals
Ltd.; (iv) RHB-103 - an oral thin film
formulation of rizatriptan for acute migraines with U.S. NDA under
FDA review; (v) RHB-102 - a
once-daily oral pill formulation of ondansetron for the prevention
of chemotherapy and radiotherapy induced nausea and vomiting and,
(vi) RHB-101 - a once-daily oral
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 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. doi:
10.1111/j.1526-4610.2012.02292.x. Epub 2012 Nov 13
CONTACT: Dr. Rajiv Khosla
President and CEO
IntelGenx Corp.
T: +1 514-331-7440
F: +1 514-331-0436
www.intelgenx.com
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