RedHill Biopharma and IntelGenx Submit Response to FDA CRL for RHB-103 Migraine Oral-Film
March 03 2014 - 8:00AM
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, today
announced, together with IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT)
("IntelGenx"), a Canadian drug delivery company focusing on oral
drug delivery, 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 RHB-103, an oral
thin-film rizatriptan 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 RHB-103's safety and did
not require additional clinical studies. RedHill and IntelGenx
believe that their response to the FDA addresses all the issues
raised in the CRL.
RedHill and IntelGenx will continue working with the FDA on the
continuing review of the RHB-103 NDA, and will provide additional
updates as and when applicable.
About RHB-103
RHB-103 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.
RHB-103 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 RHB-103 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 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.
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.
This press release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995. Such statements may be preceded by the words "intends,"
"may," "will," "plans," "expects," "anticipates," "projects,"
"predicts," "estimates," "aims," "believes," "hopes," "potential"
or similar words. Forward-looking statements are based on certain
assumptions and are subject to various known and unknown risks and
uncertainties, many of which are beyond the Company's control, and
cannot be predicted or quantified and consequently, actual results
may differ materially from those expressed or implied by such
forward-looking statements. Such risks and uncertainties include,
without limitation, risks and uncertainties associated with (i) the
initiation, timing, progress and results of the Company's
preclinical studies, clinical trials, and other therapeutic
candidate development efforts; (ii) the Company's ability to
advance its therapeutic candidates into clinical trials or to
successfully complete its preclinical studies or clinical trials;
(iii) the extent and number of additional studies that the Company
may be required to conduct and the Company's receipt of regulatory
approvals for its therapeutic candidates, and the timing of other
regulatory filings and approvals; (iv) the clinical development,
commercialization, and market acceptance of the Company's
therapeutic candidates; (v) the Company's ability to establish and
maintain corporate collaborations; (vi) the interpretation of the
properties and characteristics of the Company's therapeutic
candidates and of the results obtained with its therapeutic
candidates in preclinical studies or clinical trials; (vii) the
implementation of the Company's business model, strategic plans for
its business and therapeutic candidates; (viii) the scope of
protection the Company is able to establish and maintain for
intellectual property rights covering its therapeutic candidates
and its ability to operate its business without infringing the
intellectual property rights of others; (ix) parties from whom the
Company licenses its intellectual property defaulting in their
obligations to the Company; (x) estimates of the Company's
expenses, future revenues capital requirements and the Company's
needs for additional financing; and (xi) competitive companies,
technologies and the Company's industry. More detailed information
about the Company and the risk factors that may affect the
realization of forward-looking statements is set forth in the
Company's filings with the Securities and Exchange Commission
(SEC), including the Company's Annual Report on Form 20-F filed
with the SEC on February 25, 2014. All forward-looking statements
included in this Press Release are made only as of the date of this
Press Release. We assume no obligation to update any written or
oral forward-looking statement unless required by law.
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: Company contact:
Adi Frish
Senior VP Business Development & Licensing
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
PR contact (U.S.):
Lauren Glaser
Vice President
The Trout Group
+1-646-378-2972
lglaser@troutgroup.com
IntelGenx Technologies (QB) (USOTC:IGXT)
Historical Stock Chart
From Mar 2024 to Apr 2024
IntelGenx Technologies (QB) (USOTC:IGXT)
Historical Stock Chart
From Apr 2023 to Apr 2024