RedHill Biopharma Submits New Drug Application to U.S. FDA for RHB-103 Anti-Migraine Oral Thin Film

RedHill Biopharma Submits New Drug Application to U.S. FDA for RHB-103
Anti-Migraine Oral Thin Film

TEL-AVIV, Israel, March 27, 2013 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd.
(Nasdaq:RDHL) (TASE:RDHL) (the "Company" or "RedHill"), an emerging Israeli
biopharmaceutical company focused primarily on the development and acquisition
of late clinical-stage, patent-protected, new formulations and combinations of
existing drugs, today announced that the Company and its co-development
partner, IntelGenx Corp. ("IntelGenx"), have submitted a New Drug Application
(NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing
approval of RHB-103, a proprietary, oral thin film formulation of rizatriptan,
a leading drug for the treatment of acute migraine.

The NDA was submitted under a 505(b)(2) regulatory path, following a positive
pre-NDA meeting with the FDA and is supported by a successful bioequivalence
clinical trial that demonstrated the required FDA criteria for therapeutic
equivalence between the soluble oral film of RHB-103 and Merck & Co.'s Maxalt
MLT^®.

RHB-103 is an oral thin film formulation of rizatriptan benzoate, a 5-HT1
agonist and the active drug in Merck & Co.'s Maxalt^® drugs. Rizatriptan is
considered one of the most effective oral triptans - a class of molecules that
constrict blood vessels in the brain in order to relieve swelling and other
migraine symptoms. The worldwide market of triptans was estimated at
approximately $2.1 billion in 2011^1, of which the worldwide direct sales of
Merck & Co.'s rizatriptan-based drugs exceeded $600 million^2.

RHB-103 is based on IntelGenx' proprietary "VersaFilm^TM" technology. The
RHB-103 thin film strip dissolves rapidly in the mouth, leading to the
absorption of the drug through the gastro intestinal track and into the
bloodstream.

"We are very pleased with the submission of the NDA for RHB-103. It is our
first NDA and an important milestone for RedHill and IntelGenx, as it brings
us one step closer to making this attractive thin film rizatriptan drug
available for migraine patients in need," said Elkan Gamzu, RedHill's RHB-103
Product Manager. "RedHill's RHB-103 oral thin film is characterized by rapid
dissolution, ease of use, pleasant flavoring, and the ability to administer
without water, all of which we believe are important for patients who suffer
from migraines."

RedHill further reported on February 25, 2013 of its plan to submit a second
NDA in the fourth quarter of 2013, for the U.S. marketing approval of RHB-102,
a patent protected, oral, extended-release (24 hours) formulation of
ondansetron for the prevention of nausea and vomiting in cancer patients. The
RHB-102 planned NDA submission follows a successful bioavailability trial, as
well as a recent Type B meeting with the FDA.

About RedHill Biopharma Ltd.:

RedHill Biopharma (Nasdaq:RDHL) (TASE:RDHL) is an emerging Israeli
biopharmaceutical company focused primarily on the development and acquisition
of late clinical-stage, patent protected, new formulations and combinations of
existing drugs. The Company's current product pipeline includes: (i) RHB-101 -
a once-daily formulation of a leading congestive heart failure and high blood
pressure drug, planned to be submitted for a Marketing Authorization
Application (MAA) in Europe, (ii) RHB-102 - a once-daily formulation of a
leading chemotherapy and radiotherapy-induced nausea and vomiting prevention
drug, planned for U.S. NDA submission in the fourth quarter of 2013, (iii)
RHB-103 - an oral thin film formulation drug for the treatment of acute
migraine, with U.S. NDA submitted March 2013, (iv) RHB-104 - a combination
therapy for the treatment of Crohn's disease, planned to commence a first
Phase III trial in the second quarter of 2013, as well as Multiple Sclerosis
(MS) Phase IIa proof of concept trial planned to commence in the first quarter
of 2013, (v) RHB-105 - a combination therapy for the treatment of Helicobacter
pylori bacteria causing ulcers, planned to commence a phase II/III trial in
the second quarter of 2013, and (vi) RHB-106 - an encapsulated formulation for
bowel preparation (laxative) ahead of colonoscopy. 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 severe depression, hypertension, erectile
dysfunction, benign prostatic hyperplasia, migraine, insomnia, idiopathic
pulmonary fibrosis, allergies and pain management. 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 not
guarantees of future performance, are based on certain assumptions and the
Company's current and best understanding of the regulatory status 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) estimates of the Company's expenses, future revenues capital requirements
and the Company's needs for additional financing; (x) competitive companies,
technologies and the Company's industry; and (xi) statements as to the impact
of the political and security situation in Israel on the Company's business.
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 From 20-F filed with the SEC on February 19,
2013, and its Reports on Form 6-K. Investors and security holders are urged to
read these documents free of charge on the SEC's web site at
http://www.sec.gov. 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 made by us
or on our behalf as a result of new information, future events or other
factors.

^12011 report by Business Insights

^22012 annual report of Merck & Co., Inc.

CONTACT: PR contact (US):
         Lauren Glaser
         Vice President
         The Trout Group
         +1-646-378-2972
         lglaser@troutgroup.com
        
         Company contact:
         Adi Frish
         Senior VP Business Development & Licensing
         RedHill Biopharma
         +972-54-6543-112
         adi@redhillbio.com
 
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