RedHill Biopharma Announces Positive Scientific Advice Meeting and European Marketing Application Strategy for RHB-103 (Migraine

RedHill Biopharma Announces Positive Scientific Advice Meeting and European
Marketing Application Strategy for RHB-103 (Migraine)

  *The Company and its co-development partner, IntelGenx Corp., held a
    Scientific Advice meeting with the German pharmaceuticals regulation
    authority (BfArM) and plan to submit a Marketing Authorization Application
    (MAA) to market RHB-103 in Europe during the first half of 2014
  *RHB-103 is a proprietary oral thin film formulation of rizatriptan, the
    active drug in Merck & Co.'s Maxalt MLT^®
  *A U.S. New Drug Application (NDA) for RHB-103 is currently being reviewed
    by the FDA with a PDUFA goal date of February 3, 2014

TEL-AVIV, Israel, Nov. 18, 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, proprietary formulations and combinations of existing
drugs, today reported that the Company and its co-development partner,
IntelGenx Corp. ("IntelGenx"), have recently concluded a positive European
Scientific Advice meeting with the German Federal Institute for Drugs and
Medical Devices (BfArM) regarding RHB-103, a proprietary, oral thin film
formulation of rizatriptan for the treatment of acute migraine.

The Scientific Advice meeting with the BfArM provided sufficient clarity with
regard to the regulatory path. Consequently, RedHill plans to conduct a small
bioavailability study comparing RHB-103 to the European reference product.

RedHill previously conducted a successful bioequivalence trial which
demonstrated the required U.S. Food and Drug Administration (FDA) criteria for
therapeutic bioequivalence between the soluble oral thin film of RHB-103 and
Merck & Co.'s Maxalt MLT^®, the reference drug available in the U.S. In March
2013, following the successful bioequivalence study, RedHill submitted to the
FDA a New Drug Application (NDA) seeking marketing approval of RHB-103. The
FDA is currently conducting a substantive review of the NDA and has assigned a
Prescription Drug User Fee Act (PDUFA) goal date of February 3, 2014.

Following the positive meeting with the BfArM, RedHill plans to complete the
bioavailability study and submit a Marketing Authorization Application (MAA)
for marketing approval of RHB-103 in Europe, with Germany as the reference
member state under the European Mutual Recognition Procedure (MRP), during the
first half of 2014.

"We are encouraged by the positive feedback we received from the German
BfArM", said Dr. Reza Fathi, RedHill's Senior VP R&D. "We now plan to conduct
a relatively short bioavailability study and we expect to file a European
Marketing Authorization Application for RHB-103 during the first half of
2014." Dr. Fathi added; "If approved, RHB-103 will be an attractive new
treatment option for migraine sufferers and physicians, with significant
potential advantages. We are very excited by the upcoming FDA PDUFA date of
February 3, 2014 for the U.S. New Drug Application and by the prospect of
bringing RHB-103 to the European market."

RHB-103 is a proprietary oral thin film formulation of rizatriptan benzoate, a
5-HT[1] 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 $1.6 billion in 2012^1, and the worldwide direct sales of
Merck & Co.'s rizatriptan-based drugs exceeded $600 million in 2012^2.

RHB-103 is based on IntelGenx's proprietary "VersaFilm™" 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. The unique administration method of the RHB-103 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 population^3.

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 product pipeline includes: (i) RHB-103 - an oral
thin film formulation of a leading drug for the treatment of acute migraines,
with a U.S. NDA accepted for review by the FDA in June 2013 and a PDUFA date
of February 3, 2014, (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 first quarter of 2014, (iii) RHB-104 -
a combination antibiotic therapy for the treatment of (a) Crohn's disease,
with a first Phase III trial currently underway, (b) Multiple sclerosis (MS),
with a Phase IIa proof of concept trial currently underway, (c) rheumatoid
arthritis (RA), with plans for a Phase IIa proof of concept trial, and (d)
systemic lupus erythematosus, (iv) RHB-105 - a combination therapy for
Helicobacter pylori infection, with a Phase III trial currently underway, (v)
RHB-101 - a once-daily formulation of a leading congestive heart failure and
high blood pressure drug, and (vi) RHB-106 - an encapsulated formulation for
bowel preparation (laxative) ahead of colonoscopy and other GI procedures. For
more information please visit: www.redhillbio.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) parties from whom the Company licenses its intellectual property
defaulting in their obligations to the Company under their respective
licensing agreements; (x) estimates of the Company's expenses, future revenues
capital requirements and the Company's needs for additional financing; (xi)
competitive companies, technologies and the Company's industry; and (xii) 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.

^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-
relatednausea: results from the AmericanMigrainePrevalence 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
 
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