|[November 09, 2012]
RedHill Biopharma Announces Successful Pre-NDA Meeting with FDA Toward a Filing of a U.S. New Drug Application (NDA) for its RHB-103 Anti-Migraine Oral Thin-Film
TEL AVIV, Israel --(Business Wire)--
RedHill Biopharma Ltd. (TASE: RDHL), an Israeli biopharmaceutical
company focusing primarily on development and acquisition of late
clinical-stage, patent-protected, new formulations and combinations of
existing drugs, reported that on November 7th, the Company
and its co-development partner, IntelGenx Corp. (TSX-V: IGX) (OTCQX:
IGXT), concluded a pre-New Drug Application ("pre-NDA") meeting with the
U.S. Food and Drug Administration ("FDA") related to RedHill's RHB-103,
a patent protected, oral thin-film formulation of Rizatriptan (the
active drug in Merck & Co.'s Maxalt-MLT® orally disintegrating tablets).
RHB-103 is based on IntelGenx' proprietary immediate release "VersaFilm"
oral thin-film technology for rapid dissolution.
The purpose of the meeting was to discuss the proposed filing of a U.S.
new drug application ("NDA") following the successful pivotal
bioequivalence study conducted by the Company and IntelGenx with RHB-103
earlier this year.
In view of the positive outcome of the aforementioned pre-NDA meeting
with the FDA, RedHill estimates that an NDA will be filed during the
first quarter of 2013. RedHill and IntelGenx are currently in advanced
preparations of the NDA.
RHB-103 is targeting a significant segment of the migraine market -
namely the family of triptan migraine drugs - estimated at approximately
$2 billion in 2011. The world-wide sales of Merck & Co.'s Rizatriptan
drugs, under their various names, including Maxalt® and
Maxlt-MLT® - the reference drug in the RHB-103 pivotal
bioequivalence clinical study - exceeded $600 million in 2011.
Dror Ben-Asher, RedHill Biopharma's CEO, commented, "We continue
to decisively and diligently execute on the Company's business plan and
are looking forward to filing our first New Drug Application in the U.S.
- RHB-103. I would like to take this opportunity to thank RedHill's R&D
team, and our co-development partners at IntelGenx, for achieving this
important milestone with RHB-103."
About RedHill Biopharma Ltd.:
RedHill Biopharma is an emerging Israeli biopharmaceutical company
focused primarily on development of late clinical-stage, patent
protected, new formulations and combinations of existing drugs. The
Company's current product pipeline includes a once-daily formulation of
a leading congestive heart failure and high blood pressure drug, a
once-daily formulation of a leading oncology support nausea and vomiting
prevention drug, an oral thin-film formulation of Rizatriptan for the
treatment of acute migraine, a combination therapy for the treatment of
Crohn's disease as well as Multiple Sclerosis (MS) disease, and
companion diagnostic test for detection of the MAP bacteria, a
combination therapy for the treatment of resistant H. pylori
bacteria causing ulcers, and an encapsulated formulation for bowel
preparation ahead of certain gastro procedures. The Company's team
includes prominent pharmaceutical experts. For more information please
This Press Release does not constitute an offer or solicitation to
acquire and/or sell the Company's securities or to participate in any
investment in the Company. Statements in this Press Release that are not
historical facts, including the estimated filing date of the NDA, are
forward-looking statements based on current expectations of future
events and are subject to risks and uncertainties that could cause
actual results to differ materially from those expressed or implied by
such statements. All of these forward-looking statements are based on
information currently available to the Company and are subject to risks
and uncertainties that may change at any time, including changes in
regulatory requirements, changes in our understanding of the results of
the meeting with the FDA, and that the preparation time of the NDA may
be longer than anticipated, and, therefore, actual results may differ
materially from those expected. 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.
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