- RIZAPORT® (5
mg and 10 mg) was granted marketing approval in Germany under the
European Decentralized Procedure (DCP)
- This binding term sheet for
the license of RIZAPORT® in South
Korea follows a recent commercialization agreement for Spain with
Grupo JUSTE S.A.Q.F, who recently filed a national Marketing
Authorization Application (MAA) for RIZAPORT® in
Spain
- RedHill and IntelGenx
expect to re-submit the RIZAPORT® U.S. New
Drug Application (NDA) to the FDA in the first half of 2017 and
subsequently receive a new PDUFA date
TEL-AVIV, Israel, Sept. 21, 2016
(GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL)
(TASE:RDHL) ("RedHill" or the "Company"), a biopharmaceutical
company primarily focused on development and commercialization of
late clinical-stage, proprietary, orally-administered, small
molecule drugs for gastrointestinal and inflammatory diseases and
cancer, together with IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT)
("IntelGenx"), a Canadian drug delivery company focused on oral
drug delivery, today announced that they have entered into a
binding term sheet with Pharmatronic Co. granting Pharmatronic Co.
the exclusive license to commercialize RIZAPORT® in
the Republic of Korea (South Korea). RIZAPORT® is
a proprietary oral thin film formulation of rizatriptan for the
treatment of acute migraines.
Subject to satisfaction of
remaining conditions, the parties will endeavor to enter into a
definitive agreement within 60 days of the execution of the term
sheet.
Pursuant to the signing of a
definitive agreement, RedHill will grant Pharmatronic Co. the
exclusive rights to register and commercialize RIZAPORT® in South
Korea. Under the term sheet, RedHill and IntelGenx are to receive
an upfront payment and will be eligible to receive additional
milestone payments upon achievement of certain predefined
regulatory and commercial targets, as well as tiered royalties.
Financial terms of the term sheet were not disclosed. The initial
term of the definitive agreement is expected to be ten years from
the date of first commercial sale with an automatic renewal of an
additional two years. Commercial launch in South Korea is
estimated to take place in the first quarter of 2019.
Mr. Adi
Frish, RedHill's Senior VP Business Development & Licensing,
said: "We are very pleased to enter into this term sheet
with Pharmatronic Co. This is potentially the second territorial
license for the commercialization of RIZAPORT®,
following the license agreement with Grupo JUSTE for Spain, where a
marketing application for RIZAPORT® has
recently been submitted. We continue to work diligently to maximize
the worldwide potential of this unique migraine drug and are in
discussions with multiple potential commercialization partners.
Pharmatronic Co. holds a growing portfolio of neurology-focused
drugs and is experienced in commercializing migraine products in
South Korea. With its unique dissolvable oral thin film delivery
form and pleasant flavoring, we are confident that
RIZAPORT® should
be a welcomed therapeutic alternative for many migraine patients in
Korea."
RIZAPORT® (5 mg
and 10 mg) was granted marketing authorization by the Federal
Institute for Drugs and Medical Devices of Germany (BfArM) under
the European Decentralized Procedure (DCP), in which Germany served
as the Reference Member State for other European Union (EU)
countries. This authorization was the first national marketing
approval of RIZAPORT® and a
first commercialization agreement was recently signed with Grupo
JUSTE S.A.Q.F for Spain and additional potential territories. A
national Marketing Authorization Application (MAA) for
RIZAPORT® was
recently submitted by Grupo JUSTE S.A.Q.F in Spain under the
European DCP.
RedHill and IntelGenx expect to
re-submit the RIZAPORT® New Drug
Application (NDA) to the FDA in the first half of 2017 and
subsequently receive a new PDUFA (Prescription Drug User Fee Act)
date and are currently in discussions with potential
commercialization partners for the U.S. market.
About
RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) is a
biopharmaceutical company headquartered in Israel, primarily
focused on the development and commercialization of late
clinical-stage, proprietary, orally-administered, small molecule
drugs for the treatment of gastrointestinal and inflammatory
diseases and cancer. RedHill's current pipeline of proprietary
products includes: (i) RHB-105 - an oral combination therapy for the
treatment of Helicobacter
pylori infection with successful results from a first
Phase III study; (ii) RHB-104 - an oral combination therapy for the
treatment of Crohn's disease with an ongoing first Phase III study
and an ongoing proof-of-concept Phase IIa study for multiple
sclerosis; (iii) BEKINDA® (RHB-102) - a
once-daily oral pill formulation of ondansetron with an ongoing
Phase III study for acute gastroenteritis and gastritis and an
ongoing Phase II study for IBS-D; (iv) RHB-106 - an encapsulated bowel preparation licensed
to Salix Pharmaceuticals, Ltd.; (v) YELIVA(TM) (ABC294640) - a
Phase II-stage, orally-administered, first-in-class SK2 selective
inhibitor targeting multiple oncology, inflammatory and
gastrointestinal indications; (vi) MESUPRON - a Phase II-stage first-in-class,
orally-administered uPA inhibitor, targeting gastrointestinal and
other solid tumors; (vii) RP101 - currently subject to an option-to-acquire
by RedHill, RP101 is a Phase II-stage first-in-class,
orally-administered Hsp27 inhibitor, targeting pancreatic and other
gastrointestinal cancers; (viii) RIZAPORT® (RHB-103) - an
oral thin film formulation of rizatriptan for acute migraines, with
a U.S. NDA currently under discussion with the FDA and marketing
authorization received in Germany in October 2015; and
(ix) RHB-101 - a
once-daily oral pill formulation of the cardio drug carvedilol.
About
Pharmatronic. Co:
Pharmatronic Co. is a pharmaceutical company headquartered in
Seoul, Korea and distributing exclusively licensed pharmaceutical
products with innovative sales and marketing know-how. Since
established in 2005, Pharmatronic Co. has focused R&D and
marketing resources on the specialized target field of neurology,
ENT and urology, building a strong image of a leading provider in
the pharmaceutical and healthcare industry.
About
IntelGenx:
IntelGenx is a leading oral drug delivery company focused on the
development and manufacturing of innovative pharmaceutical oral
films based on its proprietary VersaFilm(TM) technology
platform. Established in 2003, the Montreal-based company is
listed on the TSX-V and OTC-QX.
IntelGenx highly skilled team
provides comprehensive pharmaceuticals services to pharmaceutical
partners, including R&D, analytical method development,
clinical monitoring, IP and regulatory services. IntelGenx
state-of-the art manufacturing facility, established for the
VersaFilm(TM)technology
platform, supports lab-scale to pilot and commercial-scale
production, offering full service capabilities to our
clients. 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 research,
manufacturing, 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, approvals and feedback; (iv) the
manufacturing, 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 Company's ability to acquire products
approved for marketing in the U.S. that achieve commercial success
and build its own marketing and commercialization capabilities;
(vii) the interpretation of the properties and characteristics of
the Company's therapeutic candidates and of the results obtained
with its therapeutic candidates in research, preclinical studies or
clinical trials; (viii) the implementation of the Company's
business model, strategic plans for its business and therapeutic
candidates; (ix) 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; (x)
parties from whom the Company licenses its intellectual property
defaulting in their obligations to the Company; (xi) estimates of
the Company's expenses, future revenues capital requirements and
the Company's needs for additional financing; (xii) competitive
companies and technologies within the Company's industry; and
(xiii) 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 Form 20-F filed with the
SEC on February 25, 2016. 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.
Company contact:
Adi Frish
Senior VP Business Development &
Licensing
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
IR contact (U.S.):
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
Mnanus@troutgroup.com
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: RedHill Biopharma Ltd. via Globenewswire
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