RedHill Biopharma and IntelGenx Announce RIZAPORT® Commercialization Term Sheet with Pharmatronic Co. for Korea
September 21 2016 - 8:00AM
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™ (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™ 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™ 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
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