RedHill Biopharma and IntelGenx Announce RIZAPORT® Commercialization Term Sheet with Pharmatronic Co. for Korea
(Thomson Reuters ONE) -
* 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(at)redhillbio.com
IR contact (U.S.):
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
Mnanus(at)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
Datum: 21.09.2016 - 14:00 Uhr
Sprache: Deutsch
News-ID 496189
Anzahl Zeichen: 12677
contact information:
Town:
Tel-Aviv
Kategorie:
Business News
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"RedHill Biopharma and IntelGenx Announce RIZAPORT® Commercialization Term Sheet with Pharmatronic Co. for Korea"
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