RedHill Biopharma and IntelGenx Announce Definitive Agreement for Commercialization of RIZAPORT® for Migraines with Pharmatronic Co. in South Korea
(Thomson Reuters ONE) -
* RedHill and its co-development partner, IntelGenx Corp. (IntelGenx), have
signed a definitive agreement with Pharmatronic Co., granting an exclusive
license to commercialize the acute migraine drug RIZAPORT(®) in South Korea
* This agreement follows the previously announced commercialization agreement
with Grupo JUSTE S.A.Q.F for Spain, and the subsequent submission of a
national marketing authorization application 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, Dec. 14, 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 the signing of an exclusive
license agreement with Pharmatronic Co. ("Pharmatronic Co.") for the
commercialization of RIZAPORT(® )in the Republic of Korea (South Korea).
RIZAPORT(®) is a proprietary oral thin film formulation of rizatriptan for the
treatment of acute migraines.
Under the terms of the agreement, RedHill granted Pharmatronic Co. the exclusive
rights to register and commercialize RIZAPORT(® )in South Korea. RedHill and
IntelGenx are entitled 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. The initial term
of the definitive agreement with Pharmatronic Co. is for ten years from the date
of first commercial sale and shall automatically renew for an additional two-
year term. 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 pleased to enter into our second commercialization agreement for
RIZAPORT(®) and look forward to building a long-term relationship with
Pharmatronic Co. This agreement for South Korea follows our recent
commercialization agreement with Grupo JUSTE S.A.Q.F for Spain. We continue
working diligently together with our partner IntelGenx to bring this unique
migraine drug to additional markets and expect to re-submit the RIZAPORT(®) NDA
to the FDA in the first half of 2017."
"We are most pleased to enter the Asian market for the first time with
Pharmatronic, a Korean organization committed to customer service
excellence," said Dr. Horst G. Zerbe, President and CEO of IntelGenx. "We will
be working hard with our partners RedHill and Pharmatronic to bring our
innovative product to market for patients in South Korea suffering from
migraines. The execution of two commercialization agreements for RIZAPORT(®) in
less than six months demonstrates our relentless execution of strategy to bring
our innovative products to the global market."
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 for RIZAPORT(®). A first commercialization agreement
was signed with Grupo JUSTE S.A.Q.F (Grupo JUSTE) for Spain and additional
potential territories and, subsequently, a national Marketing Authorization
Application (MAA) for RIZAPORT(®) was submitted by Grupo JUSTE 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 RIZAPORT(®) (RHB-103):
RIZAPORT(®) 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(®).
RIZAPORT(®) 5 mg and 10 mg were approved for marketing in Germany in October
2015 under the European Decentralized Procedure. A New Drug Application for
RIZAPORT(®) was also filed with the U.S. FDA in 2013 and a CRL was received in
2014. RedHill has entered into licensing agreements to commercialize
RIZAPORT(® )in Spain (with Grupo JUSTE S.A.Q.F) and in South Korea (with
Pharmatronic Co.). Rizatriptan is considered to be one of the most effective
oral triptans, a class of molecules that constricts blood vessels in the brain
to relieve swelling and other migraine symptoms. The worldwide annual sales of
triptans were estimated to have exceeded $690 million in 2015(1). RIZAPORT(®) is
based on IntelGenx's proprietary VersaFilm((TM)) technology. It dissolves
rapidly and releases its active ingredient in the mouth, leading to efficient
absorption of the drug through the gastrointestinal tract. The administration
method of the RIZAPORT(®) oral thin film, which does not require the patient to
swallow a pill or consume water, along with its pleasant flavor, presents a
potentially attractive therapeutic alternative for migraine patients,
specifically for patients who suffer from migraine-related nausea, estimated to
be approximately 80% of the total migraine patient population(2) and patients
suffering from dysphagia (difficulty swallowing).
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) is a biopharmaceutical company
headquartered in Israel, primarily focused on 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 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 a completed 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 and (vii) 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.
About Pharmatronic. Co:
Pharmatronic Co. is a privately held pharmaceutical company headquartered in
Seoul, South Korea which distributes exclusively licensed pharmaceutical
products with innovative sales and marketing know-how. Since its establishment
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
as a leading provider in the pharmaceutical and healthcare industry.
About IntelGenx:
IntelGenx is a leading oral drug delivery company primarily 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.
(1) EvaluatePharma WW annual sales report.
(2) Lipton RB, Buse DC, Saiers J, Fanning KM, Serrano D, Reed ML. (2013)
Frequency and burden of headache-related nausea: results from the
American Migraine Prevalence and Prevention (AMPP) study, Headache. 2013
Jan;53(1):93-103.
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,"
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and uncertainties include, without limitation, risks and uncertainties
associated with (i) the initiation, timing, progress and results of the
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other therapeutic candidate development efforts; (ii) the Company's ability to
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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
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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
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and therapeutic candidates; (ix) the scope of protection the Company is able to
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requirements and the Company's needs for additional financing; (xii) competitive
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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: 14.12.2016 - 14:00 Uhr
Sprache: Deutsch
News-ID 512887
Anzahl Zeichen: 14565
contact information:
Town:
Tel-Aviv
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