RedHill Biopharma and IntelGenx Announce Definitive Agreement for Commercialization of RIZAPORT(TM) for...
(Thomson Reuters ONE) -
RedHill Biopharma and IntelGenx Announce Definitive Agreement for
Commercialization of RIZAPORT(TM) for Migraines with Grupo JUSTE in Spain and
Additional Potential Territories
* RedHill and its co-development partner, IntelGenx, have signed a definitive
agreement with Grupo JUSTE granting an exclusive license to commercialize
their acute migraine drug RIZAPORT(TM) in Spain, and a right of first
refusal for additional territories
* Grupo JUSTE is a prominent private Spanish company with over 90 years of
experience in the research, development and commercialization of proprietary
pharmaceutical products, including migraine and other central nervous system
(CNS) drugs in Europe, Latin America and other territories
* RIZAPORT(TM) was recently approved for marketing in Germany under the
European Decentralized Procedure (DCP); RedHill and IntelGenx continue to
work together to secure additional commercialization partners for
RIZAPORT(TM) in the U.S., Europe and other territories
TEL-AVIV, Israel, July 05, 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 inflammatory
and gastrointestinal diseases and cancer, together with IntelGenx Corp.
(TSXV:IGX) (OTCQX:IGXT) ("IntelGenx"), a Canadian drug delivery company focused
on oral drug delivery, today announced the signing of an exclusive license
agreement with Grupo JUSTE S.A.Q.F ("Grupo JUSTE"), for the commercialization of
RIZAPORT(TM) in Spain, and a right of first refusal for additional territories.
RIZAPORT(TM) is a proprietary oral thin film formulation of rizatriptan for the
treatment of acute migraines.
Grupo JUSTE is a prominent private Spanish company with over 90 years of
experience in the research, development and commercialization of proprietary
pharmaceutical products, including migraine and other central nervous system
(CNS) drugs, in Europe, Latin America and other territories.
Under the terms of the agreement, RedHill granted Grupo JUSTE the exclusive
rights to register and commercialize RIZAPORT(TM) in Spain and a right of first
refusal for a predefined term for the territories of Belize, Carribean, Chile,
Colombia, Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras,
Mexico, Nicaragua, Panama, the Middle East and Morocco. RedHill and IntelGenx
are entitled to receive an upfront payment and additional milestone payments
upon the achievement of certain predefined regulatory and commercial targets, as
well as tiered royalties. Financial terms of the agreement were not disclosed.
The initial term of the agreement is for ten years from the date of the first
commercial sale and shall automatically renew for an additional two-year
term. Commercial launch in Spain is expected to take place in the second half of
2017.
"We are delighted to enter into this first commercialization agreement for
RIZAPORT(TM) and look forward to building a long-term relationship with Grupo
JUSTE in support of their efforts to introduce RIZAPORT(TM) in Spain and
potentially other LATAM and Middle Eastern territories," said Adi Frish,
RedHill's Senior VP Business Development & Licensing."We believe that, thanks to
the pleasant flavoring and convenient use of the rapidly dissolving thin-film,
RIZAPORT(TM) could potentially become a preferred therapeutic option for
migraine patients worldwide. We continue working diligently together with
IntelGenx to bring this unique and advantageous drug to additional markets in
the near future."
Inés Juste, President of Grupo JUSTE, added: "We are extremely satisfied to
announce the planned arrival of this new formulation of a leading treatment for
migraine. Our partners, IntelGenx and RedHill possess a deep knowledge in the
pharmaceutical industry including strong leadership in innovative formulations
that improve the compliance and the administration pattern of gold standard
drugs. This agreement should allow Grupo JUSTE to bring this new effective
treatment to migraine patients in Spain and potentially some Latin American and
Middle East countries and to reinforce its presence in Neurology."
The Federal Institute for Drugs and Medical Devices of Germany (BfArM) recently
granted marketing authorization for RIZAPORT(TM) 5 mg and 10 mg 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(TM).
About RIZAPORT(TM) (RHB-103):
RIZAPORT(TM) is a proprietary oral thin film formulation of rizatriptan
benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.'s Maxalt®.
RIZAPORT(TM) 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(TM) was also filed with the U.S. FDA in 2013 and a CRL was received in
2014. 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 20151. RIZAPORT(TM) 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(TM) 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 population2 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 the development and
commercialization of late clinical-stage, proprietary, orally-administered,
small molecule drugs for the treatment of inflammatory and gastrointestinal
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(TM) (RHB-102) - a once-
daily oral pill formulation of ondansetron with an ongoing Phase III study in
the U.S. 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 uPA inhibitor, administered by oral capsule,
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 Hsp27 inhibitor, administered by oral tablet, targeting pancreatic and
other gastrointestinal cancers; (viii) RIZAPORT(TM) (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 Grupo JUSTE:
Grupo JUSTE is a Spanish corporate group with more than 90 years' experience in
research, development and distribution of drugs and active pharmaceutical
ingredients. Its activity is aimed at improving the quality of life of patients,
with the Central Nervous System therapies as one of its main areas of expertise
since 1990 and a core strategic focus for the group.
Grupo JUSTE has two areas of activity: the Pharmaceutical Division, with broad
experience in Central Nervous System, Radiology, Gynaecology and Primary Care;
and Justesa Imagen, a fine-chemicals company committed to the research,
development and production of active pharmaceutical ingredients, with
substantial expertise in contrast media. The group has a significant presence
in all the major world markets, directly or through partnerships with leading
pharmaceutical companies. For more information, please visit:www.grupoJUSTE.com
About IntelGenx:
IntelGenx is a leading drug delivery company focused on the development of
innovative products based on its proprietary oral drug delivery technologies.
Established in 2003, the Montreal-based company, listed on the TSX-V and OTC-QX,
develops innovative oral drug delivery solutions based on its proprietary
platform technologies, VersaFilm(TM), VersaTab(TM) and AdVersa(TM). IntelGenx
has developed a broad and diverse product portfolio addressing unmet market
needs and offering lifecycle management opportunities. Forfivo XL(TM), launched
in 2012, is the first and only FDA approved once-daily bupropion HCl 450 mg dose
in a single tablet for the treatment of major depressive disorder. IntelGenx's
highly skilled team provides comprehensive pharmaceutical services to
pharmaceutical partners, including R&D, clinical monitoring, IP protection,
analytical method development and regulatory services. IntelGenx's 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. For more information on IntelGenx,
visit: 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.
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.
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 GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: RedHill Biopharma Ltd. via GlobeNewswire
[HUG#2025775]
Datum: 05.07.2016 - 15:00 Uhr
Sprache: Deutsch
News-ID 481578
Anzahl Zeichen: 16433
contact information:
Town:
Tel-Aviv
Kategorie:
Business News
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