- 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™ 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™ 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™ 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™ in Spain, and a right of first refusal for additional territories. RIZAPORT™ 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™ 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™ and look forward
to building a long-term relationship with Grupo JUSTE in support of their efforts to introduce RIZAPORT™ 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™ 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™ 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™.
About RIZAPORT™ (RHB-103):
RIZAPORT™ 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™ 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. 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™ is based
on IntelGenx's proprietary VersaFilm™ 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 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™ (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™ (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™ (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™, VersaTab™ and AdVersa™. IntelGenx has developed
a broad and diverse product portfolio addressing unmet market needs and offering lifecycle management opportunities. Forfivo
XL™, 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™ 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@redhillbio.com IR contact (U.S.): Marcy Nanus Senior Vice President The Trout Group +1-646-378-2927 Mnanus@troutgroup.com
