DGAP-News: RedHill Biopharma Ltd. / Key word(s): Agreement
RedHill Biopharma and IntelGenx Announce RIZAPORT(R) Commercialization Term
Sheet with Pharmatronic Co. for Korea
22.09.2016 / 15:00
The issuer is solely responsible for the content of this announcement.
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RedHill Biopharma and IntelGenx Announce RIZAPORT(R) Commercialization Term
Sheet with Pharmatronic Co. for Korea
- RIZAPORT(R) (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(R) in South Korea
follows a recent commercialization agreement for Spain with Grupo JUSTE
S.A.F.Q, who recently filed a national Marketing Authorization
Application (MAA) for RIZAPORT(R) in Spain
- RedHill and IntelGenx expect to re-submit the RIZAPORT(R) 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, September 22, 2016 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. (TSXV: IGX; OTCQX: IGXT) ("IntelGenx"), a Canadian drug
delivery company focused on oral drug delivery, announced that they have
entered into a binding term sheet with Pharmatronic Co. granting
Pharmatronic Co. the exclusive license to commercialize RIZAPORT(R) in the
Republic of Korea (South Korea). RIZAPORT(R) 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(R) 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(R), following the license agreement with
Grupo JUSTE for Spain, where a marketing application for RIZAPORT(R) 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(R) should be a welcomed therapeutic alternative for
many migraine patients in Korea."
RIZAPORT(R) (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(R) 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(R) 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(R) 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/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(R)
(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(R) (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.
<pre>
Company contact: IR & PR contact (Europe)
Adi Frish Anne Hennecke
Senior VP Business Development & Managing Partner
Licensing MC Services AG
RedHill Biopharma +49-211-529252-22
+972-54-6543-112 anne.hennecke@mc-services.eu
adi@redhillbio.com
</pre>
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22.09.2016 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
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504595 22.09.2016
DGAP-News: RedHill Biopharma and IntelGenx Announce RIZAPORT(R) Commercialization Term Sheet with Pharmatronic Co. for Korea
| Source: EQS Group AG