RedHill Biopharma and IntelGenx Submit New Drug Application to FDA for RIZAPORT® for Migraines
(Thomson Reuters ONE) -
* RIZAPORT(®) is a proprietary oral thin-film formulation of rizatriptan for
the treatment of acute migraines
* A Prescription Drug User Fee Act (PDUFA) date is expected to be set by the
FDA for the first half of 2018, if the submission is deemed complete and
permits a full review
* RIZAPORT(®) (5mg and 10mg) was granted marketing authorization in Germany
and Luxembourg under the European Decentralized Procedure (DCP) and a
national Marketing Authorization Application (MAA) has been submitted in
Spain
* Commercialization agreements for RIZAPORT(®) were signed with Grupo JUSTE
S.A.Q.F. for Spain and with Pharmatronic Co. for South Korea
* RedHill and IntelGenx continue discussions with additional potential
commercialization partners for RIZAPORT(®) in the U.S., Europe and other
territories
TEL-AVIV, Israel and RALEIGH, N.C., Nov. 01, 2017 (GLOBE NEWSWIRE) -- RedHill
Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) ("RedHill" or the
"Company"), a specialty biopharmaceutical company primarily focused on late
clinical-stage development and commercialization of proprietary, orally-
administered, small molecule drugs for gastrointestinal and inflammatory
diseases and cancer, together with IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT)
("IntelGenx"), 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, today announced that they
have resubmitted the 505(b)(2) New Drug Application (NDA) for RIZAPORT(®) 10mg
to the U.S. Food and Drug Administration (FDA).
RIZAPORT(®) is a proprietary oral thin-film formulation of rizatriptan for the
treatment of acute migraines. RIZAPORT(®) offers an innovative therapeutic
alternative for many migraine patients, primarily patients who suffer from
dysphagia or migraine-related nausea, due to its convenient dosing, facile
intake due to the lack of need for water, and neutral flavor.
Following a first NDA submission to the FDA in March 2013, RedHill and IntelGenx
received a Complete Response Letter (CRL) from the FDA. The questions raised by
the FDA, which triggered the current resubmission, primarily related to third
party chemistry, manufacturing and controls (CMC) and to the packaging and
labeling of the product. The FDA letter raised no questions or deficiencies
relating to RIZAPORT(®)'s safety and bio-equivalence data and did not require
additional clinical trials.
If the RIZAPORT(®) NDA resubmission is deemed complete and permits a full review
by the FDA, a Prescription Drug User Fee Act (PDUFA) date is expected to be set
by the FDA for the first half of 2018.
Reza Fathi, PhD, RedHill's Senior VP Research & Development, said: "We are very
pleased with the resubmission of the U.S. NDA for RIZAPORT(®), which follows the
marketing authorization received for RIZAPORT(®) in Germany and Luxembourg under
the European Decentralized Procedure. Our efforts are focused on commercializing
RIZAPORT(®) through partners in the U.S., Europe and other territories in the
near future, and we are continuing the dialogue with potential partners."
"This resubmission of the RIZAPORT(®) 505(b)(2) NDA is an important milestone
for IntelGenx," commented Dr. Horst G. Zerbe, President and CEO of IntelGenx.
"We look forward to continuing to work with the FDA as we seek to bring this
product to market as a new therapeutic option for the benefit of patients
suffering from migraines."
RIZAPORT(®) was granted marketing authorization in Germany and in Luxembourg on
the basis of the European Decentralized Procedure (DCP). A national Marketing
Authorization Application (MAA) has been submitted for RIZAPORT® in Spain. Under
the European DCP, marketing authorization approval of RIZAPORT(®) in additional
European countries is subject to a separate procedure to obtain additional
national marketing authorizations in each country. A first commercialization
agreement for RIZAPORT(®)was signed with Grupo JUSTE S.A.Q.F. (now Exeltis
Healthcare, S.L.) for Spain, and a second commercialization agreement for
RIZAPORT(®) was signed with Pharmatronic Co. for South Korea.
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 and in Luxembourg in April 2017 under the European Decentralized Procedure.
A New Drug Application for RIZAPORT(®) was resubmitted to the U.S. FDA in
October 2017. RedHill entered into licensing agreements to commercialize
RIZAPORT(® )in Spain (with 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. 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 soluble 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(1) and patients suffering from
dysphagia (difficulty swallowing)(1).
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) is a
specialty 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 promotes three gastrointestinal
products in the U.S.: Donnatal(®), a prescription oral adjunctive drug used in
the treatment of IBS and acute enterocolitis, Esomeprazole Strontium Delayed-
Release Capsules 49.3 mg, a prescription proton pump inhibitor indicated for
adults for the treatment of gastroesophageal reflux disease (GERD) and other
gastrointestinal conditions, and EnteraGam(®), a medical food intended for the
dietary management, under medical supervision, of chronic diarrhea and loose
stools. RedHill's clinical-stage pipeline includes: (i) TALICIA((TM)) (RHB-
105) - an oral combination therapy for the treatment of Helicobacter
pylori infection with successful results from a first Phase III study and an
ongoing confirmatory Phase III study; (ii) RHB-104 - an oral combination therapy
for the treatment of Crohn's disease with an ongoing first Phase III study, a
completed proof-of-concept Phase IIa study for multiple sclerosis, and a planned
pivotal Phase III study for nontuberculous mycobacteria (NTM) infections;
(iii) BEKINDA(®) (RHB-102) - a once-daily oral pill formulation of ondansetron
with successful top-line results from a Phase III study in acute gastroenteritis
and gastritis and successful top-line results from a Phase II study in 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 protease inhibitor, targeting
pancreatic cancer and inflammatory gastrointestinal diseases and
(vii) RIZAPORT(®) (RHB-103) - an oral thin-film formulation of rizatriptan for
acute migraines, with a U.S. NDA resubmitted to the FDA and marketing
authorization received in two EU member states under the European Decentralized
Procedure (DCP). More information about the Company is available
at: www.redhillbio.com.
About IntelGenx:
Established in 2003, IntelGenx is a leading oral drug delivery company primarily
focused on the development and manufacturing of innovative pharmaceutical films
based on its proprietary VersaFilm((TM))technology platform.
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 its clients. More information about the company can be
found at www.intelgenx.com.
(1) 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,"
"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 successfully
market Donnatal(® )and EnteraGam(®), (vi) the Company's ability to establish and
maintain corporate collaborations; (vii) 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; (viii) 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; (ix) the
implementation of the Company's business model, strategic plans for its business
and therapeutic candidates; (x) 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; (xi) parties from whom the Company
licenses its intellectual property defaulting in their obligations to the
Company; and (xii) estimates of the Company's expenses, future revenues capital
requirements and the Company's needs for additional financing; (xiii) the
Company's Expanded Access Program, which allows patients with life-threatening
diseases potential access, subject to regulatory and other approvals, to
RedHill's investigational new drugs that have not yet received regulatory
marketing approval, if a patient suffers an adverse experience using such
investigative drug, potentially adversely affecting the clinical development
program of that investigational product or the Company generally; (xiv)
competitive companies and technologies within the Company's industry. 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 23, 2017. 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: IR contact (U.S.):
Adi Frish Marcy Nanus
Senior VP Business Development & Licensing Senior Vice President
RedHill Biopharma The Trout Group
+972-54-6543-112 +1-646-378-2927
adi(at)redhillbio.com 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: 01.11.2017 - 12:00 Uhr
Sprache: Deutsch
News-ID 566198
Anzahl Zeichen: 15461
contact information:
Town:
Tel-Aviv
Kategorie:
Business News
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"RedHill Biopharma and IntelGenx Submit New Drug Application to FDA for RIZAPORT® for Migraines"
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