RedHill Biopharma Receives Notice of Allowance for Two Additional U.S. Patents Covering BEKINDA®
(Thomson Reuters ONE) -
* RedHill received Notices of Allowance from the United States Patent and
Trademark Office (USPTO) for two new patents covering BEKINDA(® )(RHB-102),
expected to be valid until at least 2034, once granted
* BEKINDA(®) is a proprietary, bimodal extended-release, once-daily oral pill
formulation of ondansetron, targeting several gastrointestinal indications
* Top-line results from a Phase III study with BEKINDA(®) 24 mg for acute
gastroenteritis and gastritis (the GUARD study) are expected in the second
quarter of 2017
* A Phase II study with BEKINDA(®) 12 mg for diarrhea-predominant irritable
bowel syndrome (IBS-D) is ongoing, with top-line results expected in the
third quarter of 2017
* RedHill will host an R&D Day and live webcast on BEKINDA(® )on Thursday,
April 27, 2017 in NYC, discussing the product, indications, potential
markets and the ongoing Phase III and II studies for acute gastroenteritis
and IBS-D, respectively
TEL-AVIV, Israel, April 18, 2017 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd.
(NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) ("RedHill" or the "Company"), a
specialty biopharmaceutical company primarily focused on the development and
commercialization of late clinical-stage, proprietary, orally-administered,
small molecule drugs for gastrointestinal and inflammatory diseases and cancer,
today announced that it has received notices of allowance from the United States
Patent and Trademark Office (USPTO) for two new patents covering
BEKINDA(®) (RHB-102)(1). Once granted, the patents are expected to be valid
until at least 2034.
Danielle Abramson, Ph.D., RedHill's Director of Intellectual Property & Research
said: "We are very pleased with the allowance of two additional U.S. patents for
BEKINDA(®). This is an important addition to RedHill's strong IP portfolio, that
will further enhance our protection of BEKINDA(®). We are approaching
significant milestones with BEKINDA(®) in the coming months, with top-line
results from the Phase III study for gastroenteritis and gastritis expected in
the second quarter of 2017 and top-line results from the Phase II for IBS-D
expected in the third quarter of 2017."
The patent applications, entitled 'Antiemetic Extended Release Solid Dosage
Forms' and 'Ondansetron Extended Release Solid Dosage Forms for Treating Either
Nausea, Vomiting or Diarrhea Symptoms', cover claims directed to ondansetron
extended release tablets and methods of treating patients with ondansetron
extended release solid dosage forms. In addition to the two new U.S. patent
applications, the patent portfolio covering BEKINDA(® )includes one U.S. patent,
two pending U.S. patent applications, 17 foreign patents, and over 35 pending
foreign patent applications.
BEKINDA(®) is a proprietary, bimodal extended-release, once-daily oral pill
formulation of ondansetron, targeting several gastrointestinal indications.
BEKINDA(® )is intended to provide patients with relief from nausea and vomiting
symptoms for a full 24-hour period with a single oral tablet.
Top-line results from the Phase III study with BEKINDA(®) 24 mg for acute
gastroenteritis and gastritis (the GUARD study) are expected in the second
quarter of 2017. In February 2017, RedHill announced that the last patient had
completed the treatment course and observation period in the randomized, double-
blind, placebo-controlled GUARD study, which treated 320 adults and children
over the age of 12 in 29 U.S. clinical sites.
A randomized, double-blind, placebo-controlled Phase II study with BEKINDA(®) 12
mg is currently ongoing for the treatment of diarrhea-predominant irritable
bowel syndrome (IBS-D). The Phase II study is evaluating the safety and efficacy
of BEKINDA(®) 12 mg in adults over the age of 18 with IBS-D in 16 clinical sites
in the U.S. Top-line results are expected in the third quarter of 2017.
The Phase III GUARD study and Phase II study with BEKINDA(®) are registered
on www.ClinicalTrials.gov, a web-based service of the U.S. National Institutes
of Health, which provides access to information on publicly and privately
supported clinical studies.
About BEKINDA(®) (RHB-102):
BEKINDA(®) is a proprietary, bimodal extended-release (24 hours) oral pill
formulation of ondansetron, covered by several issued and pending patents. A
Phase III clinical study of BEKINDA(®) 24 mg formulation for acute
gastroenteritis and gastritis (the GUARD study) is ongoing in the U.S., with
patient treatment course and observation period completed and top-line results
expected in the second quarter of 2017. A Phase II study with BEKINDA(® )12 mg
formulation is ongoing in the U.S. for the treatment of diarrhea-predominant
irritable bowel syndrome (IBS-D) with top-line results expected in the third
quarter of 2017.
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 has a U.S. co-promotion agreement
with Concordia for Donnatal(®), a prescription oral adjunctive drug used in the
treatment of IBS and acute enterocolitis, as well as an exclusive license
agreement with Entera Health for 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) 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, a completed proof-of-concept Phase IIa study for multiple
sclerosis and QIDP status for nontuberculous mycobacteria (NTM) infections;
(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 protease
inhibitor, targeting pancreatic cancer 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 two EU member states under the European
Decentralized Procedure (DCP). More information about the Company is available
at: www.redhillbio.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 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)
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.
(1) BEKINDA(®) is an investigational new drug, not available for commercial
distribution.
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: 18.04.2017 - 14:00 Uhr
Sprache: Deutsch
News-ID 536791
Anzahl Zeichen: 11998
contact information:
Town:
Tel-Aviv
Kategorie:
Business News
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"RedHill Biopharma Receives Notice of Allowance for Two Additional U.S. Patents Covering BEKINDA®"
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