RedHill Biopharma Announces Approval of a European Patent Supporting RHB-104 for Multiple Sclerosis
(Thomson Reuters ONE) -
* RedHill has received from the European Patent Office a Notice of Intention
to Grant a new patent covering RHB-104 for multiple sclerosis (MS), expected
to be valid until 2032, once granted
* A Phase IIa proof-of-concept study evaluating RHB-104 in patients treated
for relapsing-remitting multiple sclerosis is ongoing (the CEASE-MS study),
with top-line final results expected in the fourth quarter of 2016
* Encouraging interim results from the Phase IIa CEASE-MS study, after
completion of the 24-week treatment period with RHB-104 as an add-on therapy
to interferon beta-1a, demonstrated positive safety and efficacy signals
that support further clinical development
* 2016 U.S. and worldwide sales of MS therapies are estimated to exceed $12
billion and $18 billion, respectively
* RHB-104 is also undergoing a first Phase III clinical study for Crohn's
disease (the MAP US study), with over 200 patients enrolled to date and
interim DSMB analysis on track for the fourth quarter of 2016
TEL-AVIV, Israel, Aug. 29, 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
gastrointestinal and inflammatory diseases and cancer, today announced that it
has received from the European Patent Office a Notice of Intention to Grant for
a new patent covering the use of RHB-104 in the treatment of multiple sclerosis
(MS). Upon grant by the European Patent Office, the patent can be officially
validated in up to 38 European countries.
RHB-104 is a proprietary and potentially groundbreaking oral antibiotic
combination therapy, with potent intracellular, anti-mycobacterial and anti-
inflammatory properties. A first Phase III study with RHB-104 for the treatment
of Crohn's disease is currently ongoing, as well as a Phase IIa proof-of-concept
study for the treatment of MS.
"RHB-104 is a multifaceted drug that, in addition to bactericidal properties
against intracellular infections, has potentially distinct mechanisms of action
that include both anti-inflammation and neuroprotection. This new European
patent is an important addition to RedHill's already robust patent portfolio
covering RHB-104 and we continue to pursue additional patent claims for this
potentially groundbreaking therapy," stated Danielle Abramson, Ph.D., RedHill's
Director of Intellectual Property & Research. "We are very pleased with the
progress achieved with the RHB-104 development programs for Crohn's disease and
multiple sclerosis and look forward to several important upcoming potential
milestones. Interim results from the Phase IIa proof-of-concept study with RHB-
104 for relapsing-remitting multiple sclerosis were encouraging, demonstrating
positive safety and efficacy signals and we are expecting top-line final results
from this study during the fourth quarter of 2016. A DSMB analysis in the Phase
III study with RHB-104 for Crohn's disease is also expected in the fourth
quarter."
Patents covering the antibiotic combination therapy, including the RHB-104
formulation and uses, have been granted in over 25 countries, including the
U.S., Australia, Canada, Japan and multiple European countries. This new allowed
patent application further expands RedHill's worldwide patent portfolio covering
the use of RHB-104 for the treatment of multiple sclerosis and is expected to be
valid until 2032, once granted. Additional U.S. and foreign patent applications
are pending, covering the use of RHB-104 for the treatment of multiple
sclerosis, with recent patent allowances in a number of territories.
RHB-104 is being evaluated as a treatment for relapsing-remitting multiple
sclerosis (RRMS), with an open-label Phase IIa proof-of-concept clinical study
currently ongoing in Israel (the CEASE-MS study). The Phase IIa CEASE-MS study
was initiated following several successful pre-clinical studies conducted by
RedHill and is designed to evaluate RHB-104 as an add-on therapy to interferon
beta-1a in patients treated for RRMS. Patients enrolled in the study received
24 weeks of treatment with RHB-104 as an add-on therapy to interferon beta-1a
and were then evaluated for an additional 24-week follow-up period during which
they were treated with interferon beta-1a alone. Top-line interim results
announced in March 2016, after completion of the 24-week treatment period,
demonstrated positive safety and efficacy signals, including an encouraging
relapse-free rate, Expanded Disability Status Scale (EDSS) scores and MRI
results, which support further clinical development. Top-line final results from
the CEASE-MS study are expected in the fourth quarter of 2016.
RHB-104 is also undergoing a first Phase III study for Crohn's disease in the
U.S., Canada, Israel, Australia and Europe (the MAP US study). With over 200
patients of the planned total of 270 enrolled to date in the ongoing randomized,
double-blind, placebo-controlled MAP US study, interim data and safety
monitoring board (DSMB) analysis is expected in the fourth quarter of 2016.
RedHill is currently reviewing a possible amendment to the Phase III MAP US
study protocol intended to further enhance the overall robustness of the study,
provide a more precise assessment of RHB-104's treatment effect, collect
additional endoscopic mucosal healing data, further evaluate the Crohn's disease
population enrolled and address retention and early terminations. The Company
expects to provide further details in the coming weeks, once plans are
finalized.
The MAP US Phase III study and the CEASE-MS Phase IIa study 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 Multiple Sclerosis:
Multiple sclerosis (MS) is a chronic inflammatory, demyelinating disease of the
central nervous system with an unknown etiology, believed to be multifactorial.
A dysfunctional immune system in MS patients causes recurrent inflammatory
attacks on the central nervous system (CNS), leading to neurological disability.
Diffuse inflammatory and demyelinating lesions, also known as plaques, are the
main pathological finding in MS neural tissue. The lesions are primarily found
in the spinal cord, optic nerves, brainstem and periventricular white matter.
The symptoms of MS are dictated by the location of the lesions within the CNS.
Geographic variation in MS distribution, which cannot be solely explained by
population genetics, supports the notion that environmental factors also hold
etiological importance. There is currently no known cure for MS and available
treatments are mainly intended to manage or prevent relapses or reduce symptoms.
In 2015, there were estimated to be over 900,000 diagnosed patients with MS
worldwide. Approximately 85% of MS patients initially exhibit relapse-remitting
disease (RRMS). The 2016 U.S. and worldwide sales of MS therapies are estimated
to exceed $12 billion and $18 billion, respectively(1).
About RHB-104:
Currently in a first Phase III study for the treatment of Crohn's disease (the
MAP US study), RHB-104 is a proprietary and potentially groundbreaking oral
antibiotic combination therapy, with potent intracellular, anti-mycobacterial
and anti-inflammatory properties. RHB-104 is based on increasing evidence
supporting the hypothesis that Crohn's disease is caused by Mycobacterium avium
subspecies paratuberculosis (MAP) infection in susceptible patients. Clinical
trials conducted with earlier formulations of RHB-104 include an Australian
Phase III study conducted by Pfizer. RedHill has conducted several supportive
studies with the current formulation of RHB-104 and a long-term population
pharmacokinetic (pop-PK) study is ongoing as part of the Phase III MAP US study.
RHB-104 is covered by several issued and pending patents. RedHill is also
conducting the CEASE-MS Phase IIa, proof-of-concept clinical study, evaluating
RHB-104 as an add-on therapy to interferon beta-1a in patients treated for
relapsing-remitting multiple sclerosis (RRMS), with encouraging top-line interim
results announced in March 2016.
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 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(®)(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(®) (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.
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) GlobalData PharmaPoint report, August 2015.
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: 29.08.2016 - 14:00 Uhr
Sprache: Deutsch
News-ID 491536
Anzahl Zeichen: 16132
contact information:
Town:
Tel-Aviv
Kategorie:
Business News
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