DGAP-News: RedHill Biopharma Ltd. / Key word(s): Patent
RedHill Biopharma Ltd.: RedHill Biopharma Announces Allowance of a Patent in
Japan Supporting RHB-104 for Multiple Sclerosis
20.10.2016 / 12:45
The issuer is solely responsible for the content of this announcement.
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Press Release
RedHill Biopharma Announces Allowance of a Patent in Japan Supporting
RHB-104 for Multiple Sclerosis
- RedHill has received from the Japan Patent Office a Notice of Allowance
for a new patent covering RHB-104 for multiple sclerosis (MS), expected
to be valid until 2032, once granted
- RedHill's robust RHB-104 patent portfolio covering its oral antibiotic
combination therapy includes more than 26 patents in many countries,
including the U.S., Australia, Canada, Japan and multiple European
countries, with additional patent claims being pursued
- Top-line final results expected in the coming weeks from the Phase IIa
proof-of-concept study evaluating RHB-104 in patients treated for
relapsing-remitting multiple sclerosis (the CEASE-MS study)
- 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
- A first Phase III clinical study with RHB-104 for Crohn's disease is
ongoing (the MAP US study), with an independent safety-focused data and
safety monitoring board (DSMB) meeting on track for later this quarter
and a second meeting expected in the second quarter of 2017, including
an interim efficacy analysis and evaluation of an option for an early
stop for success for overwhelming efficacy
TEL-AVIV, Israel, October 20, 2016 RedHill Biopharma Ltd. (NASDAQ: RDHL)
(TASE: RDHL) ("RedHill" or the "Company"), a 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, announced that it
has received from the Japan Patent Office a Notice of Allowance for a new
patent covering RHB-104 for the treatment of multiple sclerosis (MS), which
is expected to be valid until 2032, once granted. This notice follows
RedHill's recent announcement that the counterpart European patent
application was approved by the European Patent Office.
RHB-104 is a proprietary, orally-administered, potentially groundbreaking
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.
RHB-104 is also being evaluated as a treatment for relapsing-remitting
multiple sclerosis (RRMS), with top-line final results from a Phase IIa
proof-of-concept study expected in the coming weeks (the CEASE-MS study).
The Phase IIa CEASE-MS open-label study was initiated following several
successful pre-clinical studies conducted by RedHill and was 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.
RedHill's robust RHB-104 patent portfolio, covering its oral antibiotic
combination therapy, includes more than 26 patents in many countries,
including the U.S., Australia, Canada, Japan and multiple European
countries with additional patent claims being pursued.
A first Phase III study with RHB-104 for the treatment of Crohn's disease
is currently ongoing (the MAP US study). The randomized, double-blind,
placebo-controlled MAP US study is planned to enroll a total of 410
subjects in up to 150 clinical sites in the U.S., Canada, Europe,
Australia, New Zealand and Israel. A safety-focused independent data and
safety monitoring board (DSMB) meeting is on track to take place in the
fourth quarter of 2016. A second independent DSMB meeting is expected in
the second quarter of 2017, after the first 205 patients complete 26 weeks
of study participation. Patient 205 was randomized in August 2016.
The second DSMB meeting in the MAP US study will include safety and interim
efficacy analysis and could potentially provide the opportunity to expedite
the data locking process for the final analysis, once the study is
complete. Importantly, this independent DSMB meeting will evaluate the
option of an early stop for success, according to a pre-specified
statistical significance threshold for analysis requiring overwhelming
efficacy of RHB-104 versus placebo in the primary endpoint.
RedHill recently announced several improvements and enhancements to the
Phase III Crohn's disease program to provide a more comprehensive
assessment of RHB-104's treatment effect and bolster the likelihood of the
study's success even further. No changes are planned to the MAP US Phase
III study's primary endpoint or 90% power. Assuming enrollment of all 410
planned subjects, completion of patient recruitment is expected by the end
of 2017.
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 .
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, orally-administered,
potentially groundbreaking 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
Pharmacia/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 top-line interim
results announced and top-line final results expected in the coming weeks.
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.
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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DGAP-News: RedHill Biopharma Ltd.: RedHill Biopharma Announces Allowance of a Patent in Japan Supporting RHB-104 for Multiple Sclerosis
| Source: EQS Group AG