DGAP-News: RedHill Biopharma Ltd. / Key word(s): Patent
RedHill Biopharma Ltd.: RedHill Biopharma Receives Additional U.S. Patent
Covering RHB-105 Ahead of Confirmatory Phase III Study for H. pylori
Infection
25.07.2016 / 10:00
The issuer is solely responsible for the content of this announcement.
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Press Release
RedHill Biopharma Receives Additional U.S. Patent Covering RHB-105 Ahead of
Confirmatory Phase III Study for H. pylori Infection
- RedHill has received a Notice of Allowance for an additional U.S.
patent covering RHB-105, expected to be valid until 2034 once granted
- The planned confirmatory Phase III study with RHB-105 for the treatment
of H. pylori infection, if successful, is expected to support a U.S.
New Drug Application (NDA)
- The first Phase III study with RHB-105 successfully demonstrated 89.4%
efficacy in eradicating H. pylori infection (p< 0.001), supporting the
potential superior efficacy of RHB-105 over current standard-of-care
(SoC) therapies
- RHB-105 was granted FDA QIDP designation under the GAIN Act, including
Fast-Track development, NDA Priority Review and extended U.S. market
exclusivity, for a total of eight years
- H. pylori bacterial infection is estimated to affect half of the adult
population worldwide and is a major cause of chronic gastritis, peptic
ulcer disease, gastric cancer and mucosa-associated lymphoid tissue
(MALT) lymphoma
- With increasing failure rates of SoC therapies due to antibiotic
resistance, the 2015 global and U.S. market potential for H. pylori
eradication therapies are estimated at approximately $4.83 billion and
$1.45 billion, respectively
TEL-AVIV, Israel, July 25, 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
inflammatory and gastrointestinal diseases and cancer, announced that
it has received a Notice of Allowance from the United States Patent and
Trademark Office (USPTO) for a new patent covering RHB-105, a proprietary,
fixed-dose, oral combination therapy for the eradication of H. pylori
infection.
The patent application, entitled "Pharmaceutical Compositions For The
Treatment Of Helicobacter Pylori" expands RedHill's patent portfolio
covering RHB-105 and is expected to be valid until 2034, once granted. The
Company is currently prosecuting additional U.S. and international patent
applications covering RHB-105.
"The grant of this new patent is an important addition to RedHill's
expanding IP portfolio covering RHB-105. On top of its extensive patent
estate, RHB-105 was granted FDA QIDP designation under the Gain Act,
providing for a total of 8 years of U.S. market exclusivity," said Danielle
Abramson, Ph.D., RedHill's Director of Intellectual Property & Research.
"We are making good progress with preparations for the confirmatory Phase
III study with RHB-105 for eradication of H. pylori, which follows the
successful first Phase III study with RHB-105 and a positive meeting with
the FDA regarding the path to marketing approval."
H. pylori bacterial infection is a major cause of chronic gastritis, peptic
ulcer disease, gastric cancer and mucosa-associated lymphoid tissue (MALT)
lymphoma. H. pylori infection is estimated to affect half of the adult
population worldwide[1]. The growing resistance of the H. pylori bacteria
to metronidazole and clarithromycin has resulted in increasing failure
rates of current standard-of-care therapies (SoC) for H. pylori
eradication, reaching an estimated 30%[2]. Despite the strong unmet medical
need, no new drug has been approved by the FDA for this indication in over
a decade. The 2015 U.S. and global market potential for H. pylori
eradication therapies, at current branded prices, were estimated at
approximately $1.45 billion and $4.83 billion, respectively, and could
potentially grow with increasing awareness of the health risks associated
with H. pylori infection and the
benefits of its eradication[3].
RedHill announced in April 2016 that it had concluded a positive Type B
Meeting with the U.S. Food and Drug Administration (FDA) regarding the path
to U.S. marketing approval of RHB-105 and the planned confirmatory Phase
III study. As a result of the productive and supportive feedback received
from the FDA, RedHill is preparing for a confirmatory Phase III randomized,
double-blind, active comparator, two-arm clinical study, comparing RHB-105
against a high dose amoxicillin and omeprazole regimen.
Subject to a successful outcome, the confirmatory Phase III study, and the
supportive PK program to be completed prior to its initiation, are expected
to complete the clinical package required for a U.S. New Drug Application
(NDA) for RHB-105.
RHB-105 was previously granted Qualifying Infectious Disease Product (QIDP)
designation by the FDA, providing a Fast-Track development pathway, as well
as NDA Priority Review status, potentially leading to a shorter NDA review
time by the FDA, if filed. If approved, RHB-105 will also receive an
additional five years of U.S. market exclusivity, in addition to the
standard exclusivity period, for a total of 8 years of U.S. market
exclusivity.
With RHB-105, RedHill is pursuing an indication of first-line treatment of
H. pylori infection, regardless of ulcer status, a significantly broader
indication than current standard treatments for H. pylori, which are
typically indicated only for patients with active or recent history of
duodenal ulcer disease. If approved, RHB-105 may be the first H. pylori
eradication therapy to target this broader indication, which would
significantly expand the potential patient population for this drug
candidate.
About RHB-105:
RHB-105 is a new and proprietary fixed-dose oral combination therapy of two
antibiotics and a proton pump inhibitor (PPI) in an all-in-one oral capsule
with a planned indication for the treatment of H. pylori infection. H.
pylori bacterial infection is a major cause of chronic gastritis, peptic
ulcer disease, gastric cancer and mucosa-associated lymphoid tissue (MALT)
lymphoma. A first Phase III study with RHB-105 was completed in the U.S.
with positive results (the ERADICATE Hp study). The study demonstrated an
overall success rate of 89.4% in eradicating H. pylori, and met its
protocol-defined primary endpoint of superiority in eradication of H.
pylori infection over historical standard of care efficacy levels of 70%,
with high statistical significance (p< 0.001). A confirmatory Phase III
study is planned to be initiated in the U.S. Additional studies may be
required, subject to FDA feedback. RHB-105 has been granted Qualifying
Infectious Disease Product (QIDP) designation by the FDA, providing a Fast-
Track development pathway, as well as NDA Priority Review status,
potentially leading to a shorter NDA review time by the FDA, if filed. If
approved, RHB-105 will also receive an additional five years of
exclusivity, in addition to the standard exclusivity period, for a total of
8 years of U.S. market exclusivity.
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 inflammatory and gastrointestinal
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(TM)
(RHB-102) - a once-daily oral pill formulation of ondansetron with an
ongoing Phase III study in the U.S. 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(R) - a Phase II-stage first-in-
class uPA inhibitor, administered by oral capsule, 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
Hsp27 inhibitor, administered by oral tablet, targeting pancreatic and
other gastrointestinal cancers; (viii) RIZAPORT(TM) (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 contact (U.S.):
Adi Frish Marcy Nanus
Senior VP Business Development & Senior Vice President
Licensing The Trout Group
RedHill Biopharma +1-646-378-2927
+972-54-6543-112 Mnanus@troutgroup.com
adi@redhillbio.com
</pre>
[1] World Gastroenterology Organization Global Guidelines - Helicobacter
pylori in developing countries, August 2010.
[2] Malfertheiner P. et al. Management of Helicobacter pylori infection -
the Maastricht IV/ Florence Consensus Report, Gut 2012;61:646-664.
[3] Jerry Rosenblatt, Ph.D., a member of RedHill's Advisory Board and
Partner at Foster Rosenblatt, RedHill Biopharma press release: RedHill
Biopharma's Investor Webcast Forum Provides Update on the RHB-105 Phase III
Program and Potential H. Pylori Eradication Market, May 18, 2015.
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485373 25.07.2016
DGAP-News: RedHill Biopharma Ltd.: RedHill Biopharma Receives Additional U.S. Patent Covering RHB-105 Ahead of Confirmatory Phase III Study for H. pylori Infection
| Source: EQS Group AG