RedHill Biopharma Announces Positive FDA Meeting on RHB-105 Path to Approval and Planned Confirmatory Phase III Study for H. pylori Infection
(Thomson Reuters ONE) -
* The FDA has confirmed, subject to final minutes of the meeting, the planned
two-arm, randomized, double-blind, active comparator design of the
confirmatory Phase III study with RHB-105 for the treatment of H.
pylori infection, expected to be initiated in the second half of 2016
* Based on FDA feedback, and subject to successful completion, the planned
confirmatory Phase III study, along with the successfully completed first
Phase III study and data from a supportive PK program, are expected to
support a U.S. New Drug Application (NDA) for RHB-105
* The first Phase III study with RHB-105 successfully demonstrated 89.4%
efficacy in eradicating H. pylori infection with RHB-105 (p<0.001),
supporting the potential superior efficacy of RHB-105 over current standard-
of-care (SoC) therapies
* RHB-105 has received FDA QIDP designation under the GAIN Act, including
Fast-Track development, Priority Review and extended market exclusivity for
a total of eight years
* With H. pylori infection estimated to affect over half of the adult
population worldwide and 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
* RHB-105 is one of RedHill's three ongoing Phase III GI programs in the U.S.,
along with RHB-104 for Crohn's disease, with Phase III interim DSMB analysis
expected in the second half of 2016, and BEKINDA(TM) for gastroenteritis,
with Phase III top-line results also expected in the second half of 2016
TEL-AVIV, Israel, April 18, 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 inflammatory
and gastrointestinal diseases, including cancer, today announced that it has
concluded a positive Type B Meeting with the U.S. Food and Drug Administration
(FDA) regarding the path to marketing approval of RHB-105 and the planned
confirmatory Phase III study. RHB-105 is a proprietary, fixed-dose, oral
combination therapy for the eradication of H. pylori infection.
"We are very pleased with the outcome of the FDA meeting and would like to thank
the Agency for its constructive feedback," said Gilead Raday, Chief Operating
Officer. "The FDA meeting provided a pathway for potential marketing approval of
RHB-105 in the U.S. We plan to initiate the RHB-105 confirmatory Phase III study
discussed with the FDA during the second half of 2016 and hope to bring this new
potential blockbuster drug to the market as soon as possible as a best-in-class,
first-line therapy for eradication of H. pylori."
RedHill met with the FDA to discuss the successful results of the recently
completed first Phase III study with RHB-105 (the ERADICATE Hp study) and the
proposed design of the confirmatory Phase III study for the treatment of H.
pylori infection. As a result of the productive and supportive feedback received
from the FDA, RedHill intends, subject to finalization of the FDA meeting
minutes, to complete the design of the planned confirmatory Phase III
randomized, double-blind, active comparator, two-arm clinical study, comparing
RHB-105 against a high dose amoxicillin and omeprazole regimen.
As per FDA recommendation, RedHill will complete a supportive pharmacokinetic
(PK) program prior to initiating the confirmatory Phase III study in the second
half of 2016. Subject to a successful outcome, the confirmatory Phase III study
and supportive PK program are expected to complete the clinical package required
for a U.S. New Drug Application (NDA) for RHB-105.
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 over half of the adult
population worldwide. 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%1. 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 eradication2.
The ERADICATE Hp first Phase III study with RHB-105 successfully met its
protocol-defined primary endpoint of superiority over historical SoC eradication
rate levels of 70%, with high statistical significance (p<0.001). The final
results demonstrated 89.4% efficacy in eradicating H. pylori infection with RHB-
105. Subsequent open-label treatment of patients in the placebo arm with SoC
therapy for persistent H. pylori infection demonstrated a 63% eradication rate
with SoC, further supporting the potential superior efficacy of RHB-105 over
SoC. RHB-105 was also shown to be safe and well-tolerated.
RHB-105 has been granted Qualifying Infectious Disease Product (QIDP)
designation by the FDA, providing a Fast-Track development pathway, as well as
Priority Review status, potentially leading to a shorter review time by the FDA
of an NDA, 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 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. in the
second half of 2016. 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
Priority Review status, potentially leading to a shorter review time by the FDA
of an NDA, 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: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 inflammatory and gastrointestinal
diseases, including 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 a Phase II study for IBS-D;
(iv) RHB-106 - an encapsulated bowel preparation licensed to Salix
Pharmaceuticals, Ltd.; (v) YELIVA(TM) (ABC294640) - an orally-administered
first-in-class SK2 selective inhibitor targeting multiple oncology, inflammatory
and gastrointestinal indications with a Phase I/II study initiated for
refractory/relapsed diffuse large B-cell lymphoma (DLBCL); (vi) MESUPRON® - 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.
1 Malfertheiner P. et al. Management of Helicobacter pylori infection - the
Maastricht IV/ Florence Consensus Report, Gut 2012;61:646-664.
2 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.
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 GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: RedHill Biopharma Ltd. via GlobeNewswire
[HUG#2004371]
Datum: 18.04.2016 - 14:00 Uhr
Sprache: Deutsch
News-ID 464608
Anzahl Zeichen: 16052
contact information:
Town:
Tel-Aviv
Kategorie:
Business News
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