-
RHB-104 has been
granted Qualified Infectious Disease Product (QIDP) designation by
the U.S. FDA for the treatment of Nontuberculous Mycobacteria (NTM)
Infection
-
Under FDA's Generating
Antibiotic Incentives Now (GAIN) Act, QIDP designation allows for
Fast-Track status and Priority Review, potentially leading to a
shorter NDA review time by the FDA, and, if approved, an additional
five years of U.S. market exclusivity on top of the standard
exclusivity period
-
NTM infections can
occur throughout the body, although pulmonary infections,
lymphadenitis, and skin and soft tissue infections are the most
common; NTM infections have been increasing worldwide over the past
two decades; Treatment is typically prolonged and requires
multi-drug regimens due to the risk of development of
resistance
-
A first Phase III
clinical study with RHB-104 for the treatment of Crohn's disease
(the MAP US study) is ongoing in the U.S. and additional countries;
Increasing evidence supports the hypothesis that Crohn's disease,
and potentially other autoimmune diseases, are related
to Mycobacterium avium subspecies
paratuberculosis (MAP) infection in susceptible
patients
TEL-AVIV, Israel, Jan. 11, 2017 (GLOBE NEWSWIRE)
-- RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE: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 RHB-104 has been granted Qualified Infectious
Disease Product (QIDP) designation by the U.S. FDA for the
treatment of Nontuberculous Mycobacteria (NTM) infections. The QIDP
designation was granted under the FDA's Generating Antibiotic
Incentives Now (GAIN) Act, which is intended to encourage
development of new antibiotic drugs for the treatment of serious or
life-threatening infections.
The granted QIDP designation allows RedHill to
benefit from Fast-Track status, with an expedited development
pathway for RHB-104 for the treatment of NTM infections, as well as
Priority Review, which provides for a shorter review time by the
FDA of a future potential marketing application. If approved for
the treatment of NTM infections, RHB-104 would also receive an
additional five years of U.S. market exclusivity on top of the
standard exclusivity period.
RHB-104 is a proprietary and potentially
groundbreaking antibiotic combination therapy in oral capsule
formulation, with potent intracellular, anti-mycobacterial and
anti-inflammatory properties.
In light of the QIDP designation, RedHill will
consult with the FDA regarding its RHB-104 development program for
NTM infections.
NTM infections can occur throughout the body,
although pulmonary infections, lymphadenitis, and skin and soft
tissue infections are the most commonly affected areas. There are a
number of risk factors that can increase a person's chances of
acquiring NTM infections, including history of bronchiectasis,
chronic obstructive pulmonary disease, smoking, HIV/AIDS, use of
immunosuppressive drugs and certain genetic conditions, such as
cystic fibrosis and alpha-1 antitrypsin deficiency.
Nontuberculous mycobacteria are ubiquitous
organisms commonly isolated from the environment and identified in
drinking water and soil. Patients suffering from NTM infection are
at increased risk for reinfection1. NTM
infections have been increasing worldwide over the past two
decades2, while
treatment of NTM infection remains difficult and entails multiple
antibiotics and an extended treatment course due to the risk of
development of resistance.
A first Phase III study with RHB-104 for the
treatment of Crohn's disease (the MAP US study) is currently
ongoing in the U.S. and additional countries. The development of
RHB-104 is based on increasing evidence supporting the hypothesis
that Crohn's disease, and potentially other autoimmune diseases,
are related to Mycobacterium avium subspecies
paratuberculosis (MAP) infection in susceptible
patients.
Recently, RedHill also completed a 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 (the CEASE MS study). Top-line final
results from the CEASE MS study suggest meaningful positive safety
and clinical signals upon 24 weeks of treatment with RHB-104 as an
add-on therapy, thereby supporting further clinical
development.
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
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 has also completed a 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 (the CEASE MS study). Top-line final results
from the CEASE MS study suggest meaningful positive safety and
clinical signals upon 24 weeks of treatment with RHB-104 as an
add-on therapy, thereby supporting further clinical development.
RHB-104 was also granted QIDP designation for the treatment of
Nontuberculous Mycobacteria (NTM) infections, allowing for
Fast-Track status and Priority Review, potentially leading to a
shorter NDA review time by FDA, and, if approved, an additional
five years of U.S. market exclusivity.
About RedHill Biopharma
Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE: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. 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 and a
completed 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® (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 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
Germany in October 2015. More information about the Company is
available at: www.redhillbio.com.
1 Falkinham
JO, Environmental sources of nontuberculous
mycobacteria, Clin. Chest Med. 2015, 36, 35-41.
2 Adjemian
J et al., Prevalence of Nontuberculous
Mycobacterial Lung Disease in U.S. Medicare
Beneficiaries, Am J Respir Crit Care Med. 2012 Apr 15;
185(8): 881-886.; Brown-Elliott et
al. Antimicrobial Susceptibility Testing,
Drug Resistance Mechanisms, and Therapy of Infections with
Nontuberculous Mycobacteria, Clin Microbiol Rev. 2012 Jul;
25(3): 545-582
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.
Company contact:
Adi Frish
Senior VP Business Development &
Licensing
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
IR contact (U.S.):
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
Mnanus@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
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