RedHill Biopharma Provides 2017 Year-End Business Update
December 05 2017 - 9:30AM
RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL)
(“RedHill” or the “Company”), a specialty biopharmaceutical company
primarily focused on late clinical-stage development and
commercialization of proprietary drugs for gastrointestinal
diseases and cancer, today provided a 2017 year-end summary of its
main activities and key milestones expected in 2018.
- Cost reduction plan. Cash balance1 at the end
of 2017 is expected to be approximately $45 million, with no debt.
A cost reduction plan is in place to gradually reduce the average
quarterly cash burn rate in 2018 to approximately $8.5
million.
- Increasing resource optimization and focus on GI,
including termination of RIZAPORT® license. Given the
Company’s increasing focus on gastrointestinal (GI) diseases and in
particular its two key Phase III GI programs with near-term data
points and blockbuster potential for Crohn’s disease and H. pylori
infection, a notice has been provided to IntelGenx Corp. (TSXV:
IGX; OTCQX: IGXT) that RedHill will terminate, effective January 6,
2018, its co-development and commercialization agreement for the
non-core migraine drug product candidate, RIZAPORT®, for which a
recent Incomplete Response Letter has been received from the
FDA.
- Top-line results from the ongoing Phase III study with
RHB-104 for Crohn’s disease expected mid-2018.
Enrollment of all 331 subjects in the MAP US study has been
completed and the last patient to reach the primary endpoint
assessment (remission at week 26) is expected by May
2018.
- Top-line results from the ongoing confirmatory Phase
III study with TALICIA™ (RHB-105)2 for H. pylori infection are
expected in H2/2018. To date, 136 patients out of a
planned total of 444 subjects have been enrolled. TALICIA™ was
previously granted QIDP fast track designation from
FDA.
- A pivotal Phase III study with RHB-104 for the
treatment of nontuberculous mycobacteria (NTM) infections is
expected to be initiated in H1/2018, subject to additional input
from the FDA. RHB-104 will be assessed as a first-line
treatment of pulmonary NTM disease caused by mycobacterium avium
complex (MAC) infection, for which QIDP fast-track designation was
previously granted by the FDA.
- A single-arm Phase IIa study with YELIVA® (ABC294640)3
for the treatment of cholangiocarcinoma (bile duct cancer) is
expected to be initiated in the coming weeks at Mayo Clinic and MD
Anderson. YELIVA® was granted Orphan Drug
designation by the FDA for the treatment of
cholangiocarcinoma.
- Managed Markets Activity. RedHill is expanding
U.S. managed care access and coverage to its commercial products by
securing multiple agreements with top managed care
organizations.
Dror Ben-Asher, RedHill’s CEO,
said: “With a cost reduction and resource optimization
plan in place for 2018 and 2019, we are focusing on delivering the
two rapidly-approaching Phase III data read-outs with RHB-104 for
Crohn’s disease and TALICIA™ for H. pylori infection, which, if
approved, have blockbuster potential, given the limitations of
available therapies.”
About RedHill Biopharma
Ltd.:RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock
Exchange:RDHL) is a specialty biopharmaceutical company, primarily
focused on the development and commercialization of late
clinical-stage, proprietary drugs for the treatment of
gastrointestinal diseases and cancer. RedHill promotes three
gastrointestinal products in the U.S.: Donnatal® -
a prescription oral adjunctive drug used in the treatment of IBS
and acute enterocolitis; Esomeprazole Strontium
Delayed-Release Capsules 49.3 mg - a prescription proton
pump inhibitor indicated for adults for the treatment of
gastroesophageal reflux disease (GERD) and other gastrointestinal
conditions; and EnteraGam® - a medical food
intended for the dietary management, under medical supervision, of
chronic diarrhea and loose stools. RedHill’s key clinical-stage
development programs include: (i) TALICIA™
(RHB-105) - an oral combination therapy for the treatment
of Helicobacter pylori infection with successful results from a
first Phase III study and an ongoing confirmatory Phase III study;
(ii) RHB-104 - an oral combination therapy for the
treatment of Crohn's disease with an ongoing first Phase III study,
a completed proof-of-concept Phase IIa study for multiple
sclerosis, and a planned pivotal Phase III study for nontuberculous
mycobacteria (NTM) infections; (iii) YELIVA®
(ABC294640) - an orally-administered, first-in-class SK2
selective inhibitor with a planned Phase IIa study for
cholangiocarcinoma; (iv) BEKINDA® (RHB-102) - a
once-daily oral pill formulation of ondansetron with successful
top-line results from a Phase III study in acute gastroenteritis
and gastritis and successful top-line results from a Phase II study
in IBS-D; (v) RHB-106 - an encapsulated bowel
preparation licensed to Salix Pharmaceuticals, Ltd. and (vi)
MESUPRON - a Phase II-stage first-in-class,
orally-administered protease inhibitor, targeting pancreatic cancer
and inflammatory gastrointestinal diseases. More information about
the Company is available at: www.redhillbio.com.
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
successfully market Donnatal® and EnteraGam®; (vi) the Company’s
ability to establish and maintain corporate collaborations; (vii)
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; (viii) the
interpretation of the properties and characteristics of the
Company’s therapeutic candidates and the results obtained with its
therapeutic candidates in research, preclinical studies or clinical
trials; (ix) the implementation of the Company’s business model,
strategic plans for its business and therapeutic candidates; (x)
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; (xi) parties
from whom the Company licenses its intellectual property defaulting
in their obligations to the Company; (xii) estimates of the
Company’s expenses, future revenues capital requirements and needs
for additional financing; (xiii) the effect of patients suffering
adverse experiences using investigative drugs under the Company's
Expanded Access Program; and (xiv) competition from other companies
and technologies within the Company’s industry. 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 23, 2017. All forward-looking statements
included in this press release are made only as of the date of this
press release. The Company assumes no obligation to update any
written or oral forward-looking statement, whether as a result of
new information, future events or otherwise, unless required by
law.
1 Including cash, short-term investments and
non-current bank deposits.
2 TALICIA™ (RHB-105) is an investigational new
drug, not available for commercial distribution.
3 YELIVA® (ABC294640) is an investigational new
drug, not available for commercial distribution.
Company
contact:Adi FrishSenior VP Business Development &
Licensing RedHill Biopharma+972-54-6543-112adi@redhillbio.com |
|
IR contact
(U.S.): Marcy NanusSenior Vice President The Trout
Group+1-646-378-2927Mnanus@troutgroup.com |
Redhill Biopharma (NASDAQ:RDHL)
Historical Stock Chart
From Aug 2024 to Sep 2024
Redhill Biopharma (NASDAQ:RDHL)
Historical Stock Chart
From Sep 2023 to Sep 2024