RedHill Biopharma Provides Semi-Annual Business Update
April 09 2018 - 7:00AM
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 business update of its main
activities and key highlights expected in 2018, including two Phase
III readouts.
Key Highlights:
- Top-line results from the ongoing Phase III study with
RHB-104 for Crohn’s disease (MAP US study) are expected in
mid-2018. Enrollment of all 331 subjects in the
study has been completed and the last patient to reach the primary
endpoint assessment (remission at week 26) is expected by early May
2018.
- Top-line results from the ongoing confirmatory Phase
III study with TALICIA®
(RHB-105)1 for H. pylori
infection (ERADICATE Hp 2 study)
are expected in H2/2018. To date, approximately
60% out of a planned total of 444 subjects have been enrolled in
the study. TALICIA® was previously granted QIDP
fast-track designation by the FDA, including an extended market
exclusivity period, if approved.
- Amendment to RHB-106 agreement with Salix
Pharmaceuticals. RedHill and Salix recently amended their
2014 worldwide license agreement relating to the RHB-106
encapsulated bowel cleanser, as well as additional related rights.
The amendment clarifies the development efforts to be used by
Salix, as well as provides for enhanced involvement by RedHill in
certain intellectual property matters. In addition, the parties
have agreed to increase the lower end of the range of royalty
payments to be paid to RedHill on net sales from low single digits
to high single digits, such that the potential royalties now range
from high single digits up to low double digits. Milestone payments
remain unchanged.
- Expected continued quarterly revenue growth.
Net revenues in the fourth quarter of 2017 were $2 million, an
increase of 31% over the third quarter of 2017. RedHill expects
continued quarter over quarter net revenue growth. RedHill’s
sales force of approximately 40 sales representatives is calling on
thousands of gastroenterologists across the U.S.
- Continued cost reduction in 2018. Cash to be
used in operating activities is expected to continue to gradually
decrease on average to approximately $8.5 million per quarter
during 2018. RedHill’s cash position was approximately $46 million
at the end of 2017, with no debt.
Additional Updates:
- First five patients enrolled in the
single-arm Phase IIa study with YELIVA®
(ABC294640) for the treatment of
cholangiocarcinoma (bile duct cancer); Enrollment is
expected to be completed by the end of 2018. The Phase IIa
study was recently initiated at Mayo Clinic major campuses in
Arizona and Minnesota, University of Texas MD Anderson Cancer
Center and the Huntsman Cancer Institute, University of Utah
Health, and is planned to enroll up to 39 patients. YELIVA®
was granted Orphan Drug designation by the FDA for the treatment of
cholangiocarcinoma.
- Ongoing discussions with the FDA on planned Phase III
development programs for BEKINDA®
(RHB-102) for acute gastroenteritis and for
IBS-D. Following the positive results of
the Phase III study with BEKINDA® 24 mg for acute gastroenteritis
(GUARD study) and guidance provided by the FDA, RedHill is
currently in discussions with the FDA on the design of a
confirmatory Phase III study to support a potential New Drug
Application (NDA). Following positive results of the Phase II study
with BEKINDA® 12 mg for IBS-D, RedHill plans to meet with the FDA
in the second quarter of 2018 to discuss the design for one or two
pivotal Phase III studies.
- A pivotal Phase III study with RHB-104 for the
treatment of nontuberculous mycobacteria (NTM) infections (QIDP
fast-track designation, including an extended
market exclusivity period, if approved) is
expected to be initiated in H2/2018, subject to completion of a
supportive non-clinical program and additional input from the
FDA. RHB-104 is planned to be assessed as a
first-line treatment of NTM disease caused by mycobacterium
avium complex (MAC) infection.
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
commercializes and 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) for the treatment of
Helicobacter pylori infection with an ongoing confirmatory Phase
III study and positive results from a first Phase III study; (ii)
RHB-104 with an ongoing first Phase III study for
Crohn's disease and a planned pivotal Phase III study for
nontuberculous mycobacteria (NTM) infections; (iii)
BEKINDA® (RHB-102) with positive
results from a Phase III study for acute gastroenteritis and
gastritis and positive results from a Phase II study for IBS-D;
(iv) YELIVA® (ABC294640), a first-in-class SK2
selective inhibitor, targeting multiple oncology, inflammatory and
gastrointestinal indications, with an ongoing Phase IIa study for
cholangiocarcinoma; (v) RHB-106, an encapsulated
bowel preparation licensed to Salix Pharmaceuticals, Ltd. and (vi)
RHB-107 (formerly MESUPRON), a Phase II-stage
first-in-class, serine protease inhibitor, targeting 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 promote Donnatal® and Esomeprazole Strontium
Delayed-Release Capsules 49.3 mg and commercialize 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 22, 2018. 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.
Company contact:Adi FrishSenior VP Business
Development & Licensing RedHill
Biopharma+972-54-6543-112adi@redhillbio.com
_____________________________
1 TALICIA® (RHB-105), YELIVA® (ABC294640) and BEKINDA® are
investigational new drugs, not available for commercial
distribution.
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