DGAP-News: RedHill Biopharma Announces Research Collaboration with NIH for Potential Ebola Treatment

DGAP-News: RedHill Biopharma Ltd. / Key word(s): Agreement
RedHill Biopharma Announces Research Collaboration with NIH for Potential
Ebola Treatment

19.07.2016 / 09:00
The issuer is solely responsible for the content of this announcement.


Press Release

RedHill Biopharma Announces Research Collaboration with NIH for Potential
Ebola Treatment

TEL-AVIV, Israel, July 18, 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 the
signing of a research collaboration agreement with the U.S. National
Institute of Allergy and Infectious Diseases (NIAID), part of the National
Institutes of Health (NIH), intended to evaluate RedHill’s proprietary
experimental therapy for the treatment of Ebola virus disease.

The new research collaboration follows encouraging results from preliminary
non-clinical studies conducted in conjunction with the NIAID using
RedHill’s proprietary experimental therapy. The objectives of the new
research collaboration between RedHill and NIAID are to evaluate survival
outcome and assess disease severity through comparison of viral loads and
cytokine levels in active treatment arms and placebo. If successful, this
study is intended to provide supportive data for discussions with the U.S.
Food and Drug Administration (FDA) for potential use of the Animal Rule
pathway for approval. According to FDA guidelines, approval under the
Animal Rule can be pursued only if human efficacy studies cannot be
conducted because the conduct of such trials is unethical or not

Ebola virus disease is a severe and often fatal illness which can cause
severe hemorrhagic fever in humans and has a mortality rate ranging from
25% to 90%[2]. There is currently no FDA approved treatment for Ebola virus

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.

About the National Institute of Allergy and Infectious Diseases (NIAID)
NIAID conducts and supports research-at NIH, throughout the United States,
and worldwide-to study the causes of infectious and immune-mediated
diseases, and to develop better means of preventing, diagnosing and
treating these illnesses. News releases, fact sheets and other NIAID-
related materials are available on the NIAID website.

About the National Institutes of Health (NIH):
NIH, the United States’ medical research agency, includes 27 Institutes and
Centers and is a component of the U.S. Department of Health and Human
Services. NIH is the primary federal agency conducting and supporting
basic, clinical, and translational medical research, and is investigating
the causes, treatments, and cures for both common and rare diseases. For
more information about NIH and its programs, visit www.nih.gov.

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:                                      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

[1] Product Development Under the Animal Rule – Guidance for Industry, U.S.
Department of Health and Human Services, Food and Drug Administration,
Center for Drug Evaluation and Research (CDER), Center for Biologics
Evaluation and Research (CBER), October 2015.
[2] World Health Organization (WHO), Fact sheet No° 103, January 2016.


19.07.2016 Dissemination of a Corporate News, transmitted by DGAP – a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Archive at www.dgap.de


483361 19.07.2016