RedHill Biopharma and Express Scripts Subsidiary Inside Rx Add EnteraGam® to Savings Program for Uninsured or Underinsured P...
January 17 2018 - 07:00AM
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 announced that
EnteraGam® (serum-derived bovine immunoglobulin/protein
isolate, SBI)1 was added to the Inside RxSM prescription savings
program2. This program allows RedHill to provide a discount on
EnteraGam® directly to eligible patients who are uninsured or
underinsured.
- Inside Rx, a subsidiary of Express Scripts, is a leading
prescription savings program that provides more affordable access
to eligible, uninsured people who pay full list price for
prescription
medications.
- Savings on EnteraGam® under the Inside RxSM program could
benefit eligible uninsured patients and insured patients who choose
to pay out of pocket if their plan does not provide coverage of
EnteraGam®.
- EnteraGam® is a medical food intended for the dietary
management of chronic diarrhea and loose stools, which must be
administered under medical supervision.
Craig Miller, RedHill’s VP U.S. Business
Operations, Market Access, said: “RedHill is attentive to
patients’ needs and requests and is taking measures to make
EnteraGam® more affordable to them. We value our evolving
relationship with Inside Rx and look forward to continue working
with them to increase patient access for our products.”
About EnteraGam®:EnteraGam®
(serum-derived bovine immunoglobulin/protein isolate, SBI) is
a medical food product intended for the dietary management of
chronic diarrhea and loose stools. EnteraGam® must be
administered under medical supervision. EnteraGam® binds microbial
components3, such as toxic substances released by bacteria, that
upset the intestinal environment. This helps prevent them from
penetrating the lining of the intestine, which may contribute to
chronic diarrhea and loose stools in people who have specific
intestinal disorders4.
Safety Information about
EnteraGam®:EnteraGam® contains beef protein;
therefore, patients who have an allergy to beef or any other
component of EnteraGam® should not take this product.
EnteraGam® has not been studied in pregnant women, in women
during labor and delivery, or in nursing mothers. The choice
to administer EnteraGam® during pregnancy, labor and delivery,
or to nursing mothers is at the clinical discretion of the
prescribing physician.
EnteraGam® does not contain any
milk-derived ingredients such as lactose, casein or whey.
EnteraGam® is gluten-free, dye-free and soy-free.
Please see full Product
Information.
To report suspected adverse reactions, contact Entera Health, Inc.
at 1-855-4ENTERA (1-855-436-8372), or the FDA at 1-800-FDA-1088
(1-800-332-1088) or www.fda.gov/medwatch.
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 an ongoing confirmatory Phase III study and
successful results from a first Phase III study; (ii)
RHB-104 - an oral combination
therapy with an ongoing first Phase III study for Crohn's disease
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 an ongoing Phase IIa
study for cholangiocarcinoma; (iv) BEKINDA®
(RHB-102) - a once-daily oral
pill formulation of ondansetron with positive final results from a
Phase III study in acute gastroenteritis and gastritis and positive
top-line final results from a Phase II study in IBS-D; (v)
RHB-106 - an encapsulated bowel
preparation licensed to Salix Pharmaceuticals, Ltd. and (vi)
RHB-107 (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.
1 EnteraGam® (serum-derived bovine
immunoglobulin/protein isolate, SBI) is a commercially-available
medical food, intended for the dietary management of chronic
diarrhea and loose stools due to specific intestinal disorders,
which must be administered under medical supervision.2
https://insiderx.com/featured-medications3 Horgan A, Maas K,
Henderson A, Detzel C, Weaver E. Serum-derived bovine
immunoglobulin/protein isolate binds to pathogen-associated
molecular patterns. Poster presented at: Federation of American
Societies for Experimental Biology; April 26-30, 2014; San Diego,
CA.4 Petschow BW, Burnett B, Shaw AL, Weaver EM, Klein GL.
Serum-derived bovine immunoglobulin/protein isolate: postulated
mechanism of action for management of enteropathy. Clin Exp
Gastroenterol. 2014;7:181-190.Gasbarrini A, Lauritano EC, Garcovich
M, Sparano L, Gasbarrini G. New insights into the pathophysiology
of IBS: intestinal microflora, gas production and gut motility. Eur
Rev Med Pharmacol Sci. 2008;12 Suppl 1:111-117.
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.
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 |
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