RedHill Biopharma Announces Exclusive U.S. License from Entera Health for Commercial GI Product EnteraGam®
(Thomson Reuters ONE) -
* RedHill expects to initiate U.S. promotion of its two commercially-available
gastrointestinal specialty products, Donnatal(®(1)) and EnteraGam(®(2)), in
mid-2017
* Under the terms of the agreement, RedHill will pay Entera Health royalties
on net sales generated from the sale of EnteraGam(®) by RedHill
TEL-AVIV, Israel, April 05, 2017 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd.
(NASDAQ:RDHL) (Tel-Aviv Stock Exchange: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 (GI) and inflammatory diseases and
cancer, today announced the signing of an exclusive license agreement with
Entera Health Inc. ("Entera Health"), a privately held U.S. company focused on
the research, manufacturing, and commercialization of value-added proteins and
protein co-products, granting RedHill the exclusive U.S. rights to
EnteraGam(®2).
EnteraGam(®) is a commercially-available medical food intended for the dietary
management of chronic diarrhea and loose stools which must be administered under
medical supervision. 2016 net sales of EnteraGam(®) in the U.S. were over $5
million. EnteraGam(®) is a serum-derived bovine immunoglobulin/protein isolate
(SBI) with a unique mechanism of action intended to restore gut balance.
EnteraGam(®) has been studied for various uses, such as diarrhea-predominant
irritable bowel syndrome (IBS-D), inflammatory bowel disease (IBD) and human
immunodeficiency virus (HIV)-associated enteropathy(3).
Guy Goldberg, RedHill's Chief Business Officer, said: "We look forward to
initiating the promotion of Donnatal(®4) and EnteraGam(®) in mid-2017. We are
currently in advanced stages of building RedHill's commercial operations in the
U.S. and are excited to complement our product portfolio with a second
commercial product geared towards gastroenterologists. We would like to thank
our new partners at Entera Health and look forward to a successful long-term
partnership."
Adi Frish, RedHill's Senior VP, Business Development and Licensing, said: "This
is another important step in implementing our strategic plan of becoming a
revenue-generating, gastrointestinal-focused, specialty pharmaceutical company
in the U.S. We continue to pursue additional commercial product opportunities in
the specialty GI area to further expand our commercial operations. In parallel,
we continue to advance the development of our three Phase III GI products,
which, if approved by the FDA, we intend to commercialize in the U.S."
Aage Lauridsen, Entera Health's CEO, said: "We are very pleased to partner with
RedHill to secure the continued marketing of EnteraGam(®) in the U.S. and are
confident that RedHill's sales team will continue to grow the value of this
unique product."
Under the terms of the agreement, RedHill licensed the exclusive U.S. rights to
EnteraGam(®) for all indications for human use. RedHill will pay Entera Health
tiered royalties on net sales generated from the sale of EnteraGam(®) by
RedHill, and is not required to make any upfront or milestone payments. Under
the terms of the agreement, Entera Health will also grant RedHill certain U.S.
rights to its FDA-approved dicyclomine hydrochloride(5) oral solution USP (10
mg/5 ml), an antispasmodic and anticholinergic (antimuscarinic) agent indicated
for the treatment of functional bowel/irritable bowel syndrome.
Numerous publications of clinical studies and retrospective chart reviews
support the use of SBI in the dietary management of chronic diarrhea and loose
stools4. The combined effect of SBI is intended to fulfill a distinctive
nutritional requirement associated with various gastrointestinal conditions,
where chronic diarrhea or loose stools are present and normal dietary proteins
alone are insufficient. SBI has been shown in clinical studies to reduce loose
stools and improve stool consistency as well as other symptoms, such as
abdominal pain, bloating and urgency, in patients with chronic diarrhea and
loose stools(4). Several studies in patients suffering from inflammatory bowel
diseases, such as ulcerative colitis and Crohn's disease, suggest that SBI
improves clinical symptomatic management of patients who are not fully managed
on traditional therapies(4). SBI has also been studied in patients with fecal
incontinence with chronic diarrhea, in patients with celiac and non-celiac
gluten sensitivity with chronic diarrhea and in additional gastrointestinal
indications(4).
No significant interactions of EnteraGam(®) with commonly prescribed medications
or therapies have been reported. According to Entera Health, it is estimated
that since EnteraGam(®) was introduced in 2013, nearly 3 million doses of
EnteraGam(®) have been administered to patients in the U.S., with an overall
adverse events rate of less than 0.2%, with no serious adverse events attributed
to EnteraGam(®) during post-marketing surveillance.
In January 2017, RedHill announced an exclusive co-promotion agreement with a
subsidiary(6) of Concordia International Corp., granting RedHill certain
promotional rights in the U.S. for Donnatal(®), a prescription oral drug used
with other drugs in the treatment of irritable bowel syndrome (irritable colon,
spastic colon, mucous colitis) and acute enterocolitis (inflammation of the
small bowel).
About EnteraGam(®):
EnteraGam(® )(a 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 components(7), 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
disorders(8 )(9).
Safety Information:
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 Donnatal(®):
Donnatal(®) (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine
Hydrobromide), a prescription drug, is classified as possibly effective as an
adjunctive therapy in the treatment of irritable bowel syndrome (irritable
colon, spastic colon, mucous colitis) and acute enterocolitis. Donnatal(®) slows
the natural movements of the gut by relaxing the muscles in the stomach and
intestines and acts on the brain to produce a calming effect. Donnatal(®) comes
in two formulations: immediate release Donnatal(®) Tablets and immediate release
Donnatal(®) Elixir, a fast-acting liquid.
Important Safety Information:
Donnatal(® )is contraindicated in patients who have glaucoma, obstructive
uropathy, obstructive disease of the gastrointestinal tract, paralytic ileus,
unstable cardiovascular status, severe ulcerative colitis, myasthenia gravis,
hiatal hernia with reflux esophagitis, or known hypersensitivity to any of the
ingredients. Patients who are pregnant or breast-feeding or who have autonomic
neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease,
congestive heart failure, cardiac arrhythmias, tachycardia or hypertension
should notify their doctor before taking Donnatal(®). Side effects may include:
dryness of the mouth, urinary retention, blurred vision, dilation of pupils,
rapid heartbeat, loss of sense of taste, headache, nervousness, drowsiness,
weakness, dizziness, insomnia, nausea, vomiting and allergic reactions which may
be severe.
Further information, including prescribing information, can be found
on www.donnatal.com.
Please see the following website for complete important safety information about
Donnatal(®): http://www.donnatal.com/professionals/important-safety-information/
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange: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, as well as an exclusive license
agreement with Entera Health for EnteraGam(®), a medical food intended for the
dietary management, under medical supervision, of chronic diarrhea and loose
stools. 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, a completed proof-of-concept Phase IIa study for multiple
sclerosis and QIDP status for nontuberculous mycobacteria (NTM) infections;
(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 protease
inhibitor, targeting pancreatic cancer 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.
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 of 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; and (xii) estimates of the Company's expenses, future revenues capital
requirements and the Company's needs for additional financing; (xiii)
competitive 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. We assume no obligation to update any written or oral
forward-looking statement unless required by law.
________________________
(1) Donnatal(®) (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate,
Scopolamine Hydrobromide) is a prescription drug, classified as possibly
effective as an adjunctive therapy in the treatment of irritable bowel syndrome
(irritable colon, spastic colon, mucous colitis) and acute enterocolitis. For
more information, please see the prescribing
information: http://www.donnatal.com/wp-content/uploads/2015/02/2015-02-18-Risk-
Benefit-information-DTC-REV.-SE.pdf.
(2) EnteraGam(®) (a 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.
(3) See full list of publications
at: http://enteragam.com/assets/lib/EnteraGam_Product_Information.pdf.
(4) Donnatal(®) (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate,
Scopolamine Hydrobromide) is a prescription drug, classified as possibly
effective as an adjunctive therapy in the treatment of irritable bowel syndrome
(irritable colon, spastic colon, mucous colitis) and acute enterocolitis. For
more information, please see the prescribing
information: http://www.donnatal.com/wp-content/uploads/2015/02/2015-02-18-Risk-
Benefit-information-DTC-REV.-SE.pdf.
(5) For more information, please see the prescribing
information: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/007409s04
1lbl.pdf.
(6) Concordia Pharmaceuticals Inc.
(7) 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.
(8) 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.
(9) 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.
Company contact:
Adi Frish
Senior VP Business Development &
Licensing
RedHill Biopharma
+972-54-6543-112
adi(at)redhillbio.com
IR contact (U.S.):
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
Mnanus(at)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
Datum: 05.04.2017 - 13:00 Uhr
Sprache: Deutsch
News-ID 534666
Anzahl Zeichen: 19223
contact information:
Town:
Tel-Aviv
Kategorie:
Business News
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"RedHill Biopharma Announces Exclusive U.S. License from Entera Health for Commercial GI Product EnteraGam®"
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