RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE: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 and inflammatory diseases and cancer, today
announced the signing of an exclusive co-promotion agreement with a
subsidiary2 of Concordia International Corp. (NASDAQ:CXRX)
(TSX:CXR) (“Concordia”), an international specialty pharmaceutical
company focused on generic and legacy pharmaceutical products and
orphan drugs, granting RedHill certain U.S. promotion rights 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)3.
Under the terms of the agreement, RedHill will
be responsible for certain promotional activities related to
Donnatal®. Concordia will continue to be responsible for the
manufacturing and supply of Donnatal® in all territories. Donnatal®
accounted for 7.7% of Concordia’s consolidated revenues in the
first half of 20164. RedHill and Concordia will share the revenues
generated from the promotion of Donnatal® by RedHill based on an
agreed upon split between them. The initial term of the
co-promotion agreement with Concordia is for three years. RedHill
expects to initiate gradual promotion of Donnatal® in the coming
months.
Dror Ben-Asher, Chief Executive Officer
of RedHill, said: “We are pleased to
partner with Concordia for the U.S. promotion of Donnatal®, a
trusted brand among physicians for symptoms of IBS and acute
enterocolitis5. With a core U.S. commercial team in place, we plan
to initiate promotional activities in the U.S. in the coming months
with a specialty gastrointestinal sales force. RedHill’s strategic
transition into a revenue-generating, gastrointestinal-focused,
specialty pharmaceutical company with commercial presence in the
U.S., is planned to support potential future commercialization of
our Phase III-stage potential blockbusters
BEKINDA® for gastroenteritis and other GI
indications, RHB-105 for H. pylori infection and RHB-104 for
Crohn’s disease, if approved by FDA.”
“This agreement is a cost-effective approach to
promoting Donnatal® in a manner consistent with our long-term
strategic focus on operational excellence,” said Allan
Oberman, Chief Executive Officer of Concordia. “RedHill’s
commercial team is highly motivated and has previous experience in
gastroenterology sales. We look forward to partnering with them to
market Donnatal® to more key prescribers who we believe can help
raise the product’s profile and potentially allow us to reach more
patients in the U.S.”
About IBS: Irritable bowel
syndrome (IBS) is a chronic multifactorial disorder characterized
by recurrent abdominal pain or discomfort associated with altered
bowel function. Certain factors that may alter gastrointestinal
function can contribute to IBS symptoms, including stress, prior
gastroenteritis and changes in the gut microbiome. However, the
etiology of IBS is not understood and the underlying cause of IBS
remains unknown. IBS negatively impacts patients’ quality of life
and can affect patients physically, emotionally, socially and
economically. IBS is one of the most common gastrointestinal
disorders. It is estimated that at least 30 million Americans
suffer from IBS6. The U.S. potential market for IBS treatments is
estimated to exceed $2.3 billion by 20207. Studies estimate that
IBS affects 10 to 15 percent of U.S. adults, with about twice as
many women as men and most often occurs in people younger than age
458.
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.
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 important
safety information about Donnatal®:
http://www.donnatal.com/professionals/important-safety-information/
About Concordia: Concordia is a
diverse, international specialty pharmaceutical company focused on
generic and legacy pharmaceutical products and orphan drugs. The
Company has an international footprint with sales in more than 100
countries, and has a diversified portfolio of more than 200
established, off-patent molecules that make up more than 1,300
SKUs. Concordia also markets orphan drugs through its Orphan Drugs
Division, consisting of Photofrin® for the treatment of certain
rare forms of cancer. Concordia operates out of facilities
in Oakville, Ontario and, through its subsidiaries,
operates out of facilities in Bridgetown,
Barbados; London, England and Mumbai, India.
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE: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. 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 and a completed proof-of-concept Phase IIa study
for multiple sclerosis; (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 uPA inhibitor,
targeting gastrointestinal 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.
1 Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate,
Scopolamine Hydrobromide.
2 Concordia Pharmaceuticals Inc.
3 This drug has been evaluated as possibly effective for
these indications. 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.
4 Concordia International Investor Presentation October
2016.
5 An inflammation of the small bowel.
6 Lovell RM, Ford AC, Global prevalence of and risk factors
for irritable bowel syndrome: a meta-analysis, Clin Gastroenterol
Hepatol (2012), 10(7)712-721; Saito YA et al, The epidemiology of
irritable bowel syndrome in North America: a systemic review, Am J
Gastroenterol (2002), 97(8): 1910-5.
7 EvaluatePharma - Irritable bowel syndrome Indication
Profile.
8 Grundmann O, Yoon SL. Irritable bowel syndrome:
epidemiology, diagnosis, and treatment: an update for health-care
practitioners. Journal of Gastroenterology and
Hepatology. 2010;25:691–699.
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:
Adi Frish
Senior VP Business Development & Licensing
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
IR contact (U.S.):
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
Mnanus@troutgroup.com