- Performance-based arrangement predicated on sales exceeding
predetermined levels
- Co-promotional agreement is consistent with Concordia's
strategic focus on operational excellence
OAKVILLE, ON, Jan. 3, 2017 /CNW/ - Concordia International
Corp. (the "Company") (NASDAQ: CXRX) (TSX: CXR) - together with its
subsidiaries ("Concordia") - an international specialty
pharmaceutical company focused on generic and legacy pharmaceutical
products and orphan drugs, today announced it has entered into a
three-year, co-promotion agreement with RedHill Biopharma Ltd.
(RedHill) (NASDAQ: RDHL) (TASE:
RDHL) through which the companies expect to expand sales of
Donnatal®, Concordia's product used in the treatment of
irritable bowel syndrome.
Under the terms of the agreement, RedHill intends to increase the promotion of
Donnatal® among U.S. doctors who treat irritable bowel
syndrome, with marketing efforts anticipated to begin during the
current quarter. Over the three-year period, RedHill intends to promote the product in up
to 30 sales territories.
RedHill will incur the sales
and marketing costs associated with promotional activities, while
Concordia will provide materials and samples. Concordia will keep
all revenue up to a predetermined level of sales and only after
reaching that predetermined level will revenue be shared between
the Company and RedHill.
Concordia also plans to continue to sell Donnatal® in
U.S. sales territories outside the scope of the RedHill agreement.
"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."
Dror Ben-Asher, Chief Executive
Officer of RedHill, said: "We are
pleased to partner with Concordia for the U.S. promotion of
Donnatal®. 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."
About Donnatal®
Donnatal® is
used as adjunctive therapy for irritable bowel syndrome, a
condition characterized by abdominal pain, bloating, and diarrhea
or constipation, and acute enterocolitis. It may also be useful as
adjunctive therapy for duodenal ulcer. For more information,
including prescribing information for Donnatal®, please
visit www.donnatal.com.
About RedHill Biopharma Ltd.
RedHill Biopharma Ltd.
(NASDAQ/TASE: RDHL) is a specialty biopharmaceutical company
headquartered in Israel, primarily
focused on the development and U.S. commercialization of late
clinical-stage, proprietary, orally-administered, small molecule
drugs for the treatment of gastrointestinal and inflammatory
diseases and cancer. RedHill has a
co-promotion agreement with Concordia for Donnatal®, an
oral commercial adjunctive therapy in the treatment of IBS and
acute enterocolitis. RedHill's
pipeline of proprietary products under development 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.
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.
Notice regarding forward-looking statements and
information:
This press release includes forward-looking
statements within the meaning of the United States Private
Securities Litigation Reform Act of 1995 and forward-looking
information within the meaning of Canadian securities laws,
regarding Concordia and its business, which may include, but are
not limited to the expected expansion of sales of
Donnatal® through the RedHill co-promotion agreement, Concordia's
strategic focus on operational excellence (including with respect
to the cost-effective approach to the promotion of
Donnatal®), the intention to increase the promotion of
Donnatal® among U.S. doctors who treat irritable bowel
syndrome, the marketing efforts associated with the RedHill co-promotion agreement and the timing
thereof, the number of territories in which RedHill will promote Donnatal®,
RedHill's motivation to promote
Donnatal® and their prior experience in gastroenterology
sales, and marketing Donnatal® to more key prescribers
who Concordia believes can help raise the product's profile and
potentially allow Concordia to reach more patients in the U.S.
Often, but not always, forward-looking statements and
forward-looking information can be identified by the use of words
such as "plans", "is expected", "expects", "scheduled", "intends",
"contemplates", "anticipates", "believes", "proposes" or variations
(including negative and grammatical variations) of such words and
phrases, or state that certain actions, events or results "may",
"could", "would", "might" or "will" be taken, occur or be achieved.
Such statements are based on the current expectations of
Concordia's management, and are based on assumptions and subject to
risks and uncertainties. Although Concordia's management believes
that the assumptions underlying these statements are reasonable,
they may prove to be incorrect. The forward-looking events and
circumstances discussed in this press release may not occur by
certain specified dates or at all and could differ materially as a
result of known and unknown risk factors and uncertainties
affecting Concordia, including risks associated with the inability
to promote Donnatal® effectively (including, without
limitation, the inability to increase the promotion of
Donnatal® among U.S. doctors who treat irritable bowel
syndrome), the inability to grow sales of Donnatal®
(including, without limitation, through the RedHill co-promotion agreement or due to
increased competition), the inability of RedHill to market Donnatal®
effectively (including, without limitation, with respect to any
delays in agreeing to a commercialization plan with RedHill), risks associated with RedHill not increasing the number of
territories to promote the product (including, without limitation,
the inability to promote the product in the 30 territories
described herein), RedHill's prior
sales experience not benefiting Concordia or the promotion of
Donnatal®, the inability to market Donnatal®
to more prescribers, risks associated with co-promotion agreements
(including, without limitation, with respect to indemnity
obligations, termination rights, acts that may be committed by
co-promotion partners that may result in liability to Concordia, or
the breach of contractual obligations (including unauthorized use
of intellectual property or confidential information)), the
inability to raise Donnatal®'s profile and/or reach more
patients in the U.S., the inability of the RedHill co-promotion agreement to increase
Concordia's revenues, risks associated with the regulatory status
of Donnatal®, the inability to develop a new strategic
plan and/or implement the Company's key priorities, Concordia's
securities, risks associated with developing new product
indications, increased indebtedness and leverage, the inability to
generate cash flows, revenues and/or stable margins, the inability
to grow organically, the inability to repay debt and/or satisfy
future obligations (including, without limitation, earn out
obligations), risks associated with Concordia's outstanding debt,
risks associated with the geographic markets in which Concordia
operates and/or distributes its products, risks associated with
fluctuations in exchange rates (including, without limitation,
fluctuations in currencies), risks associated with the use of
Concordia's products to treat certain diseases, the pharmaceutical
industry and the regulation thereof, regulatory investigations, the
failure to comply with applicable laws, risks relating to
distribution arrangements, possible failure to realize the
anticipated benefits of acquisitions and/or product launches, risks
associated with the integration of assets and businesses into
Concordia's business, product launches, the inability to launch
products, the fact that historical and projected financial
information may not be representative of Concordia's future
results, the failure to obtain regulatory approvals, economic
factors, market conditions, acquisition opportunities, risks
associated with the acquisition and/or launch of pharmaceutical
products, risks regarding clinical trials and/or patient enrollment
into clinical trials, the equity and debt markets generally, risks
associated with growth and competition (including, without
limitation, with respect to Concordia's niche, hard-to-make
products), general economic and stock market conditions, risks
associated with the United
Kingdom's exit from the European Union (including, without
limitation, risks associated with regulatory changes in the
pharmaceutical industry, changes in cross-border tariff and cost
structures and the loss of access to the European Union global
trade markets), risks related to patent infringement actions, the
loss of intellectual property rights, risks and uncertainties
detailed from time to time in Concordia's filings with the
Securities and Exchange Commission and the Canadian Securities
Administrators and many other factors beyond the control of
Concordia. Although Concordia has attempted to identify
important factors that could cause actual actions, events or
results to differ materially from those described in
forward-looking statements and forward-looking information, there
may be other factors that cause actions, events or results to
differ from those anticipated, estimated or intended. No
forward-looking statement or forward-looking information can be
guaranteed. Except as required by applicable securities laws,
forward-looking statements and forward-looking information speak
only as of the date on which they are made and Concordia undertakes
no obligation to publicly update or revise any forward-looking
statement or forward-looking information, whether as a result of
new information, future events, or otherwise.
SOURCE Concordia International Corp.