A new differentiated treatment option for GI
disorders
Transaction broadens Cipher's Canadian
portfolio providing entry into rapidly growing market where
innovative treatments are needed
MISSISSAUGA, ON, Feb. 28, 2018 /PRNewswire/ - Cipher
Pharmaceuticals Inc. (TSX:CPH) ("Cipher" or "the Company") today
announced it has acquired the exclusive Canadian rights to right to
develop, market, distribute and sell TRULANCE®
(plecanatide) from Synergy Pharmaceuticals Inc. (NASDAQ:SGYP)
("Synergy"). TRULANCE is a once-daily tablet approved by the U.S.
Food and Drug Administration ("FDA") for the treatment of adults
with chronic idiopathic constipation ("CIC") and irritable bowel
syndrome with constipation ("IBS-C").
"We are excited at the prospect of bringing an innovative new
product to market that would be a safe and effective treatment
option for the many Canadians who suffer from these chronic GI
disorders," said Robert Tessarolo, President and CEO of
Cipher. "TRULANCE has established a strong and remarkably
consistent efficacy and safety profile in clinical trials with more
than 4,700 CIC and IBS-C patients."
Mr. Tessarolo added: "Our growth strategy is aimed at assembling
a diversified portfolio of prescription medicines across a range of
therapeutic areas. This agreement brings a new and differentiated
GI product into our Canadian portfolio and demonstrates the
continued execution of our strategy. We are targeting a New Drug
Submission to Health Canada later this year and potential approval
and product launch in 2019."
It is estimated that one in four Canadians has symptoms of
constipation and an estimated 38% of Canadians report constipation
within the previous 12 months1. According to IMS, the
total Canadian laxative and antispasmodic market (prescription and
OTC) was valued at over CDN$200
million for the 12 months ending September 2017.
"As an emerging leader in the Canadian healthcare industry,
Cipher is an ideal partner to commercialize TRULANCE in
Canada. Their impressive
management team and track record of successfully commercializing
medicines in Canada were critical
decision-making factors in this collaboration," said Troy Hamilton, Chief Executive Officer of
Synergy Pharmaceuticals Inc. "This licensing agreement demonstrates
our unwavering commitment to bring TRULANCE to as many patients and
their health care providers as possible."
Under the terms of the licensing agreement, Synergy will receive
an upfront payment of US$5.0 million and is eligible for
an additional milestone payment, as well as royalties from product
sales in Canada. The agreement provides that Synergy will be
responsible for manufacturing and supplying finished product to
Cipher.
About Irritable Bowel Syndrome with Constipation
(IBS-C)
Irritable bowel syndrome (IBS) is a chronic
gastrointestinal disorder characterized by recurrent abdominal pain
and associated with two or more of the following: related to
defecation, associated with a change in the frequency of stool, or
associated with a change in the form (appearance) of the stool. IBS
can be subtyped by the predominant stool form: constipation
(IBS-C), diarrhea (IBS-D) or mixed (IBS-M). Those within the IBS-C
subtype experience hard or lumpy stools more than 25 percent of the
time they defecate, and loose or watery stools less than 25 percent
of the time.
About Chronic Idiopathic Constipation (CIC)
CIC
affects approximately 14 percent of the global population,
disproportionately affecting women and older adults. People with
CIC have persistent symptoms of difficult-to-pass and infrequent
bowel movements. In addition to physical symptoms including
abdominal bloating and discomfort, CIC can adversely affect an
individual's quality of life, including increasing stress levels
and anxiety.
About TRULANCE CIC and IBS-C Phase 3 Clinical
Programs
The efficacy and safety of TRULANCE for the
treatment of CIC and IBS-C was established in four 12-week,
double-blind, placebo-controlled, randomized, multicenter clinical
studies involving over 4,700 patients. TRULANCE demonstrated
improvement in FDA endpoints assessing abdominal pain,
constipation, stool consistency and straining with bowel movements
associated with IBS-C, as well as in the constipation, stool
consistency and straining with bowel movements associated with CIC.
These patient-reported symptoms returned within one week following
discontinuation of TRULANCE. The most common adverse event in both
CIC and IBS-C studies was diarrhea (≤5.0% vs. 1.0% placebo).
About TRULANCE®
TRULANCE®
(plecanatide) is a once-daily tablet approved in the U.S. for
adults with CIC or IBS-C. With the exception of a single amino acid
substitution for greater binding affinity, TRULANCE is structurally
identical to uroguanylin, a naturally occurring and endogenous
human GI peptide. Uroguanylin activates GC-C receptors in a
pH-sensitive manner primarily in the small intestine, stimulating
fluid secretion and maintaining stool consistency necessary for
regular bowel function.
About Synergy Pharmaceuticals Inc.
Synergy is a
biopharmaceutical company focused on the development and
commercialization of novel gastrointestinal (GI) therapies. The
company has pioneered discovery, research and development efforts
around analogs of uroguanylin, a naturally occurring human GI
peptide, for the treatment of GI diseases and disorders. Synergy's
proprietary GI platform includes one commercial product
TRULANCE® (plecanatide) and a second product candidate –
dolcanatide. For more information, please
visit www.synergypharma.com.
About Cipher Pharmaceuticals Inc.
Cipher (TSX:CPH) is
a specialty pharmaceutical company with a robust and diversified
portfolio of commercial and early to late-stage products. Cipher
acquires products that fulfill unmet medical needs, manages the
required clinical development and regulatory approval process, and
markets those products either directly in Canada or indirectly through partners in
Canada, the U.S., and South America. Cipher is focused on a
three-pronged growth strategy – including acquisitions,
in-licensing, and selective investments in drug development – to
assemble a broad portfolio of prescription products that serve
unmet medical needs. For more information, visit
www.cipherpharma.com.
Forward-Looking Statements
This document includes
forward-looking statements within the meaning of certain securities
laws, including the "safe harbour" provisions of the Securities Act
(Ontario) and other provincial
securities law in Canada and U.S.
securities laws. These forward-looking statements include, among
others, statements with respect to our objectives, goals and
strategies to achieve those objectives and goals, as well as
statements with respect to our beliefs, plans, expectations,
anticipations, estimates and intentions. The words "may", "will",
"could", "should", "would", "suspect", "outlook", "believe",
"plan", "anticipate", "estimate", "expect", "intend", "forecast",
"objective", "hope" and "continue" (or the negative thereof), and
words and expressions of similar import, are intended to identify
forward-looking statements.
By their very nature, forward-looking statements involve
inherent risks and uncertainties, both general and specific, which
give rise to the possibility that predictions, forecasts,
projections and other forward-looking statements will not be
achieved. Certain material factors or assumptions are applied in
making forward-looking statements and actual results may differ
materially from those expressed or implied in such statements. We
caution readers not to place undue reliance on these statements as
a number of important factors, many of which are beyond our
control, could cause our actual results to differ materially from
the beliefs, plans, objectives, expectations, anticipations,
estimates and intentions expressed in such forward-looking
statements. These factors include, but are not limited to, our
ability to enter into in-licensing, development, manufacturing and
marketing and distribution agreements with other pharmaceutical
companies and keep such agreements in effect; our dependency on a
limited number of products; integration difficulties and other
risks if we acquire or in-license technologies or product
candidates; reliance on third parties for the marketing of certain
products; the product approval process is highly unpredictable; the
timing of completion of clinical trials; reliance on third parties
to manufacture our products and events outside of our control that
could adversely impact the ability of our manufacturing partners to
supply products to meet our demands; we may be subject to future
product liability claims; unexpected product safety or efficacy
concerns may arise; we generate license revenue from a limited
number of distribution and supply agreements; the pharmaceutical
industry is highly competitive; requirements for additional capital
to fund future operations; dependence on key managerial personnel
and external collaborators; no assurance that we will receive
regulatory approvals in the U.S., Canada or any other jurisdictions; current
uncertainty surrounding health care regulation in the United States; certain of our products are
subject to regulation as controlled substances; limitations on
reimbursement in the healthcare industry; limited reimbursement for
products by government authorities and third-party payor policies;
various laws pertaining to health care fraud and abuse; reliance on
the success of strategic investments and partnerships; the
publication of negative results of clinical trials; unpredictable
development goals and projected time frames; rising insurance
costs; ability to enforce covenants not to compete; risks
associated with the industry in which it operates; we may be
unsuccessful in evaluating material risks involved in completed and
future acquisitions; we may be unable to identify, acquire or
integrate acquisition targets successfully; inability to meet
covenants under our long term debt arrangement; compliance with
privacy and security regulation; our policies regarding returns,
allowances and chargebacks may reduce revenues; certain current and
future regulations could restrict our activities; additional
regulatory burden and controls over financial reporting; reliance
on third parties to perform certain services; general commercial
litigation, class actions, other litigation claims and regulatory
actions; the effects of our delisting from the NASDAQ Global Market
(the "NASDAQ") and deregistration of our Common Shares under the
U.S. Securities Exchange Act of 1934, as amended (the "U.S.
Exchange Act"); the difficulty for shareholders to realize in
the United States upon judgments
of U.S. courts predicated upon civil liability of the Company and
its directors and officers who are not residents of the United States; certain adverse tax rules
applicable to U.S. holders of our Common Shares if we are a passive
foreign investment company for U.S. federal income tax purposes;
the potential violation of intellectual property rights of third
parties; our efforts to obtain, protect or enforce our patents and
other intellectual property rights related to our products; changes
in U.S., Canadian or foreign patent laws; litigation in the
pharmaceutical industry concerning the manufacture and supply of
novel and generic versions of existing drugs; inability to protect
our trademarks from infringement; shareholders may be further
diluted if we issue securities to raise capital; volatility of our
share price; the actions of a significant shareholder; we do not
currently intend to pay dividends; our operating results may
fluctuate significantly; and our debt obligations will have
priority over the Common Shares in the event of a liquidation,
dissolution or winding up.
We caution that the foregoing list of important factors that
may affect future results is not exhaustive. When reviewing our
forward-looking statements, investors and others should carefully
consider the foregoing factors and other uncertainties and
potential events. Additional information about factors that may
cause actual results to differ materially from expectations, and
about material factors or assumptions applied in making
forward-looking statements, may be found in the "Risk Factors"
section of this AIF and in our Management's Discussion and Analysis
of Operating Results and Financial Position for the year ended
December 31, 2017, and elsewhere in
our filings with Canadian securities regulators. Except as required
by Canadian securities law, we do not undertake to update any
forward-looking statements, whether written or oral, that may be
made from time to time by us or on our behalf; such statements
speak only as of the date made. The forward-looking statements
included herein are expressly qualified in their entirety by this
cautionary language.
(1) "Understanding the Prevalence and
Impact of Constipation in Canada":
A Special Report from the Canadian Digestive Health
Foundation.
SOURCE Cipher Pharmaceuticals Inc.