Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical
company focused on the development and commercialization of novel
therapeutics to treat progressive non-viral liver diseases, today
announced that Health Canada has granted a conditional approval for
Ocaliva (obeticholic acid) for the treatment of primary biliary
cholangitis (PBC), when used in combination with ursodeoxycholic
acid (UDCA) in adults with an inadequate response to UDCA or as
monotherapy in adults unable to tolerate UDCA.
PBC is a rare, progressive, autoimmune cholestatic liver disease
that puts patients at risk for life-threatening complications,
affecting an estimated 11,000 Canadians. PBC impacts people in the
prime of their lives and is the leading cause of liver
transplantation among women in Canada.
Ocaliva is a farnesoid X receptor (FXR) agonist that will fill
an important unmet need for patients who have an inadequate
response to, or are unable to tolerate, the standard of care, UDCA,
and therefore remain at significantly increased risk of liver
failure, need for liver transplantation, or death.
“A substantial number of PBC patients are not achieving
treatment goals with UDCA alone and a few cannot tolerate this
standard of care. Until now we have only had experimental
adjunctive therapies to help these non-responders with progressive
disease,” said Andrew Mason, MBS, FRCPI, Director of Research for
the Division of Gastroenterology and Hepatology at the University
of Alberta. “The introduction of Ocaliva will help to address this
critical need and provide an opportunity for physicians to revisit
treatment goals with their patients.”
Ocaliva has been issued a marketing authorization with
conditions (also known as a Notice of Compliance with Conditions or
NOC/c) from Health Canada, pending the results of trials to verify
its clinical benefit. Products approved under Health Canada's NOC/c
policy have demonstrated promising benefit, are of high quality and
possess an acceptable safety profile based on a benefit/risk
assessment. Further, Health Canada approval follows an
accelerated priority review of the Ocaliva New Drug Submission,
recognizing the unmet need for new therapies in PBC.
"We are excited to be introducing the first new treatment option
for PBC in over 20 years for Canadian patients so closely following
regulatory approval in the U.S. and Europe,” said Mark Pruzanski,
M.D., President and CEO of Intercept. “Health Canada’s approval is
encouraging news for patients and represents another important step
in Intercept's mission to improve the lives of people with
progressive non-viral liver diseases."
Intercept is actively pursuing reimbursement of Ocaliva with
private insurance carriers and public drug plans across Canada.
Intercept is committed to ensuring patients with PBC can access
Ocaliva as quickly and easily as possible and has launched the
Navigate™ Patient Support Program to provide comprehensive and
personalized support for eligible patients prescribed Ocaliva for
PBC.
“We are very excited that Canadians living with PBC will now
have an important new treatment option,” said Gail Wright,
President of the Canadian PBC Society. “It is such a promising time
for PBC patients, and the community has been energized by new
advances in research, growing disease awareness among the public
and clinicians and now the introduction of a much-needed new
therapy to help patients better manage their disease.”
About Primary Biliary Cholangitis Primary
biliary cholangitis (PBC) is a rare, autoimmune cholestatic liver
disease that puts patients at risk for life-threatening
complications. PBC is primarily a disease of women, afflicting
approximately one in 1,000 women over the age of 40. If left
untreated, survival of PBC patients is significantly worse than the
general population.
About Ocaliva™ (obeticholic acid)Ocaliva
(obeticholic acid) is an agonist of the farnesoid X receptor (FXR),
a nuclear receptor expressed in the liver and intestine. FXR is a
key regulator of bile acid, inflammatory, fibrotic and metabolic
pathways.
Ocaliva is indicated in Canada for the treatment of primary
biliary cholangitis (PBC) in combination with ursodeoxycholic acid
(UDCA) in adults with an inadequate response to UDCA, or as
monotherapy in adults unable to tolerate UDCA. Ocaliva has been
issued a marketing authorization with conditions from Health
Canada, pending the results of trials to verify its clinical
benefit.
In May 2016, the U.S. Food and Drug Administration granted
accelerated approval to Ocaliva for the treatment of PBC. In
December 2016, Ocaliva received conditional marketing authorization
in Europe from the European Medicines Authority.
CANADIAN IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Patients who are hypersensitive to this drug or to any
ingredient in the formulation or component of the container.
Ocaliva is contraindicated in patients with complete biliary
obstruction.
WARNINGS AND PRECAUTIONS
Liver-Related Adverse Reactions
In two 3-month, placebo-controlled clinical trials, a
dose-response relationship was observed for the occurrence of
liver-related adverse reactions including jaundice, worsening
ascites and primary biliary cholangitis flare with dosages of
Ocaliva of 10 mg once daily to 50 mg once daily (up to 5-times the
highest recommended dosage), as early as one month after starting
treatment with Ocaliva.
Monitor patients during treatment with Ocaliva for elevations in
liver biochemical tests and for the development of liver-related
adverse reactions. Weigh the potential risks against the benefits
of continuing treatment with Ocaliva in patients who have
experienced clinically significant liver-related adverse reactions.
Discontinue Ocaliva in patients who develop complete biliary
obstruction.
Severe Pruritus
Pruritus was mostly mild to moderate in severity and generally
started within the first month following the initiation of
treatment with Ocaliva and decreased in severity over time with
continued dosing. Severe pruritus was reported in 23% of patients
in the Ocaliva 10 mg arm, 19% of patients in the Ocaliva titration
arm, and 7% of patients in the placebo arm, respectively.
Management strategies include the addition of bile acid resins or
antihistamines, Ocaliva dosage reduction, and/or temporary
interruption of Ocaliva dosing.
ADVERSE REACTIONS
The most common adverse drug reactions reported in double-blind
clinical trials (frequency≥5%) were pruritus, fatigue,
constipation, oropharyngeal pain and arthralgia.
For detailed safety information for Ocaliva (obeticholic acid) 5
mg and 10 mg tablets please see the Product Monograph.
About Intercept Pharma Canada Inc. Intercept
Pharma Canada Inc. is the Canadian subsidiary of Intercept
Pharmaceuticals, Inc., founded in 2015 and based in Mississauga,
Ontario. Intercept is a proud member of Ontario’s biopharmaceutical
community, and is committed to helping support the needs of
Canada’s liver health community.
About InterceptIntercept is a biopharmaceutical
company focused on the development and commercialization of novel
therapeutics to treat progressive non-viral liver diseases,
including primary biliary cholangitis (PBC), nonalcoholic
steatohepatitis (NASH), primary sclerosing cholangitis (PSC) and
biliary atresia. Founded in 2002 in New York, Intercept now has
operations in the United States, Europe and Canada. Intercept’s
International headquarters are located in London. For more
information about Intercept, please visit www.interceptpharma.com.
Safe Harbor StatementsThis press release
contains "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995, including, but
not limited to, statements regarding the clinical relevance and
utility of ALP, bilirubin and the surrogate endpoint used in the
Phase 3 POISE trial to predict clinical outcomes, the acceptance of
OcalivaTM (obeticholic acid) as a treatment for PBC by healthcare
providers, patients and payors, the commercial availability of OCA
for the treatment of PBC and timelines related thereto, the
anticipated prevalence of and other epidemiological estimates and
market data related to PBC, and our strategic directives under the
caption "About Intercept." These "forward-looking statements" are
based on management's current expectations of future events and are
subject to a number of important risks and uncertainties that could
cause actual results to differ materially and adversely from those
set forth in or implied by such forward-looking statements. These
risks and uncertainties include, but are not limited to:
Intercept's ability to successfully commercialize Ocaliva in PBC,
and Intercept's ability to maintain its regulatory approval in
jurisdictions in which Ocaliva is approved for use in PBC; the
initiation, cost, timing, progress and results of Intercept's
development activities, preclinical studies and clinical trials;
the timing of and Intercept's ability to obtain and maintain
regulatory approval of OCA in PBC in countries outside the ones in
which it is approved and in indications other than PBC and any
other product candidates it may develop such as INT-767; conditions
that may be imposed by regulatory authorities on Intercept's
marketing approvals for its products and product candidates such as
the need for clinical outcomes data (and not just results based on
achievement of a surrogate endpoint), and any related restrictions,
limitations, and/or warnings in the label of any approved products
and product candidates; Intercept's plans to research, develop and
commercialize its product candidates; Intercept's ability to obtain
and maintain intellectual property protection for its products and
product candidates; Intercept's ability to successfully
commercialize its products and product candidates; the size and
growth of the markets for Intercept's products and product
candidates and its ability to serve those markets; the rate and
degree of market acceptance of any of Intercept's products, which
may be affected by the reimbursement received from payors; the
success of competing drugs that are or become available; regulatory
developments in the United States and other countries; the
performance of third-party suppliers and manufacturers; the
election by Intercept's collaborators to pursue research,
development and commercialization activities; Intercept's ability
to attract collaborators with development, regulatory and
commercialization expertise; Intercept's need for and ability to
obtain additional financing; Intercept's estimates regarding
expenses, revenues and capital requirements and the accuracy
thereof; Intercept's use of cash and short-term investments;
Intercept's ability to attract and retain key scientific or
management personnel; and other factors discussed under the heading
"Risk Factors" contained in our annual report on Form 10-K for the
year ended December 31, 2016 filed on March 1, 2017 as well as any
updates to these risk factors filed from time to time in our other
filings with the Securities and Exchange Commission. All
information in this press release is as of the date of the release,
and Intercept undertakes no duty to update this information unless
required by law.
Contact
For more information about Intercept Pharmaceuticals, please contact:
Mark Vignola
+1-646-747-1000
investors@interceptpharma.com
Christopher Frates
+1-646-757-2371
media@interceptpharma.com
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