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 Ocaliva® (obeticholic acid) has been granted the
2017 Premio Galeno Italia (Prix Galien) Chemical Synthesis Drug
Award.
The Premio Galeno Italia is one of the most recognized honors in
the Italian life sciences industry, and this award reflects the
innovation Ocaliva represents as a novel treatment for primary
biliary cholangitis (PBC). PBC is a rare autoimmune liver disease
that, if left untreated, can progress to hepatic fibrosis,
cirrhosis, liver failure, and death unless a patient receives a
liver transplant.
For almost 20 years ursodeoxycholic acid (UDCA) was the only
approved treatment for PBC; however, a substantial proportion of
patients do not adequately respond to UDCA or are intolerant to
UDCA. Ocaliva, which is a farnesoid X receptor (FXR) agonist, is
indicated to address these patients with high unmet need.
The Scientific Board that awarded the prize stated that Ocaliva
is “very innovative both from the point of view of patients and
therapeutically” and noted that the mechanism of action is both
different and complementary to UDCA, allowing Ocaliva to more
directly, and effectively, modulate the molecular and cellular
mechanisms which underlie the disease.
The Ocaliva story began in Italy. Professor Roberto Pellicciari
and a team of researchers at the University of Perugia pioneered
research in the field of bile acid chemistry in the 1990s, which
led to the discovery of obeticholic acid. Professor Pellicciari
helped found Intercept in 2002 to advance obeticholic acid and
discover other molecules under an ongoing collaboration that has
underpinned the innovation recognized today.
In May 2016, the U.S. Food and Drug Administration granted
accelerated approval to Ocaliva for the treatment of PBC in
combination with UDCA in adults with an inadequate response to UDCA
or as monotherapy in adults unable to tolerate UDCA. This was
followed in December 2016 by conditional marketing authorization in
the European Union and conditional approval in Canada in May 2017
for the same indication.
“We are honored that Ocaliva has been recognized with the 2017
Premio Galeno Italia Chemical Synthesis Drug Award,” said Lisa
Bright, Intercept's President, International. “This is particularly
meaningful for us because the discovery of Ocaliva happened in
Italy. We would like to take the opportunity to thank the
scientific researchers, clinical investigators, and of course the
members of the PBC community for their longstanding partnership and
support over the years that successfully brought Ocaliva from bench
to bedside.”
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 Premio Galeno ItaliaIn 2017 the Premio
Galeno celebrates 25 years in Italy. Springer is the official
partner for Premio Galeno Italia since 2012.
The Premio Galeno includes two awards: The Award for Clinical or
Experimental Research and The Award for Drug Innovation. The Award
for Drug Innovation is assigned to a company that has developed a
drug, approved by the European Medicines Agency (EMA) or the
Italian Drug Agency AIFA not prior to 2013 (except for the “Special
25th anniversary” award).
The 2017 edition of the Galien Award Italy for Drug Innovation
includes the following categories:1.Chemical synthesis drug
award2.Biological drug award3.Immunologic drug award4.Orphan drug
award5.Real-World Evidence (RWE) award – Special 25th
anniversary
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. Where approved, Ocaliva is indicated 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.
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 the European Union from the European Medicines Authority. In May
2017, Ocaliva was issued a marketing authorization with conditions
from Health Canada, pending the results of trials to verify its
clinical benefit.
EU IMPORTANT SAFETY INFORMATION
ContraindicationsHypersensitivity to the active
substance or to any of the excipients and complete biliary
obstruction.
Warnings and PrecautionsElevations in alanine
amino transferase (ALT) and aspartate aminotransferase (AST) have
been observed in patients taking obeticholic acid. Clinical signs
and symptoms of hepatic decompensation have also been observed.
These events have occurred as early as within the first month of
treatment. Liver-related adverse events have primarily been
observed at doses higher than the maximum recommended dose of 10 mg
once daily. Patients should be monitored during treatment with
Ocaliva for elevations in liver biochemical tests and for the
development of liver-related adverse events. Dosage adjustments are
needed for patients with moderate (Child-Pugh Class B) or severe
(Child-Pugh Class C) hepatic impairment.
Severe pruritus was reported in 23% of patients treated with
Ocaliva 10 mg arm, 19% of patients in the Ocaliva titration arm and
7% of patients in the placebo arms. The median time to onset of
severe pruritus was 11, 158 and 75 days for patients in the Ocaliva
10 mg, Ocaliva titration and placebo arms, respectively. Management
strategies include the addition of bile acid binding resins or
antihistamines, dose reduction, reduced dosing frequency and/or
temporary dose interruption.
Adverse ReactionsThe most commonly reported
adverse reactions were pruritus (63%) and fatigue (22%). Other
common adverse reactions observed in clinical trials (> 5%) were
abdominal pain and discomfort, rash, oropharyngeal pain, dizziness,
constipation, arthralgia, thyroid function abnormality and
eczema.
Drug InteractionBile acid binding resins such
as cholestyramine, colestipol or colesevelam adsorb and reduce bile
acid absorption and may reduce efficacy of obeticholic acid. When
concomitant bile acid binding resins are administered, obeticholic
acid should be taken at least 4-6 hours before or 4-6 hours after
taking abile acid binding resin, or at as great an interval as
possible.
For detailed safety information for Ocaliva (obeticholic acid) 5
mg and 10 mg tablets including posology and method of
administration, special warnings, drug interactions and adverse
drug reactions, please see the European Summary of Product
Characteristics.
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 Statements This 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 activities anticipated to be
undertaken by Intercept regarding Ocaliva® in PBC; the acceptance
of Ocaliva as a treatment for PBC by healthcare providers, patients
and payors; the anticipated prevalence of and other epidemiological
estimates and market data related to PBC, including those related
to disease progression; the continued development of OCA and
Intercept's other product candidates, 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
Intercept Pharmaceuticals (NASDAQ:ICPT)
Historical Stock Chart
From Mar 2024 to Apr 2024
Intercept Pharmaceuticals (NASDAQ:ICPT)
Historical Stock Chart
From Apr 2023 to Apr 2024