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 the transaction between Intercept and Advanz Pharma
announced on May 5, 2022, has now closed. As a result of this
transaction, Intercept’s international business has been divested
and its international commercial and medical infrastructure have
transitioned to Advanz Pharma.
Upfront consideration for the transaction is $405 million,
subject to working capital, closing costs, France reimbursement
liability and other adjustments. An additional $45 million from
Advanz is contingent upon receipt of extensions of orphan drug
exclusivity from the EMA and MHRA. Intercept will also receive
royalties on future ex-U.S. net sales of obeticholic acid for
nonalcoholic steatohepatitis (NASH).
Intercept anticipates presenting revised financial guidance
during its 2Q 2022 earnings.
About InterceptIntercept is a biopharmaceutical
company founded in 2002 and focused on the development and
commercialization of novel therapeutics to treat progressive
non-viral liver diseases including primary biliary cholangitis
(PBC) and nonalcoholic steatohepatitis (NASH). For more
information, please visit www.interceptpharma.com or connect with
the company on Twitter and LinkedIn.
About
Ocaliva® (obeticholic
acid)OCALIVA, a farnesoid X receptor (FXR) agonist, is
indicated for the treatment of adult patients with primary biliary
cholangitis (PBC).
- without cirrhosis or
- with compensated cirrhosis who do not have evidence of portal
hypertension, either in combination with ursodeoxycholic acid
(UDCA) with an inadequate response to UDCA or as monotherapy in
patients unable to tolerate UDCA.
This indication is approved under accelerated approval based on
a reduction in alkaline phosphatase (ALP). An improvement in
survival or disease-related symptoms has not been established.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in confirmatory
trials.
IMPORTANT SAFETY INFORMATIONWARNING:
HEPATIC DECOMPENSATION AND FAILURE IN PRIMARY BILIARY CHOLANGITIS
PATIENTS WITH CIRRHOSIS
- Hepatic decompensation and failure, sometimes fatal or
resulting in liver transplant, have been reported with OCALIVA
treatment in primary biliary cholangitis (PBC) patients with either
compensated or decompensated cirrhosis.
- OCALIVA is contraindicated in PBC patients with
decompensated cirrhosis, a prior decompensation event, or with
compensated cirrhosis who have evidence of portal
hypertension.
- Permanently discontinue OCALIVA in patients who develop
laboratory or clinical evidence of hepatic decompensation; have
compensated cirrhosis and develop evidence of portal hypertension,
or experience clinically significant hepatic adverse reactions
while on treatment.
ContraindicationsOCALIVA is contraindicated in
patients with:
- decompensated cirrhosis (e.g., Child-Pugh Class B or C) or
a prior decompensation event
- compensated cirrhosis who have evidence of portal hypertension
(e.g., ascites, gastroesophageal varices, persistent
thrombocytopenia)
- complete biliary obstruction
Warnings and PrecautionsHepatic
Decompensation and Failure in PBC Patients with
Cirrhosis
Hepatic decompensation and failure, sometimes fatal or resulting
in liver transplant, have been reported with OCALIVA treatment in
PBC patients with cirrhosis, either compensated or decompensated.
Among post-marketing cases reporting it, median time to hepatic
decompensation (e.g., new onset ascites) was 4 months for patients
with compensated cirrhosis; median time to a new decompensation
event (e.g., hepatic encephalopathy) was 2.5 months for patients
with decompensated cirrhosis.
Some of these cases occurred in patients with decompensated
cirrhosis when they were treated with higher than the recommended
dosage for that patient population; however, cases of hepatic
decompensation and failure have continued to be reported in
patients with decompensated cirrhosis even when they received the
recommended dosage.
Hepatotoxicity was observed in the OCALIVA clinical trials. A
dose-response relationship was observed for the occurrence of
hepatic 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 in two 3-month, placebo-controlled clinical trials in
patients with primarily early stage PBC.
Routinely monitor patients for progression of PBC, including
hepatic adverse reactions, with laboratory and clinical assessments
to determine whether drug discontinuation is needed. Closely
monitor patients with compensated cirrhosis, concomitant hepatic
disease (e.g., autoimmune hepatitis, alcoholic liver disease),
and/or with severe intercurrent illness for new evidence of portal
hypertension (e.g., ascites, gastroesophageal varices, persistent
thrombocytopenia), or increases above the upper limit of normal in
total bilirubin, direct bilirubin, or prothrombin time to determine
whether drug discontinuation is needed. Permanently discontinue
OCALIVA in patients who develop laboratory or clinical evidence of
hepatic decompensation (e.g., ascites, jaundice, variceal bleeding,
hepatic encephalopathy), have compensated cirrhosis and develop
evidence of portal hypertension (e.g., ascites, gastroesophageal
varices, persistent thrombocytopenia), experience clinically
significant hepatic adverse reactions, or develop complete biliary
obstruction. If severe intercurrent illness occurs, interrupt
treatment with OCALIVA and monitor the patient’s liver function.
After resolution of the intercurrent illness, consider the
potential risks and benefits of restarting OCALIVA treatment.
Severe PruritusSevere 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 in a 12-month double-blind randomized controlled
clinical trial of 216 patients. Severe pruritus was defined as
intense or widespread itching, interfering with activities of daily
living, or causing severe sleep disturbance, or intolerable
discomfort, and typically requiring medical interventions. Consider
clinical evaluation of patients with new onset or worsening severe
pruritus. Management strategies include the addition of bile acid
binding resins or antihistamines, OCALIVA dosage reduction, and/or
temporary interruption of OCALIVA dosing.
Reduction in HDL-CPatients with PBC generally
exhibit hyperlipidemia characterized by a significant elevation in
total cholesterol primarily due to increased levels of high-density
lipoprotein-cholesterol (HDL-C). Dose-dependent reductions from
baseline in mean HDL-C levels were observed at 2 weeks in
OCALIVA-treated patients, 20% and 9% in the 10 mg and titration
arms, respectively, compared to 2% in the placebo arm. Monitor
patients for changes in serum lipid levels during treatment. For
patients who do not respond to OCALIVA after 1 year at the highest
recommended dosage that can be tolerated (maximum of 10 mg once
daily), and who experience a reduction in HDL-C, weigh the
potential risks against the benefits of continuing treatment.
Adverse ReactionsThe most common adverse
reactions (≥5%) are: pruritus, fatigue, abdominal pain and
discomfort, rash, oropharyngeal pain, dizziness, constipation,
arthralgia, thyroid function abnormality, and eczema.
Drug Interactions
- Bile Acid Binding ResinsBile acid binding resins such as
cholestyramine, colestipol, or colesevelam adsorb and reduce bile
acid absorption and may reduce the absorption, systemic exposure,
and efficacy of OCALIVA. If taking a bile acid binding resin, take
OCALIVA at least 4 hours before or 4 hours after taking the bile
acid binding resin, or at as great an interval as possible.
- WarfarinThe International Normalized Ratio (INR) decreased
following coadministration of warfarin and OCALIVA. Monitor INR and
adjust the dose of warfarin, as needed, to maintain the target INR
range when co-administering OCALIVA and warfarin.
- CYP1A2 Substrates with Narrow Therapeutic IndexObeticholic acid
may increase the exposure to concomitant drugs that are CYP1A2
substrates. Therapeutic monitoring of CYP1A2 substrates with a
narrow therapeutic index (e.g., theophylline and tizanidine) is
recommended when co-administered with OCALIVA.
- Inhibitors of Bile Salt Efflux PumpAvoid concomitant use of
inhibitors of the bile salt efflux pump (BSEP) such as
cyclosporine. Concomitant medications that inhibit canalicular
membrane bile acid transporters such as the BSEP may exacerbate
accumulation of conjugated bile salts including taurine conjugate
of obeticholic acid in the liver and result in clinical symptoms.
If concomitant use is deemed necessary, monitor serum transaminases
and bilirubin.
Please click here for Full
Prescribing Information, including Boxed
WARNING.To report SUSPECTED ADVERSE REACTIONS,
contact Intercept Pharmaceuticals, Inc. at 1-844-782-ICPT
or FDA at 1-800-FDA-1088
or www.fda.gov/medwatch.
Cautionary Note Regarding Forward-Looking
Statements This document contains forward-looking
statements (FLS), including regarding the transaction discussed
above. FLS include:- The possibility of orphan drug exclusivity
extensions,- The possibility of a contingent earnout,- The
possibility of future royalties on ex-U.S. net sales of obeticholic
acid (OCA) for NASH, and- The timing of revised financial
guidance.
Important factors could cause actual results to differ
materially from the FLS, including:- Factors that result in
Intercept not obtaining exclusivity extensions or an earnout
(whether those factors are regulatory, clinical, medical, legal,
operational, or otherwise),- Factors that result in Intercept not
obtaining royalties (including that OCA is not approved or not
commercialized ex-U.S. for NASH, at all or on a timeframe that
results in significant value for Intercept, whether for reasons of
efficacy, safety concerns, or otherwise), and- Factors that result
in delays in presentation of revised financial guidance (for
whatever reason, whether managerial, financial, or otherwise).
Contact For more information about
Intercept, please contact:
Investor inquiries: investors@interceptpharma.com
Media inquiries: media@interceptpharma.com
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