Alfasigma S.p.A. (“Alfasigma”) and Intercept Pharmaceuticals, Inc.
(“Intercept”) announced today the completion of the acquisition of
Intercept by Alfasigma through its wholly owned subsidiary
Interstellar Acquisition Inc.
Following the completion of Alfasigma’s
successful tender offer to purchase all outstanding shares of
common stock of Intercept for USD 19.00 per share, net to the
seller thereof in cash, without interest, less any applicable
withholding of taxes, Alfasigma acquired all remaining shares of
common stock of Intercept through a merger pursuant to Section
251(h) of the General Corporation Law of the State of Delaware. As
a result of the transaction, Intercept has become a wholly owned
subsidiary of Alfasigma, and the common stock of Intercept has
ceased to be traded on the NASDAQ Stock Market.
At the effective time of the merger, and subject
to any perfected appraisal rights, all of the remaining shares of
common stock of Intercept not purchased in the tender offer were
converted into the right to receive the same USD 19.00 per share,
net to the seller thereof in cash, without interest, less any
applicable withholding of taxes.
With this transaction, Alfasigma adds Ocaliva to
its portfolio, the only second-line treatment approved by the Food
and Drug Administration (FDA) for primary biliary cholangitis
(PBC), a progressive autoimmune disease affecting the liver. The
deal will strengthen Alfasigma's pipeline, with the addition of a
novel fixed-dose combination possibly establishing a new treatment
paradigm for PBC.
Stefano Golinelli, Chairman of
Alfasigma, commented: “At Alfasigma, the passion we have
for Pharmaceuticals is in our DNA - and a driver for our ambitious
international growth plans. Thus, we are delighted to announce the
successful outcome of our tender offer for Intercept
Pharmaceuticals, Inc. This transaction not only allows us to expand
our portfolio with Ocaliva, a leading treatment against PBC, it is
also central to strengthening our presence in the highly attractive
US market. This deal represents an important opportunity for both
companies, and certifies Alfasigma’s commitment to our mission of
improving people’s health and quality of life”.
Francesco Balestrieri, CEO of Alfasigma,
added: “Today, we complete a transformational acquisition
which strongly aligns with our strategy of building a solid
presence in gastroenterology and hepatology, Alfasigma’s core
business areas. Intercept’s leading product Ocaliva is the first
and only FDA approved second line treatment for adult patients with
PBC. Furthermore, Alfasigma will benefit from a strengthened
innovation and R&D pipeline, including the addition of a novel
fixed-dose combination of obeticholic acid and bezafibrate with
potential to establish a new paradigm in the treatment of patients
with PBC. This deal represents a significant progress in
Alfasigma's international growth plan, and we look forward to
working with our colleagues at Intercept to provide innovative and
effective treatment options for patients affected by severe liver
diseases, and to growing our business in
the United States”.
Forward-looking statements
This press release may contain forward-looking
statements by Alfasigma that involve risks and uncertainties and
reflect Alfasigma’s judgment as of the date of this press release.
These forward-looking statements generally are identified by words
such as “believe,” “project,” “expect,” “anticipate,” “estimate,”
“intend,” “strategy,” “future,” “opportunity,” “plan,” “may,”
“should,” “will,” “would,” and similar expressions. Forward-looking
statements are predictions, projections and other statements about
future events that are based on current expectations and
assumptions and, as a result, are subject to risks and
uncertainties. Actual events or results may differ from Alfasigma’s
expectations due to risks and uncertainties inherent in Alfasigma’s
business, including, without limitation: litigation relating to the
transaction; risks that the transaction disrupts the current plans
and operations of Alfasigma or Intercept; the ability of Intercept
to retain key personnel; competitive responses to the transaction;
unexpected costs, charges or expenses resulting from the
transaction; potential adverse reactions or changes to business
relationships resulting from the announcement of the transaction;
Alfasigma’s ability to achieve the growth prospects and synergies
expected from the transaction, as well as delays, challenges and
expenses associated with integrating Intercept with its existing
businesses; legislative, regulatory and economic developments; and
other risks described in Alfasigma’s prior press releases. These
forward-looking statements are made only as of the date hereof and
Alfasigma disclaims any intent or obligation to update these
forward looking statements after the date hereof, except as
required by law.
About Alfasigma
Alfasigma is one of Italy's
leading pharmaceutical companies with a strong international
position. The Group has a worldwide presence in over 100 countries
where about 3000 people work in research, development, production
and distribution. In Italy, Alfasigma is a leader in the
prescription products market where, in addition to its strong focus
on gastro-intestinal products, it is present in several primary
care therapeutic areas. It is popular with the consumer public for
a number of nutraceuticals & food supplements that respond to
different needs, and that are well known and deeply rooted in the
Italian families experience. Its historical headquarters is in
Bologna, to which is added Milan, while the production sites are:
in Italy, in Pomezia (RM), Alanno (PE), Sermoneta (LT) and Trezzano
Rosa (MI) and abroad in Tortosa in Spain and in Shreveport
(Louisiana) in the United States. The R&D laboratories are in
Pomezia and in the Parco Scientifico Tecnologico Kilometro Rosso in
Bergamo. Alfasigma's mission is to improve people's health and
quality of life by offering caregivers and healthcare personnel
therapeutic solutions according to the highest standards of quality
and safety.
About Intercept
Intercept is a
biopharmaceutical company focused on the development and
commercialization of novel therapeutics to treat rare and serious
liver diseases, including primary biliary cholangitis (PBC) and
severe alcohol-associated hepatitis (sAH). 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 INFORMATION
WARNING: 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.
Contraindications
OCALIVA 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 Precautions
Hepatic Decompensation and Failure in PBC Patients with
CirrhosisHepatic 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.
Contact Information:
Alfasigma S.p.A. Corporate CommunicationSimona
Gelpi simona.gelpi@alfasigma.comGea Gardini
gea.gardini@alfasigma.comwww.alfasigma.it
iCorporateLuca Bolzoni
luca.bolzoni@icorporate.it +39.347.6498627Alberto Colombini
alberto.colombini@icorporate.it + 39.335.1222631
Tancredi Intelligent CommunicationEmma
Valgimigli emma@tancredigroup.comEmma Hodges
hemma@tancredigroup.comalfasigma@tancredigroup.com+44 203 434
2330
Intercept Pharmaceuticals (NASDAQ:ICPT)
Graphique Historique de l'Action
De Avr 2024 à Mai 2024
Intercept Pharmaceuticals (NASDAQ:ICPT)
Graphique Historique de l'Action
De Mai 2023 à Mai 2024