Alfasigma S.p.A (“Alfasigma”), one of Italy's leading
pharmaceutical companies, and Intercept Pharmaceuticals, Inc.
(Nasdaq: ICPT, “Intercept”), a leading biopharmaceutical company in
rare and serious liver diseases, today announced that they have
entered into a definitive merger agreement under which Alfasigma
has agreed to acquire Intercept for $19.00 per share in cash. The
anticipated transaction will materially expand Alfasigma’s
gastrointestinal and hepatology portfolio and its presence in the
U.S. market.
Intercept’s lead medicine is Ocaliva® (obeticholic acid), a
farnesoid X receptor agonist approved in the United States and
several other jurisdictions 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® is the only
approved second-line therapy for PBC and has experienced
double-digit year-over-year growth supported by an experienced
specialty sales force and strong prescriber base. Intercept also
benefits from a broader clinical development pipeline anchored by a
novel fixed-dose combination of obeticholic acid and bezafibrate in
phase 2 trials for PBC.
Mr. Stefano Golinelli, Chairman of Alfasigma Board,
declared: “Today’s proposed acquisition is aligned with
our strategy to build presence in the U.S. market, with a focus in
our core gastroenterological area while adding another important
asset to our innovation pipeline. This acquisition will contribute
to the ambitious growth strategy designed for our company.”
Mr. Francesco Balestrieri, Chief Executive Officer of
Alfasigma, said: “The acquisition of Intercept marks
another important milestone in Alfasigma’s growth path,
particularly with regard to the U.S. market in which we have
significant development objectives. Intercept represents a
compelling fit with Alfasigma’s core business areas of
gastroenterology and hepatology, and we believe that the
transaction represents a transformational opportunity for both
companies. We are excited to welcome Intercept employees and look
forward to working together as we invest in the company to realize
the full potential, to the benefit of patients.”
Mr. Jerry Durso, President and Chief Executive Officer
of Intercept, commented: “We are pleased to announce this
transaction with Alfasigma, which delivers significant value to
shareholders. Importantly, it recognizes the value of our
portfolio, R&D and commercial capabilities and our talented
people across the organization. The team at Intercept is proud of
the breakthrough, innovative work that we have done as a pioneer,
delivering life-saving medicine to patients with rare and serious
liver diseases such as PBC.”
Transaction Terms
Under the terms of the merger agreement, Alfasigma has agreed to
commence a cash tender offer to acquire all issued and outstanding
shares of Intercept common stock for US$19.00 per share in cash.
The purchase price represents a premium of 82% to Intercept’s
closing stock price on September 25, 2023.
The transaction will be fully financed by Alfasigma’s existing
cash on hand and existing corporate credit facilities. The members
of the Board of Directors of Intercept participating in the
decision have unanimously approved the transaction.
The closing of the tender offer will be subject to customary
conditions, including the tender of shares which represent at least
a majority of the total number of Intercept’s outstanding shares of
common stock and the expiration of the waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act. Upon successful
completion of the tender offer, Alfasigma would acquire all shares
not acquired in the tender offer through a second-step merger for
the same consideration that the tendering stockholders will receive
in the tender offer.
It is anticipated the transaction will close by the end of 2023.
Upon completion of the transaction, Intercept’s common stock will
no longer be publicly listed.
Advisors
Barclays and Centerview Partners are serving as financial
advisors to Intercept. Skadden, Arps, Slate, Meagher & Flom LLP
are serving as legal counsel to Intercept. PJT Partners is acting
as exclusive financial advisor to Alfasigma and Sullivan &
Cromwell LLP and Chiomenti Studio Legale as legal counsel to
Alfasigma.
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
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 Pruritus 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 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-C Patients 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 Reactions The 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 Resins Bile
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.
- Warfarin The 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 Index Obeticholic 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
Pump Avoid 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.
Additional Information and Where to Find it
The tender offer described in this communication has not yet
commenced. This communication is for informational purposes only
and is neither an offer to purchase nor a solicitation of an offer
to sell shares of Intercept Pharmaceuticals, Inc. (the “Company”),
nor is it a substitute for any tender offer materials that the
Company or Alfasigma S.p.A. (together with its subsidiaries,
“Alfasigma”) will file with the SEC. A solicitation and an offer to
buy shares of the Company will be made only pursuant to an offer to
purchase and related materials that Alfasigma intends to file with
the SEC. At the time the tender offer is commenced, Alfasigma will
file a Tender Offer Statement on Schedule TO with the SEC, and the
Company will file a Solicitation/Recommendation Statement on
Schedule 14D-9 with the SEC with respect to the tender offer. THE
COMPANY’S STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE
TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED
LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND
THE SOLICITATION/RECOMMENDATION STATEMENT BECAUSE THEY WILL CONTAIN
IMPORTANT INFORMATION WHICH SHOULD BE READ CAREFULLY BEFORE ANY
DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. The Offer to
Purchase, the related Letter of Transmittal and certain other
tender offer documents, as well as the Solicitation/Recommendation
Statement, will be sent to all stockholders of the Company at no
expense to them. The Tender Offer Statement and the
Solicitation/Recommendation Statement will be made available for
free at the SEC’s website at www.sec.gov. Additional copies may be
obtained for free by contacting Alfasigma or the Company. Free
copies of these materials and certain other offering documents will
be made available by the Company by mail to Intercept
Pharmaceuticals, Inc., 305 Madison Avenue, Morristown, NJ 07960,
Attention: Corporate Secretary, by email at
investors@interceptpharma.com, or by directing requests for such
materials to the information agent for the offer, which will be
named in the tender offer materials. Copies of the documents filed
with the SEC by the Company will be available free of charge under
the “Investors & Media” section of the Company’s internet
website at https://ir.interceptpharma.com/investor-relations.
In addition to the Offer to Purchase, the related Letter of
Transmittal and certain other tender offer documents, as well as
the Solicitation/Recommendation Statement, the Company files
periodic reports and other information with the SEC. The Company’s
filings with the SEC are also available for free to the public from
commercial document-retrieval services and at the website
maintained by the SEC at www.sec.gov.
Forward Looking Statements
This communication contains forward-looking statements related
to the Company, Alfasigma and the proposed acquisition of the
Company by Alfasigma (the “Transaction”) that involve substantial
risks and uncertainties. Forward-looking statements include any
statements containing the words “anticipate,” “believe,”
“estimate,” “expect,” “intend,” “goal,” “may,” “might,” “plan,”
“predict,” “project,” “seek,” “target,” “potential,” “will,”
“would,” “could,” “should,” “continue” and similar expressions. In
this communication, the Company’s forward-looking statements
include statements about the parties’ ability to satisfy the
conditions to the consummation of the tender offer and the other
conditions to the consummation of the Transaction; statements about
the expected timetable for completing the Transaction; the
Company’s plans, objectives, expectations and intentions; the
financial condition, results of operations and business of the
Company and Alfasigma; the ability to successfully commercialize
the Company’s product and product candidates and generate future
revenues with respect to the Company’s product candidates; and the
anticipated timing of the closing of the Transaction.
Forward-looking statements are subject to certain risks,
uncertainties, or other factors that are difficult to predict and
could cause actual events or results to differ materially from
those indicated in any such statements due to a number of risks and
uncertainties. Those risks and uncertainties that could cause the
actual results to differ from expectations contemplated by
forward-looking statements include, among other things:
uncertainties as to the timing of the tender offer and merger;
uncertainties as to how many of the Company’s stockholders will
tender their stock in the offer; the possibility that competing
offers will be made; the possibility that various closing
conditions for the Transaction may not be satisfied or waived,
including that a governmental entity may prohibit, delay or refuse
to grant approval for the consummation of the Transaction; the
effects of the Transaction on relationships with employees, other
business partners or governmental entities; the difficulty of
predicting the timing or outcome of FDA approvals or actions, if
any; the impact of competitive products and pricing; that Alfasigma
may not realize the potential benefits of the Transaction; other
business effects, including the effects of industry, economic or
political conditions outside of the companies’ control; Transaction
costs; actual or contingent liabilities; and other risks listed
under the heading “Risk Factors” in the Company’s periodic reports
filed with the U.S. Securities and Exchange Commission, including
current reports on Form 8-K, quarterly reports on Form 10-Q, annual
reports on Form 10-K, as well as the Schedule 14D-9 to be filed by
the Company and the Schedule TO and related tender offer documents
to be filed by Alfasigma and Interstellar Acquisition, Inc., a
wholly owned subsidiary of Alfasigma. You should not place undue
reliance on these statements. All forward-looking statements are
based on information currently available to the Company and
Alfasigma, and the Company and Alfasigma disclaim any obligation to
update the information contained in this communication as new
information becomes available.
Contacts
AlfasigmaCorporate CommunicationSimona Gelpi
simona.gelpi@alfasigma.comGea Gardini
gea.gardini@alfasigma.comwww.alfasigma.itiCorporateLuca Bolzoni
luca.bolzoni@icorporate.it
Intercept InvestorsNareg Sagherian, Executive Director, Global
Investor Relationsinvestors@interceptpharma.com
MediaMichael Blash, Senior Vice President, Corporate
Affairsmedia@interceptpharma.com
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