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 Jerome (Jerry) Durso, currently Chief Operating
Officer, will succeed Mark Pruzanski as President and Chief
Executive Officer, effective January 1, 2021. Mr. Durso will also
be appointed to the Board of Directors following the transition.
Dr. Pruzanski will remain with Intercept as a director on the Board
and retained advisor to the company.
Paolo Fundarò, Chairman of the Board of Directors, stated,
“During his nearly two decades at the helm since founding
Intercept, Mark has established the company as a pioneering leader
in non-viral liver disease. He has led the company through many
important milestones, including our IPO in 2012, the worldwide
approval and commercialization of Ocaliva for PBC – our first
marketed product – and the only successful Phase 3 NASH program to
date. We have been working closely together on planning a seamless
transition and will benefit from Mark’s continued involvement to
support the company’s future success.”
Mr. Fundarò continued, “Jerry has broad global leadership
experience, a proven track record of execution and strong
commercial expertise. He is well suited to lead the company going
forward as we focus on enhancing the growth of our foundational PBC
business, supporting our NASH regulatory process in the US and
Europe, and building our pipeline. As we enter this next phase of
the company’s trajectory, I am confident that this is the right
time to transition leadership responsibilities to Jerry.”
Dr. Pruzanski said, “It has been an enormous privilege to have
created and led Intercept for these many years, and I am proud of
all that we have accomplished driving science and innovation for
the benefit of patients suffering from liver disease. I am very
pleased to transition leadership of the company to Jerry, whose
experience and expertise position him extremely well to lead the
company into our next chapter. I look forward to being a resource
for Jerry, particularly on our global NASH program and pipeline
efforts, and remaining an active member of our Board. Finally, I
would like to express my sincere appreciation to all of our
employees for their tireless efforts, which have been – and will
continue to be – the key to our success in delivering pioneering
therapies to patients.”
“I am honored and proud to become Intercept’s next CEO,” said
Mr. Durso. “This is a pivotal time for the company as we advance
our foundational rare liver disease business and work towards the
potential resubmission of our NDA in NASH fibrosis. I am confident
that we will leverage our core strengths and capabilities across
the business to execute on plans for continued growth and
advancement of our pipeline to drive the future success of
Intercept. I look forward to leading our talented team as we
continue to build on our solid foundation to further our goals to
help patients living with serious liver diseases and deliver for
all of our stakeholders.”
Jerry Durso has served as Intercept’s Chief Operating Officer
since February 2017 and has played a critical leadership role in
all aspects of Intercept’s business globally, including the
continued growth of the PBC business in over 35 countries with more
than $310 million in revenues anticipated this year. Mr. Durso has
over 25 years of experience in building and leading commercial and
business operations in life sciences organizations both in the
United States and abroad. Prior to joining Intercept, he spent the
majority of his career at Sanofi, a global pharmaceutical company,
where he served as Senior Vice President, Chief Commercial Officer
of the Global Diabetes Division. Prior to that, Mr. Durso was
Senior Vice President, Chief Commercial Officer of Sanofi’s U.S.
pharmaceuticals business and also served in a number of commercial
leadership roles of increasing responsibility in business unit and
brand management, marketing and sales since he first joined Sanofi
in 1993.
About Intercept Intercept 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) and nonalcoholic steatohepatitis (NASH). Founded in 2002 in
New York, Intercept has operations in the United States, Europe and
Canada. For more information, please visit www.interceptpharma.com
or connect with the company on Twitter and LinkedIn.
Forward Looking StatementsThis press release
contains forward-looking statements, including, but not limited to,
statements regarding Dr. Pruzanski’s continued service as a
director of and advisor to Intercept, our future growth and plans,
including our focus on expanding our PBC business with Ocaliva,
supporting our NASH regulatory process with the FDA and potentially
resubmitting our NDA in NASH fibrosis and otherwise furthering our
product pipeline.
These statements constitute forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. The words “anticipate,” “believe,” “estimate,” “expect,”
“intend,” “may,” “plan,” “predict,” “project,” “target,”
“potential,” “will,” “would,” “could,” “should,” “possible,”
“continue” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Readers are cautioned
not to place undue reliance on these forward-looking statements,
which speak only as of the date of this release, and we undertake
no obligation to update any forward-looking statement except as
required by law. These forward-looking statements are based on
estimates and assumptions by our management that, although believed
to be reasonable, are inherently uncertain and subject to a number
of risks. The following represent some, but not necessarily all, of
the factors that could cause actual results to differ materially
from historical results or those anticipated or predicted by our
forward-looking statements: our ability to successfully
commercialize Ocaliva for PBC; our ability to maintain our
regulatory approval of Ocaliva for PBC in the United States,
Europe, Canada, Israel, Australia and other jurisdictions in which
we have or may receive marketing authorization; our ability to
timely and cost-effectively file for and obtain regulatory approval
of our product candidates on an accelerated basis or at all,
including OCA for liver fibrosis due to NASH following the issuance
of the CRL by the FDA; any advisory committee recommendation or
dispute resolution determination that our product candidates,
including OCA for liver fibrosis due to NASH, should not be
approved or approved only under certain conditions; any future
determination that the regulatory applications and subsequent
information we submit for our product candidates, including OCA for
liver fibrosis due to NASH, do not contain adequate clinical or
other data or meet applicable regulatory requirements for approval;
conditions that may be imposed by regulatory authorities on our
marketing approvals for our products and product candidates,
including OCA for liver fibrosis due to NASH, such as the need for
clinical outcomes data (and not just results based on achievement
of a surrogate endpoint), any risk mitigation programs such as a
REMS, and any related restrictions, limitations and/or warnings
contained in the label of any of our products or product
candidates; any potential side effects associated with Ocaliva for
PBC, OCA for liver fibrosis due to NASH or our other product
candidates that could delay or prevent approval, require that an
approved product be taken off the market, require the inclusion of
safety warnings or precautions, or otherwise limit the sale of such
product or product candidate; the initiation, timing, cost,
conduct, progress and results of our research and development
activities, preclinical studies and clinical trials, including any
issues, delays or failures in identifying patients, enrolling
patients, treating patients, retaining patients, meeting specific
endpoints in the jurisdictions in which we intend to seek approval
or completing and timely reporting the results of our NASH or PBC
clinical trials; our ability to establish and maintain
relationships with, and the performance of, third-party
manufacturers, contract research organizations and other vendors
upon whom we are substantially dependent for, among other things,
the manufacture and supply of our products, including Ocaliva for
PBC and, if approved, OCA for liver fibrosis due to NASH, and our
clinical trial activities; our ability to identify, develop and
successfully commercialize our products and product candidates,
including our ability to successfully launch OCA for liver fibrosis
due to NASH, if approved; our ability to obtain and maintain
intellectual property protection for our products and product
candidates, including our ability to cost-effectively file,
prosecute, defend and enforce any patent claims or other
intellectual property rights; the size and growth of the markets
for our products and product candidates and our ability to serve
those markets; the degree of market acceptance of Ocaliva for PBC
and, if approved, OCA for liver fibrosis due to NASH or our other
product candidates among physicians, patients and healthcare
payors; the availability of adequate coverage and reimbursement
from governmental and private healthcare payors for our products,
including Ocaliva for PBC and, if approved, OCA for liver fibrosis
due to NASH, and our ability to obtain adequate pricing for such
products; our ability to establish and maintain effective sales,
marketing and distribution capabilities, either directly or through
collaborations with third parties; competition from existing drugs
or new drugs that become available; our ability to prevent system
failures, data breaches or violations of data protection laws;
costs and outcomes relating to any disputes, governmental inquiries
or investigations, regulatory proceedings, legal proceedings or
litigation, including any securities, intellectual property,
employment, product liability or other litigation; our
collaborators’ election to pursue research, development and
commercialization activities; our ability to establish and maintain
relationships with collaborators with development, regulatory and
commercialization expertise; our need for and ability to generate
or obtain additional financing; our estimates regarding future
expenses, revenues and capital requirements and the accuracy
thereof; our use of cash and short-term investments; our ability to
acquire, license and invest in businesses, technologies, product
candidates and products; our ability to attract and retain key
personnel to manage our business effectively; our ability to manage
the growth of our operations, infrastructure, personnel, systems
and controls; our ability to obtain and maintain adequate insurance
coverage; the impact of COVID-19, including any impact on our
results of operations or financial position, related quarantines
and government actions, delays relating to our regulatory
applications, disruptions relating to our ongoing clinical trials
or involving our contract research organizations, study sites or
other clinical partners, disruptions relating to our supply chain
or involving our third-party manufacturers, distributors or other
distribution partners, facility closures or other restrictions, and
the extent and duration thereof; the impact of general U.S. and
foreign economic, industry, market, regulatory or political
conditions, including the potential impact of Brexit; and the other
risks and uncertainties identified in our periodic filings filed
with the U.S. Securities and Exchange Commission, including our
Annual Report on Form 10-K for the year ended December 31, 2019 and
our Quarterly Report on Form 10-Q for the quarter ended September
30, 2020.
ContactsFor more information
about Intercept, please contact:
Lisa DeFrancesco+1-646-565-4833investors@interceptpharma.com
Christopher Frates+1-646-757-2371media@interceptpharma.com
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