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 the appointment of Jared M. Freedberg as General Counsel
and Secretary. Mr. Freedberg joins Intercept from Immunomedics,
Inc., which was acquired by Gilead Sciences in October of 2020.
“I am very pleased to welcome Jared to the Intercept team as we
begin a pivotal year for the company,” said Jerry Durso, President
and Chief Executive Officer of Intercept. “His substantial legal
and business development expertise will be invaluable as we focus
on enhancing the growth of our foundational PBC business,
supporting our NASH regulatory process in the United States and
Europe, and building our pipeline.”
Mr. Freedberg was previously General Counsel and Secretary and a
member of the Executive Leadership Team for Immunomedics, with
responsibility for management of all legal activities, including
compliance, securities, corporate and board governance,
contracting, IP strategy and management, business development and
litigation management. While at Immunomedics, he was part of a team
that successfully guided the New Drug Application for
Trodelvy™ from resubmission to approval. Prior to joining
Immunomedics, Mr. Freedberg served as General Counsel, Specialty
Generics Operating Division, and Vice President, Business
Development and Licensing at Mallinckrodt Pharmaceuticals. From
2001-2016, he held positions of increasing responsibility at
Covance Inc. and was a member of Covance's Global Executive
Leadership Team as Head of Strategy and Business Development from
2014-2016, during which time he led the global integration of
LabCorp’s $6 billion acquisition of Covance.
“I am thrilled to be joining Intercept because of the company’s
unique focus on helping patients with challenging liver diseases
that have limited or no treatment options,” said Mr. Freedberg. “We
have a tremendous opportunity to build on the company’s strong
foundation in 2021 and I look forward to being part of a team that
will help shape the future of Intercept.”
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) 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.
Cautionary Note Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements, including, but not limited to, statements regarding the
progress, timing and results of our clinical trials, including our
clinical trials for the treatment of nonalcoholic steatohepatitis
(“NASH”), the safety and efficacy of our approved product, Ocaliva
(obeticholic acid or “OCA”) for primary biliary cholangitis
(“PBC”), and our product candidates, including OCA for liver
fibrosis due to NASH, the timing and acceptance of our regulatory
filings and the potential approval of OCA for liver fibrosis due to
NASH, the review of our New Drug Application for OCA for the
treatment of liver fibrosis due to NASH by the U.S. Food and
Drug Administration (FDA), our intent to work with the FDA to
address the issues raised in the complete response letter (CRL),
the potential commercial success of OCA, as well as our strategy,
future operations, future financial position, future revenue,
projected costs, financial guidance, prospects, plans and
objectives. 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.
CONTACT
For more information about Intercept, please contact:
Lisa
DeFrancesco +1-646-565-4833 investors@interceptpharma.com
Christopher
Frates +1-646-757-2371 media@interceptpharma.com
Source: Intercept Pharmaceuticals, Inc.
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