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 M. Michelle Berrey, M.D., M.P.H., as
President of Research & Development and Chief Medical Officer.
“Dr. Berrey brings a wealth of leadership experience in drug
development and executive management to Intercept, and I am very
pleased to welcome her to the team,” said Jerry Durso, President
and Chief Executive Officer of Intercept. “She joins us at a
pivotal time for the company as we continue to drive our
foundational PBC business, advance our dialogue with regulatory
authorities on our NASH program, and build our pipeline. I would
also like to thank Dr. Gail Cawkwell, our Senior Vice President of
Medical Affairs, Safety & Pharmacovigilance, for her strong
leadership over the last several months as she took on additional
responsibilities as Acting Chief Medical Officer.”
Dr. Berrey was most recently President and Chief Executive
Officer at Chimerix and previously served as Chief Medical Officer
at Pharmasset from 2007 to 2012, prior to its acquisition by
Gilead. While at Pharmasset, she played a critical role in the
development of Sovaldi® (sofosbuvir), which established a
transformational new treatment paradigm for patients with hepatitis
C. Before joining Pharmasset, Dr. Berrey was Vice President, Viral
Diseases, Clinical Pharmacology & Discovery Medicine at
GlaxoSmithKline, where she was responsible for the early
development of compounds for the treatment of HIV, hepatitis
viruses and hepatic fibrosis. Dr. Berrey received her M.D. from the
Medical College of Georgia and a Master of Public Health from Emory
University.
“I am excited by this opportunity to help bring important
treatment options to people living with liver diseases,” said Dr.
Berrey. “Over the last five years, Intercept has changed the
treatment landscape for patients with primary biliary cholangitis,
a disease that had no new therapies for nearly two decades prior to
the approval of Ocaliva®. I look forward to helping the Intercept
R&D team continue to build on its strong legacy of clinical
research in liver disease.”
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
Statements
This 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 a 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, including in connection with the newly identified safety
signal relating to Ocaliva identified by the FDA in May 2020
and with respect to patients with PBC with decompensated cirrhosis,
a prior decompensation event or with compensated cirrhosis who have
evidence of portal hypertension; 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; the outcomes of ongoing discussions with the FDA
and European Medicines Agency regarding the feasibility
of the COBALT and 401 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 attract and
retain key personnel to manage our business effectively; 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, cash
equivalents and short-term investments; our ability to acquire,
license and invest in businesses, technologies, product candidates
and products; our ability to manage the growth of our operations,
infrastructure, personnel, systems and controls; our ability to
obtain and maintain adequate insurance coverage; continuing threats
from COVID-19, including additional waves of infections, and their
impacts including quarantines and other 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 and
facility closures or other restrictions, and the impact of the
foregoing on our results of operations and financial position; the
impact of general U.S. and foreign economic, industry,
market, regulatory or political conditions, including the 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, 2020.
CONTACT
For more information about Intercept, please contact:
Investorsinvestors@interceptpharma.com
Mediamedia@interceptpharma.com
Source: Intercept Pharmaceuticals, Inc.
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