NEW YORK, Jan. 27, 2021 (GLOBE NEWSWIRE) – Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapies to treat progressive non-viral liver disease, today announced that an analyst’s note commenting on the listing of Intercept’s product on the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) website reached a conclusion regarding the Status of a newly identified safety signal (NISS) for Ocaliva® (obeticholic acid) which the Company considers incorrect.
The FDA provides quarterly information on newly identified safety signals. The Company does not believe that the absence of a listed drug that appeared in a quarterly update in a subsequent quarter necessarily indicates that the FDA has completed its assessment of the NISS.
As Intercept previously disclosed, the Company has submitted a full safety assessment to the FDA and dialogue with the FDA regarding the NISS Agency’s assessment of Ocaliva continues.
As the Company also previously reported, the FDA notified Intercept in May 2020 that, as part of its routine post-market data safety oversight, the FDA began to assess an NISS for liver disorders. for Ocaliva which the FDA has classified as a potential risk, the lowest level of risk. According to FDA guidelines, this does not mean that the FDA has concluded that the drug has the listed risk or that it has identified a causal relationship between Ocaliva and the potential risk. The FDA has informed the Company that the FDA’s review of the NISS is focused on a subset of patients with cirrhotic or more advanced PBC who have taken Ocaliva.
About the interception
Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapies to treat progressive non-viral liver diseases, including primary biliary cholangitis (PBC) and non-alcoholic steatohepatitis (NASH). Founded in 2002 in New York, Intercept is present in the United States, Europe and Canada. For more information, please visit www.interceptpharma.com or connect with the company on Twitter and LinkedIn.
Caution 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 the timing or outcome of the evaluation of Food and US Drug Administration (FDA) regarding the newly identified safety signal, our clinical trials for the treatment of non-alcoholic 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 hepatic fibrosis due to NASH, the timing and acceptance of our regulatory filings and the potential approval of the OCA for hepatic fibrosis due to NASH, the review of our new drug application for OCA for the treatment of hepatic fibrosis due to NASH by the FDA, our intention to work with the FDA to resolve the issues raised in the Full Response Letter (CRL), the potential commercial success of the OCA, as well as our strategy, future operations, future funding. al position, future revenues, projected costs, financial directions, outlook, plans and goals. 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”, “” would “,” could “,” should “,” possible “,” continue “and similar expressions are intended to identify forward-looking statements, although all forward-looking statements do not 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 assume no obligation to update these forward-looking statements, except as required by law. . These forward-looking statements are based on estimates and assumptions of our management which, while 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 from those anticipated or predicted by our forward-looking statements: our ability to successfully market 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 quickly and inexpensively file and obtain regulatory approval of our product candidates on an expedited basis or not at all, including OCA for hepatic fibrosis due to NASH following CRL delivery by the FDA; any advisory committee recommendation or dispute resolution decision that our product candidates, including OCA for hepatic fibrosis due to NASH, should not be approved or approved only under certain conditions; any future determination that regulatory requests and subsequent information we submit for our product candidates, including OCA for hepatic fibrosis due to NASH, do not contain adequate clinical or other data or do not meet applicable regulatory requirements in terms of approval; conditions that may be imposed by regulatory authorities on our marketing authorizations for our products and product candidates, including OCA for hepatic fibrosis due to NASH, such as the need for clinical outcome data ( and not just results based on the achievement of a surrogate endpoint), any risk mitigation program such as a REMS, and any related restrictions, limitations and / or warnings contained in the label of one. our products or product candidates; any potential side effects associated with Ocaliva for CBP, OCA for hepatic fibrosis due to NASH or our other product candidates that could delay or prevent approval, require an approved product to be withdrawn from the market, require the inclusion of warnings or safety precautions, or otherwise restricting the sale of any such product or product candidate; the initiation, timing, cost, conduct, progress and results of our research and development, preclinical studies and clinical trials, including any problem, delay or failure in identifying patients, enrollment of patients, treatment of patients, retention of patients, meeting specific endpoints in the jurisdictions in which we intend to seek approval or complete and communicate in a timely manner 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 suppliers on whom we depend substantially for, among other things, the manufacture and supply of our products, including including Ocaliva for PBC and, if approved, OCA for hepatic fibrosis due to NASH, and our clinical trials activities; our ability to successfully identify, develop and market our products and product candidates, including our ability to successfully launch OCA for hepatic 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 profitably file, prosecute, defend and enforce any patent or other intellectual property right claims; the size and growth of 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 hepatic fibrosis due to NASH or our other product candidates among physicians, patients and payers of Health care ; the availability of adequate coverage and reimbursement from government and private health care payers for our products, including Ocaliva for PBC and, if approved, OCA for hepatic fibrosis due to NASH, and our ability to obtain adequate prices for these 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 breaches of data protection laws; the costs and results of any litigation, government inquiry or inquiry, regulatory proceeding, legal proceeding or litigation, including title, intellectual property, employment, product liability or other litigation; the election of our employees to pursue research, development and marketing activities; our ability to establish and maintain relationships with collaborators with expertise in development, regulation and marketing; our need and ability to generate or secure additional funding; our estimates of future expenses, income and capital requirements and their accuracy; 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 effectively run our business; our ability to manage the growth of our operations, infrastructure, people, systems and controls; our ability to obtain and maintain adequate insurance coverage; the impact of COVID-19, including any impact on our operating results or financial condition, quarantines and associated government actions, delays related to our regulatory applications, disruptions related to our ongoing clinical trials or involving our contracted research organizations, study sites or other clinical partners, disruptions related to our supply chain or involving our manufacturers, distributors or other third party distribution partners, facility closures or other restrictions, as well as their extent and their duration; the impact of economic, industrial, market, regulatory or general political conditions in the United States and abroad, including the potential impact of Brexit; and other risks and uncertainties identified in our periodic filings filed with the United States 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 closed quarter. September 30, 2020.
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Source: Intercept Pharmaceuticals, Inc.