NEW YORK, March 10, 2021 (Globe NEWSWIRE) — Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical business concentrated on the advancement and commercialization of novel therapeutics to address progressive non-viral liver disorders, now announced that Sandip Kapadia, Chief Monetary Officer, will leave Intercept to go after a further chance. Mr. Kapadia will keep on to provide as Chief Money Officer till his departure on March 26, 2021. The Organization also introduced Mr. Rocco Venezia will be appointed Chief Accounting Officer and will serve as performing Chief Economical Officer until eventually a permanent substitute is declared.
“Sandip joined Intercept soon after the approval of Ocaliva in the U.S. and performed an essential position supporting the development of the Business from a medical phase to a business group,” stated Jerry Durso, President and Chief Govt Officer of Intercept. “On behalf of the Intercept staff, I want to thank Sandip for his contributions. Sandip has crafted a gifted and skilled crew at Intercept, and I’m really delighted to announce that Rocco Venezia will be appointed Chief Accounting Officer. Rocco has served as Intercept’s Controller due to the fact 2016 and provides more than 20 several years of suitable finance and accounting encounter to the job.”
“I want to thank my colleagues at Intercept for their partnership over the years as we constructed the Ocaliva franchise and innovative the NASH method to deliver important therapies to clients with non-viral liver ailments,” said Mr. Kapadia. “I’m assured the crew, below Jerry’s leadership, will carry on to reach its aims and provide long-term value to traders, healthcare providers and people.”
Mr. Kapadia’s departure is not associated to Intercept’s functions, economic reporting or controls and the Corporation reiterates its total 12 months 2021 economic assistance.
About Intercept
Intercept is a biopharmaceutical business focused on the enhancement and commercialization of novel therapeutics to take care of progressive non-viral liver disorders, which includes major biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH). Founded in 2002 in New York, Intercept has operations in the United States, Europe and Canada. For a lot more data, please pay a visit to www.interceptpharma.com or hook up with the enterprise on Twitter and LinkedIn.
Cautionary Be aware About Ahead-Wanting Statements
This press release contains ahead-searching statements, such as, but not confined to, statements with regards to the development, timing and effects of our scientific trials, such as our clinical trials for the therapy of nonalcoholic steatohepatitis (“NASH”), the protection and efficacy of our accredited product or service, Ocaliva (obeticholic acid or “OCA”) for primary biliary cholangitis (“PBC”), and our product candidates, including OCA for liver fibrosis thanks to NASH, the timing and acceptance of our regulatory filings and the possible approval of OCA for liver fibrosis thanks to NASH, the review of our New Drug Application for OCA for the treatment of liver fibrosis thanks to NASH by the U.S. Meals and Drug Administration (“FDA”), our intent to function with the Fda to tackle the difficulties lifted in a full reaction letter (“CRL”), the likely business good results of OCA, as properly as our technique, long run functions, long term money place, long run earnings, projected expenditures, economic steerage, potential clients, plans and targets.
These statements represent forward-looking statements inside the which means of Section 27A of the Securities Act of 1933, as amended, and Segment 21E of the Securities Trade Act of 1934, as amended. The phrases “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “possible,” “continue” and related expressions are meant to recognize forward-seeking statements, even though not all ahead-wanting statements have these figuring out words and phrases. Audience are cautioned not to spot undue reliance on these ahead-seeking statements, which communicate only as of the date of this release, and we undertake no obligation to update any ahead-looking assertion other than as required by legislation. These forward-seeking statements are primarily based on estimates and assumptions by our administration that, although believed to be realistic, are inherently uncertain and subject to a selection of threats.
The next symbolize some, but not automatically all, of the variables that could induce actual results to differ materially from historical benefits or these anticipated or predicted by our ahead-seeking statements: our capability to effectively commercialize Ocaliva for PBC our capacity to preserve our regulatory acceptance of Ocaliva for PBC in the United States, Europe, Canada, Israel, Australia and other jurisdictions in which we have or might obtain advertising and marketing authorization our capacity to well timed and charge-correctly file for and get regulatory approval of our product or service candidates on an accelerated foundation or at all, including OCA for liver fibrosis thanks to NASH subsequent the issuance of the CRL by the Food and drug administration any advisory committee advice or dispute resolution resolve that our products candidates, like OCA for liver fibrosis owing to NASH, should not be approved or permitted only underneath sure ailments any long term determination that the regulatory programs and subsequent information we submit for our product or service candidates, which include OCA for liver fibrosis due to NASH, do not have ample clinical or other details or meet relevant regulatory needs for acceptance problems that may be imposed by regulatory authorities on our advertising and marketing approvals for our products and solutions and solution candidates, together with OCA for liver fibrosis because of to NASH, this sort of as the need for medical outcomes data (and not just outcomes dependent on achievement of a surrogate endpoint), any danger mitigation courses these as a REMS, and any associated limitations, limits and/or warnings contained in the label of any of our merchandise or product or service candidates any potential aspect results related with Ocaliva for PBC, OCA for liver fibrosis because of to NASH or our other product candidates that could hold off or stop acceptance, call for that an permitted solution be taken off the market place, have to have the inclusion of basic safety warnings or safeguards, or or else restrict the sale of these types of products or product candidate, such as in relationship with the freshly identified security sign relating to Ocaliva recognized by the Fda in May possibly 2020 the initiation, timing, expense, carry out, development and effects of our research and improvement functions, preclinical scientific tests and scientific trials, together with any difficulties, delays or failures in determining sufferers, enrolling sufferers, managing patients, retaining clients, assembly precise endpoints in the jurisdictions in which we intend to look for approval or completing and well timed reporting the final results of our NASH or PBC clinical trials the results of ongoing conversations with the Food and drug administration and European Medications Company with regards to the feasibility of the COBALT and 401 trials our ability to build and maintain relationships with, and the effectiveness of, third-occasion makers, deal exploration businesses and other distributors on whom we are substantially dependent for, between other items, the manufacture and provide of our items, like Ocaliva for PBC and, if authorized, OCA for liver fibrosis because of to NASH, and our medical demo actions our potential to determine, produce and correctly commercialize our merchandise and product or service candidates, including our potential to correctly start OCA for liver fibrosis owing to NASH, if accredited our potential to get and retain mental property protection for our goods and item candidates, including our capacity to expense-proficiently file, prosecute, defend and enforce any patent promises or other intellectual assets rights the measurement and expansion of the markets for our products and solutions and products candidates and our capacity to provide individuals marketplaces the degree of industry acceptance of Ocaliva for PBC and, if accepted, OCA for liver fibrosis because of to NASH or our other item candidates between physicians, patients and healthcare payors the availability of sufficient coverage and reimbursement from governmental and private healthcare payors for our products and solutions, together with Ocaliva for PBC and, if authorised, OCA for liver fibrosis owing to NASH, and our means to obtain sufficient pricing for these products and solutions our means to create and retain powerful gross sales, advertising and marketing and distribution capabilities, either specifically or through collaborations with 3rd events competitiveness from existing medication or new prescription drugs that develop into out there our ability to protect against technique failures, information breaches or violations of knowledge safety legal guidelines costs and outcomes relating to any disputes, governmental inquiries or investigations, regulatory proceedings, legal proceedings or litigation, which include any securities, mental assets, work, merchandise legal responsibility or other litigation our collaborators’ election to pursue research, growth and commercialization functions our skill to set up and preserve interactions with collaborators with development, regulatory and commercialization experience our will need for and skill to deliver or get hold of added financing our estimates relating to foreseeable future fees, revenues and capital demands and the accuracy thereof our use of funds and quick-phrase investments our skill to obtain, license and make investments in companies, technologies, product or service candidates and solutions our ability to appeal to and keep important personnel to handle our small business properly our ability to handle the advancement of our functions, infrastructure, staff, systems and controls our skill to attain and sustain satisfactory insurance protection the influence of COVID-19, together with any influence on our outcomes of functions or money posture, relevant quarantines and govt actions, delays relating to our regulatory apps, disruptions relating to our ongoing clinical trials or involving our agreement exploration organizations, analyze sites or other medical partners, disruptions relating to our offer chain or involving our 3rd-get together companies, distributors or other distribution associates, facility closures or other restrictions, and the extent and duration thereof the effects of common U.S. and foreign economic, marketplace, marketplace, regulatory or political disorders, together with the opportunity impact of Brexit and the other dangers and uncertainties determined in our periodic filings filed with the U.S. Securities and Trade Fee, together with our Once-a-year Report on Variety 10-K for the calendar year finished December 31, 2020.
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Source: Intercept Prescription drugs, Inc.
