NEW YORK, Jan. 11, 2021 (GLOBE NEWSWIRE) — Intercept Prescription drugs, Inc. (Nasdaq:ICPT), a biopharmaceutical firm centered on the event and commercialization of novel therapeutics to deal with progressive non-viral liver illnesses, right now introduced the appointment of Jared M. Freedberg as Normal Counsel and Secretary. Mr. Freedberg joins Intercept from Immunomedics, Inc., which was acquired by Gilead Sciences in October of 2020.
“I’m very happy to welcome Jared to the Intercept crew as we start a pivotal 12 months for the corporate,” stated Jerry Durso, President and Chief Govt Officer of Intercept. “His substantial authorized and enterprise growth experience shall be invaluable as we concentrate on enhancing the expansion of our foundational PBC enterprise, supporting our NASH regulatory course of in the USA and Europe, and constructing our pipeline.”
Mr. Freedberg was beforehand Normal Counsel and Secretary and a member of the Govt Management Group for Immunomedics, with accountability for administration of all authorized actions, together with compliance, securities, company and board governance, contracting, IP technique and administration, enterprise growth and litigation administration. Whereas at Immunomedics, he was a part of a crew that efficiently guided the New Drug Software for Trodelvy™ from resubmission to approval. Previous to becoming a member of Immunomedics, Mr. Freedberg served as Normal Counsel, Specialty Generics Working Division, and Vice President, Enterprise Improvement and Licensing at Mallinckrodt Prescription drugs. From 2001-2016, he held positions of accelerating accountability at Covance Inc. and was a member of Covance’s World Govt Management Group as Head of Technique and Enterprise Improvement from 2014-2016, throughout which period he led the worldwide integration of LabCorp’s $6 billion acquisition of Covance.
“I’m thrilled to be becoming a member of Intercept due to the corporate’s distinctive concentrate on serving to sufferers with difficult liver illnesses which have restricted or no remedy choices,” stated Mr. Freedberg. “We now have an amazing alternative to construct on the corporate’s sturdy basis in 2021 and I stay up for being a part of a crew that can assist form the way forward for Intercept.”
Intercept is a biopharmaceutical firm centered on the event and commercialization of novel therapeutics to deal with progressive non-viral liver illnesses, together with main biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH). Based in 2002 in New York, Intercept has operations in the USA, Europe and Canada. For extra data, please go to www.interceptpharma.com or join with the corporate on Twitter and LinkedIn.
Cautionary Be aware Concerning Ahead-Trying Statements
This press launch incorporates forward-looking statements, together with, however not restricted to, statements relating to the progress, timing and outcomes of our medical trials, together with our medical trials for the remedy of nonalcoholic steatohepatitis (“NASH”), the security and efficacy of our authorized product, Ocaliva (obeticholic acid or “OCA”) for main biliary cholangitis (“PBC”), and our product candidates, together with OCA for liver fibrosis as a result of NASH, the timing and acceptance of our regulatory filings and the potential approval of OCA for liver fibrosis as a result of NASH, the assessment of our New Drug Software for OCA for the remedy of liver fibrosis as a result of NASH by the U.S. Meals and Drug Administration (FDA), our intent to work with the FDA to deal with the problems raised within the full response letter (CRL), the potential business success of OCA, in addition to our technique, future operations, future monetary place, future income, projected prices, monetary steerage, prospects, plans and goals. These statements represent forward-looking statements throughout the which means of Part 27A of the Securities Act of 1933, as amended, and Part 21E of the Securities Trade Act of 1934, as amended. The phrases “anticipate,” “imagine,” “estimate,” “anticipate,” “intend,” “could,” “plan,” “predict,” “mission,” “goal,” “potential,” “will,” “would,” “may,” “ought to,” “attainable,” “proceed” and related expressions are supposed to establish forward-looking statements, though not all forward-looking statements comprise these figuring out phrases. Readers are cautioned to not place undue reliance on these forward-looking statements, which converse solely as of the date of this launch, and we undertake no obligation to replace any forward-looking assertion besides as required by regulation. These forward-looking statements are based mostly on estimates and assumptions by our administration that, though believed to be cheap, are inherently unsure and topic to quite a few dangers. The next characterize some, however not essentially all, of the elements that might trigger precise outcomes to vary materially from historic outcomes or these anticipated or predicted by our forward-looking statements: our means to efficiently commercialize Ocaliva for PBC; our means to keep up our regulatory approval of Ocaliva for PBC in the USA, Europe, Canada, Israel, Australia and different jurisdictions by which we’ve or could obtain advertising and marketing authorization; our means to well timed and cost-effectively file for and acquire regulatory approval of our product candidates on an accelerated foundation or in any respect, together with OCA for liver fibrosis as a result of NASH following the issuance of the CRL by the FDA; any advisory committee advice or dispute decision dedication that our product candidates, together with OCA for liver fibrosis as a result of NASH, shouldn’t be authorized or authorized solely below sure situations; any future dedication that the regulatory functions and subsequent data we submit for our product candidates, together with OCA for liver fibrosis as a result of NASH, don’t comprise enough medical or different information or meet relevant regulatory necessities for approval; situations that could be imposed by regulatory authorities on our advertising and marketing approvals for our merchandise and product candidates, together with OCA for liver fibrosis as a result of NASH, corresponding to the necessity for medical outcomes information (and never simply outcomes based mostly on achievement of a surrogate endpoint), any danger mitigation applications corresponding to a REMS, and any associated restrictions, limitations and/or warnings contained within the label of any of our merchandise or product candidates; any potential uncomfortable side effects related to Ocaliva for PBC, OCA for liver fibrosis as a result of NASH or our different product candidates that might delay or stop approval, require that an authorized product be taken off the market, require the inclusion of security warnings or precautions, or in any other case restrict the sale of such product or product candidate; the initiation, timing, value, conduct, progress and outcomes of our analysis and growth actions, preclinical research and medical trials, together with any points, delays or failures in figuring out sufferers, enrolling sufferers, treating sufferers, retaining sufferers, assembly particular endpoints within the jurisdictions by which we intend to hunt approval or finishing and well timed reporting the outcomes of our NASH or PBC medical trials; our means to determine and keep relationships with, and the efficiency of, third-party producers, contract analysis organizations and different distributors upon whom we’re considerably dependent for, amongst different issues, the manufacture and provide of our merchandise, together with Ocaliva for PBC and, if authorized, OCA for liver fibrosis as a result of NASH, and our medical trial actions; our means to establish, develop and efficiently commercialize our merchandise and product candidates, together with our means to efficiently launch OCA for liver fibrosis as a result of NASH, if authorized; our means to acquire and keep mental property safety for our merchandise and product candidates, together with our means to cost-effectively file, prosecute, defend and implement any patent claims or different mental property rights; the scale and progress of the markets for our merchandise and product candidates and our means to serve these markets; the diploma of market acceptance of Ocaliva for PBC and, if authorized, OCA for liver fibrosis as a result of NASH or our different product candidates amongst physicians, sufferers and healthcare payors; the provision of enough protection and reimbursement from governmental and personal healthcare payors for our merchandise, together with Ocaliva for PBC and, if authorized, OCA for liver fibrosis as a result of NASH, and our means to acquire enough pricing for such merchandise; our means to determine and keep efficient gross sales, advertising and marketing and distribution capabilities, both instantly or via collaborations with third events; competitors from present medicine or new medicine that change into accessible; our means to forestall system failures, information breaches or violations of knowledge safety legal guidelines; prices and outcomes referring to any disputes, governmental inquiries or investigations, regulatory proceedings, authorized proceedings or litigation, together with any securities, mental property, employment, product legal responsibility or different litigation; our collaborators’ election to pursue analysis, growth and commercialization actions; our means to determine and keep relationships with collaborators with growth, regulatory and commercialization experience; our want for and talent to generate or receive extra financing; our estimates relating to future bills, revenues and capital necessities and the accuracy thereof; our use of money and short-term investments; our means to amass, license and put money into companies, applied sciences, product candidates and merchandise; our means to draw and retain key personnel to handle our enterprise successfully; our means to handle the expansion of our operations, infrastructure, personnel, programs and controls; our means to acquire and keep enough insurance coverage protection; the influence of COVID-19, together with any influence on our outcomes of operations or monetary place, associated quarantines and authorities actions, delays referring to our regulatory functions, disruptions referring to our ongoing medical trials or involving our contract analysis organizations, examine websites or different medical companions, disruptions referring to our provide chain or involving our third-party producers, distributors or different distribution companions, facility closures or different restrictions, and the extent and period thereof; the influence of normal U.S. and international financial, trade, market, regulatory or political situations, together with the potential influence of Brexit; and the opposite dangers and uncertainties recognized in our periodic filings filed with the U.S. Securities and Trade Fee, together with our Annual Report on Type 10-Ok for the 12 months ended December 31, 2019 and our Quarterly Report on Type 10-Q for the quarter ended September 30, 2020.
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Supply: Intercept Prescription drugs, Inc.