Bezafibrate

Intercept Presents New Data on the Results of OCA-Bezafibrate Combination Therapy in PBC After Six Months of Treatment in Late-Breaking Poster Presentation at EASL Congress 2024

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Mittwoch, Juni 5, 2024
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Results from the study show that six-month administration of OCA and bezafibrate has the potential to normalize multiple serum biomarkers associated with improved transplant-free and decompensation-free survival in PBC.

Key Points: 
  • Results from the study show that six-month administration of OCA and bezafibrate has the potential to normalize multiple serum biomarkers associated with improved transplant-free and decompensation-free survival in PBC.
  • “These data add to a growing body of evidence showing that the combination of OCA and bezafibrate may provide additive clinical efficacy and tolerability benefits in the treatment of PBC,” said David Jones, Professor of Liver Immunology, Newcastle University.
  • “This investigational, combination therapy is the first we’ve seen to induce biochemical remission – or normalization of multiple biomarkers – in the majority of patients, marking a potentially new standard for efficacy in PBC therapeutic development.
  • “These results show that OCA-bezafibrate combination therapy in PBC has the potential to normalize multiple serum biomarkers associated with improved transplant-free and decompensation-free survival,” said Sangeeta Sawhney, Senior Vice President and Head of U.S. Research & Development at Intercept.

Intercept Announces New Data to be Presented at the European Association for the Study of the Liver (EASL) Congress 2024

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Mittwoch, Mai 29, 2024
Patient, Primary biliary cholangitis, Hepatology, Ursodeoxycholic acid, EASL, Congress, Intercept Pharmaceuticals, Cirrhosis, Senior, PBC, Research, Abstract, Liver disease, Intercept, Biomarker, Alkaline phosphatase, Head, Therapy, Bezafibrate, Medical imaging

MORRISTOWN, N.J., May 29, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, today announced nine abstracts related to primary biliary cholangitis (PBC) and alcohol-related liver disease will be presented at EASL Congress 2024.

Key Points: 
  • MORRISTOWN, N.J., May 29, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, today announced nine abstracts related to primary biliary cholangitis (PBC) and alcohol-related liver disease will be presented at EASL Congress 2024.
  • The congress will be held from June 5-8 in Milan, Italy.
  • “We are thrilled to present our latest research in PBC at this year’s EASL Congress,” said Sangeeta Sawhney, Senior Vice President and Head of U.S. Research & Development at Intercept.
  • A full list of sessions at EASL Congress 2024 is available at www.easlcongress.eu .

Intercept Presents New Data Demonstrating the Impact of OCA-Bezafibrate Combination Therapy on ALP and Metabolic Outcomes After Six Months of Treatment at Digestive Disease Week® 2024

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Samstag, Mai 18, 2024
LDL, DDW, Patient, Primary biliary cholangitis, Hepatology, Ursodeoxycholic acid, OCA, Safety, Intercept Pharmaceuticals, Serum, PBC, MD, Harvard Medical School, Associate, UDCA, Gastrointestinal disease, Therapy, ALP, Bezafibrate, Pharmaceutical industry

MORRISTOWN, N.J., May 18, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, is presenting new data from a planned six-month analysis of its ongoing Phase 2 study 747-213 evaluating a fixed-dose combination of obeticholic acid (OCA) and bezafibrate in patients with primary biliary cholangitis (PBC) at Digestive Disease Week® (DDW) 2024 in Washington, D.C. Results from the study show that six-month administration of OCA and bezafibrate has the potential to normalize alkaline phosphatase (ALP), a serum biomarker of PBC-related liver damage that has been correlated with improved transplant-free and decompensation-free survival.

Key Points: 
  • Results from the study show that six-month administration of OCA and bezafibrate has the potential to normalize alkaline phosphatase (ALP), a serum biomarker of PBC-related liver damage that has been correlated with improved transplant-free and decompensation-free survival.
  • “I am encouraged by the findings from this six-month analysis of the fixed-dose combination of OCA and bezafibrate,” said Alan Bonder, MD, Medical Director of Liver Transplant, BIDMC, and Associate Professor of Medicine, Harvard Medical School.
  • The objectives of this study were to evaluate change in ALP from baseline to Month 6, as well as changes in lipid panel over the same time period.
  • We look forward to presenting these data in further depth at DDW 2024.”
    The company is continuing its two ongoing Phase 2 studies (747-213 / NCT04594694 , 747-214 / NCT05239468 ), which are exploring a range of therapeutic doses and formulations for the combination of OCA and bezafibrate.

Intercept Announces New PBC Data Analyses to be Presented at Digestive Disease Week® 2024 Conference

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Donnerstag, Mai 9, 2024
Bezafibrate, Gastrointestinal disease, Learning, Intercept, Abstract, Aspartic acid, Primary biliary cholangitis, Fibrosis, Intercept Pharmaceuticals, Therapy, Senior, Liver, Obeticholic acid, DDW, Hepatology, PBC, Risk, Head, Pharmaceutical industry

MORRISTOWN, N.J., May 09, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, today announced five abstracts on primary biliary cholangitis (PBC) will be presented at Digestive Disease Week® (DDW) 2024.

Key Points: 
  • MORRISTOWN, N.J., May 09, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, today announced five abstracts on primary biliary cholangitis (PBC) will be presented at Digestive Disease Week® (DDW) 2024.
  • “These data, along with new analyses from our landmark Phase 3 POISE trial, showcase our continued commitment to helping improve the lives of people living with PBC.
  • A full list of sessions at DDW 2024 is available at www.ddw.org .
  • Attendees of DDW can visit Intercept at booths #3741 and #3828 throughout the meeting.

Intercept Announces New Phase 2 Data Showing Significant Impact of OCA-Bezafibrate Combination on Normalization of Multiple Key Biomarkers of PBC-Induced Liver Damage at AASLD The Liver Meeting® 2023

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Montag, November 13, 2023
UDCA, Primary biliary cholangitis, Hypertension, ALP, Research and development, OCA, Obeticholic acid, Hepatology, ALT, Intercept Pharmaceuticals, Aes, Ursodeoxycholic acid, PBC, AASLD, Intercept, PPAR, FXR, Serum, Data analysis, Alanine transaminase, FDA, Liver, Alkaline phosphatase, Bezafibrate, GGT, Therapy, University, Development, Biomarker, Itch, Magnetic resonance, Safety, Pharmaceutical industry, Fused quartz, Medicine, Boston, Patient

These data will be presented on Monday, November 13, 2023, at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting® in Boston (poster #5019-C).

Key Points: 
  • These data will be presented on Monday, November 13, 2023, at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting® in Boston (poster #5019-C).
  • One severe TEAE (pruritus, OCA5/B100 IR) occurred in Study 214; no TEAEs led to study discontinuation in Study 214.
  • The Company expects to have the necessary data from the OCA-bezafibrate combination program to submit a request in 2023 for an End-of-Phase 2 meeting with the FDA.
  • These data include analyses from both Phase 2 studies, in addition to Phase 1 and preclinical data.

Alfasigma completes acquisition of Intercept Pharmaceuticals, Inc.

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Mittwoch, November 8, 2023
Bezafibrate, Gastroenterology, Obeticholic acid, FDA, Delaware General Corporation Law, Food, Tax, Medication, Intercept Pharmaceuticals, Intercept, Liver, Acquisition, PBC, Primary biliary cholangitis, Autoimmune disease, USD, Hepatology, Patient, DNA, Food and Drug Administration, Holding company, Pharmaceutical industry, Pamlab

BOLOGNA, Italy and MORRISTOWN, N.J., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Alfasigma S.p.A. (“Alfasigma”) and Intercept Pharmaceuticals, Inc. (“Intercept”) announced today the completion of the acquisition of Intercept by Alfasigma through its wholly owned subsidiary Interstellar Acquisition Inc.

Key Points: 
  • BOLOGNA, Italy and MORRISTOWN, N.J., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Alfasigma S.p.A. (“Alfasigma”) and Intercept Pharmaceuticals, Inc. (“Intercept”) announced today the completion of the acquisition of Intercept by Alfasigma through its wholly owned subsidiary Interstellar Acquisition Inc.
  • As a result of the transaction, Intercept has become a wholly owned subsidiary of Alfasigma, and the common stock of Intercept has ceased to be traded on the NASDAQ Stock Market.
  • Stefano Golinelli, Chairman of Alfasigma, commented: “At Alfasigma, the passion we have for Pharmaceuticals is in our DNA - and a driver for our ambitious international growth plans.
  • Francesco Balestrieri, CEO of Alfasigma, added: “Today, we complete a transformational acquisition which strongly aligns with our strategy of building a solid presence in gastroenterology and hepatology, Alfasigma’s core business areas.

Alfasigma completes acquisition of Intercept Pharmaceuticals, Inc.

Retrieved on: 
Mittwoch, November 8, 2023
Health, Other Health, Research, Pharmaceutical, Science, Biotechnology, Bezafibrate, Gastroenterology, Obeticholic acid, FDA, Delaware General Corporation Law, Food, Tax, Medication, Intercept Pharmaceuticals, Intercept, Liver, Acquisition, United, PBC, Primary biliary cholangitis, Autoimmune disease, USD, Hepatology, Patient, DNA, Food and Drug Administration, Holding company, Pharmaceutical industry, Pamlab

Alfasigma S.p.A. (“Alfasigma”) and Intercept Pharmaceuticals, Inc. ( “Intercept”) announced today the completion of the acquisition of Intercept by Alfasigma through its wholly owned subsidiary Interstellar Acquisition Inc.

Key Points: 
  • Alfasigma S.p.A. (“Alfasigma”) and Intercept Pharmaceuticals, Inc. ( “Intercept”) announced today the completion of the acquisition of Intercept by Alfasigma through its wholly owned subsidiary Interstellar Acquisition Inc.
  • As a result of the transaction, Intercept has become a wholly owned subsidiary of Alfasigma, and the common stock of Intercept has ceased to be traded on the NASDAQ Stock Market.
  • Stefano Golinelli, Chairman of Alfasigma, commented: “At Alfasigma, the passion we have for Pharmaceuticals is in our DNA - and a driver for our ambitious international growth plans.
  • Thus, we are delighted to announce the successful outcome of our tender offer for Intercept Pharmaceuticals, Inc.

Alfasigma to Acquire Intercept Pharmaceuticals for $19.00 per Share in Cash, Expanding the Global Footprint of Alfasigma Via a Leader in Rare and Serious Liver Diseases

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Dienstag, September 26, 2023
Slate, Intercept, Centerview Partners, Bezafibrate, Gastroenterology, Ursodeoxycholic acid, Hepatology, PJT Partners, PBC, Oliver Cromwell, Primary biliary cholangitis, Acquisition, Patient, Skadden, Arps, Slate, Meagher & Flom, Intercept Pharmaceuticals, Autoimmune disease, Hart–Scott–Rodino Antitrust Improvements Act, UDCA, Liver, R, FDA, Hand, Barclays, Risk management, Cryptocurrency, Pharmaceutical industry, Security (finance), Pamlab

The anticipated transaction will materially expand Alfasigma’s gastrointestinal and hepatology portfolio and its presence in the U.S. market.

Key Points: 
  • The anticipated transaction will materially expand Alfasigma’s gastrointestinal and hepatology portfolio and its presence in the U.S. market.
  • Ocaliva® is the only approved second-line therapy for PBC and has experienced double-digit year-over-year growth supported by an experienced specialty sales force and strong prescriber base.
  • Intercept also benefits from a broader clinical development pipeline anchored by a novel fixed-dose combination of obeticholic acid and bezafibrate in phase 2 trials for PBC.
  • PJT Partners is acting as exclusive financial advisor to Alfasigma and Sullivan & Cromwell LLP and Chiomenti Studio Legale as legal counsel to Alfasigma.

Intercept Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Business Updates

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Mittwoch, August 2, 2023
Intercept, Workforce, FXR, EASL, Bezafibrate, Therapy, NASH, Hepatology, Serum, PBC, Cholestasis, General Administration of Sport of China, Pharmacokinetics, Biomarker, Sale, Congress, Shanda, SAH, Patient, Intercept Pharmaceuticals, OCA, Mullard 5-10, Growth, Depreciation, Fatty liver disease, European Association for the Study of Diabetes, Research, FDA, Conference, Total, Safety, Pharmaceutical industry, Rare-earth element, Security (finance), Silviculture, Liver, FRESH, Obeticholic acid

Selling, general and administrative expenses increased to $53.3 million in the second quarter of 2023, from $40.0 million in the prior year quarter.

Key Points: 
  • Selling, general and administrative expenses increased to $53.3 million in the second quarter of 2023, from $40.0 million in the prior year quarter.
  • Research and development expenses decreased to $37.3 million in the second quarter of 2023, from $44.8 million in the prior year quarter.
  • In the second quarter 2023, Intercept reported a net loss from continuing operations of $5.8 million, a decrease compared to a net loss from continuing operations of $20.3 million in the second quarter 2022.
  • ET
    The conference call and webcast discussing the Company’s second quarter 2023 financial results will take place on August 2, 2023, at 8:30 a.m.

Intercept Announces Restructuring to Strengthen Focus on Rare and Serious Liver Diseases and Significantly Reduce Operating Expenses

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Freitag, Juni 23, 2023
Intercept, Workforce, FXR, Bezafibrate, NASH, Hepatology, Conference call, PBC, Food and Drug Administration, Sale, Wind, Primary biliary cholangitis, Intercept Pharmaceuticals, OCA, Growth, Fatty liver disease, European Association of Sugar Manufacturers, FDA, Obeticholic acid, Conference, Food, Pharmaceutical industry

ET

Key Points: 
  • ET
    MORRISTOWN, N.J., June 23, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT) today announced a restructuring to strengthen the Company’s focus on rare and serious liver diseases and significantly reduce operating expenses, including discontinuing all nonalcoholic steatohepatitis (NASH)-related investment.
  • Actions taken by Intercept to reduce its operating expenses are projected to result in a workforce reduction of approximately one third of the Company.
  • Intercept expects to initiate workforce reductions in the third quarter of 2023, with the vast majority completed by the end of 2023.
  • Intercept is targeting a net reduction in annual non-GAAP adjusted operating expenses of approximately $140 million.