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Details:
Ocaliva (obeticholic acid) is a farnesoid X receptor (FXR) agonist, which is being evaluated for the treatment of individuals with primary biliary cholangitis.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 29, 2024
Details:
Through the acquisition, Alfasigma adds Ocaliva (obeticholic acid), a farnesoid X receptor agonist approved in the United States for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid in adults with an inadequate response to UDCA.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Alfasigma
Deal Size: $794.0 million Upfront Cash: $794.0 million
Deal Type: Acquisition November 08, 2023
Details:
Through the acquisition, Alfasigma adds Ocaliva (obeticholic acid), a farnesoid X receptor agonist approved in the United States for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid in adults with an inadequate response to UDCA.
Lead Product(s): Obeticholic Acid,Ursodeoxycholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Alfasigma
Deal Size: $794.0 million Upfront Cash: $794.0 million
Deal Type: Acquisition September 26, 2023
Details:
Ocaliva (obeticholic acid) is a FXR agonist, activating enterocytes and hepatocytes FXRs, thereby reducing toxic levels of bile acids and promoting insulin sensitivity. This results in low risk of lipid deposition into hepatocytes, reducing progression of NASH.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2023
Details:
Ocaliva (obeticholic acid) is a FXR agonist, activating enterocytes and hepatocytes FXRs, thereby reducing toxic levels of bile acids and promoting insulin sensitivity. This results in low risk of lipid deposition into hepatocytes, reducing progression of NASH.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 19, 2023
Details:
USFDA has granted orphan drug designation for the combination of ocaliva (obeticholic acid), a farnesoid X receptor agonist and bezafibrate, a PPAR agonist, for the treatment of individuals with primary biliary cholangitis.
Lead Product(s): Obeticholic Acid,Bezafibrate
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 16, 2023
Details:
Ocaliva (obeticholic acid) is a FXR agonist, activating enterocytes and hepatocytes FXRs, thereby reducing toxic levels of bile acids and promoting insulin sensitivity. This results in low risk of lipid deposition into hepatocytes, reducing progression of NASH.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 10, 2023
Details:
Ocaliva (obeticholic acid) is a FXR agonist, activating enterocytes and hepatocytes FXRs, thereby reducing toxic levels of bile acids and promoting insulin sensitivity. This results in low risk of lipid deposition into hepatocytes, reducing progression of NASH.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 19, 2023
Details:
Ocaliva (Obeticholic acid) is a FXR agonist, activating enterocytes and hepatocytes FXRs, thereby reducing toxic levels of bile acids and promoting insulin sensitivity. This results in low risk of lipid deposition into hepatocytes, reducing progression of NASH.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 04, 2023
Details:
A pre-specified interim analysis was conducted in 931 subjects who had a liver biopsy at Month 18 to assess the effect of Obeticholic Acid (Ocaliva) on liver histology as compared to baseline biopsies.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 23, 2022
Details:
OCALIVA, a farnesoid X receptor (FXR) agonist having obeticholic acid, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC).
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 08, 2022
Details:
Results showed INT-787 was generally well tolerated in healthy subjects. No serious adverse events were reported. The half-life of total INT-787 ranged from 20 to 43 hours in cohorts with robust exposure.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: INT-787
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 07, 2022
Details:
OCALIVA is a prescription medicine used to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well enough to UDCA, or alone for adults who cannot tolerate UDCA.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: INT-747
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 06, 2022
Details:
REVERSE, a Phase 3 study evaluating safety and efficacy of Ocaliva (obeticholic acid) in patients did not meet its primary endpoint of a ≥ 1-stage histological improvement in fibrosis with no worsening of NASH following up to 18 months of therapy.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 30, 2022
Details:
Ocaliva (obeticholic acid) 25 mg met the agreed primary endpoint of improvement in liver fibrosis without worsening of NASH at 18 months (p<0.0001), consistent with the original REGENERATE analysis.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 07, 2022
Details:
OCALIVA (obeticholic acid), a farnesoid X receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC). OCALIVA is contraindicated in PBC patients with decompensated cirrhosis.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Advanz Pharma
Deal Size: $450.0 million Upfront Cash: $405.0 million
Deal Type: Divestment July 01, 2022
Details:
Ocaliva® (obeticholic acid), a farnesoid X receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC). This indication is approved under accelerated approval based on a reduction in alkaline phosphatase.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 21, 2022
Details:
OCALIVA (Obeticholic Acid), a farnesoid X receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC).
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 06, 2022
Details:
COBALT study in advanced PBC, previously terminated early due to feasibility challenges, did not demonstrate a statistically significant difference in clinical endpoints between Ocaliva (obeticholic acid) and placebo.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 03, 2022
Details:
Agreement includes rights for Advanz to commercialize orphan drug Ocaliva® (Obeticholic Acid) for PBC outside the U.S., as well as the transition to Advanz of the international commercial and medical infrastructure of Intercept.
Lead Product(s): Obeticholic Acid,Ursodeoxycholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Advanz Pharma
Deal Size: $450.0 million Upfront Cash: $405.0 million
Deal Type: Acquisition May 05, 2022
Details:
A recent study evaluating Ocaliva® (obeticholic acid) in patients diagnosed with primary biliary cholangitis (PBC) revealed similar patient-reported adverse effects as in clinical trials while also exploring patient out-of-pocket cost and utilization.
Lead Product(s): Obeticholic Acid,Ursodeoxycholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Duquesne University School of Pharmacy
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2022
Details:
Company update that data from the Phase 3 REVERSE trial of Obeticholic acid is delayed and is expected in the first quarter of 2022. The primary endpoint is the percentage of patients with histological improvement in fibrosis by at least one stage with no worsening of NASH.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 20, 2021
Details:
OCALIVA® (obeticholic acid), a farnesoid X receptor agonist, is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA). It's withdrawl of Marketing Authorization Application (MAA) is based on phase 3 REGENERATE Study.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 09, 2021
Details:
Despite Intercept Pharmaceuticals’ obeticholic acid (OCA) having a stronger shot at its second attempt at approval in nonalcoholic steatohepatitis (NASH), experts are still cautious of its initial uptake prospects.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 17, 2021
Details:
The use of OCA for NASH is investigational and has not been approved by the U.S. Food and Drug Administration, the European Commission or any other health authority.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 21, 2021
Details:
REGENERATE is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study assessing the safety and efficacy of obeticholic acid (OCA) on clinical outcomes in patients with liver fibrosis due to NASH, an investigational use.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 2020
Details:
Presentations include Ocaliva efficacy and safety data in patients with PBC treated for up to six years, new data from the interim analysis of the Phase 3 REGENERATE study.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 29, 2020
Details:
Additional data indicate that obeticholic acid (OCA) helped patients with nonalcoholic steatohepatitis (NASH) achieve sustained improvements in liver biochemistry and noninvasive markers of liver fibrosis over two years of treatment.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 27, 2020
Details:
Viewing the evidence from the study as a whole, ICMR feels that the long-term net effects of OCA on quality of life and health of patients with NASH and F2/F3 fibrosis are uncertain.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: OCA
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 21, 2020
Details:
The U.S. F.D.A has determined that the predicted benefit of OCA based on a surrogate histopathologic endpoint remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients with liver fibrosis due to NASH.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2020
Details:
U.S.FDA has notified Intercept that its advisory committee meeting (AdCom) relating to the company’s new drug application (NDA) for obeticholic acid (OCA) for the treatment of liver fibrosis due to nonalcoholic steatohepatitis (NASH) has been postponed.
Lead Product(s): Obeticholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 22, 2020
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