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Details:
Bylvay (Odevixibat) is theI BAT inhibitor and first drug approved in the U.S. for the treatment of pruritus in patients 3 months of age and older in all types of progressive familial intrahepatic cholestasis (PFIC).
Lead Product(s): Odevixibat
Therapeutic Area: Genetic Disease Product Name: Bylvay
Highest Development Status: ApprovedProduct Type: Small molecule
Recipient: Jadeite Medicines
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 20, 2023
Details:
The acquisition enriches Ipsen’s Rare Disease portfolio including Bylvay (odevixibat), a potent, non-systemic ileal bile-acid transport inhibitor (IBATi), for the treatment of pruritus in patients three months of age and older with PFIC.
Lead Product(s): Odevixibat
Therapeutic Area: Genetic Disease Product Name: Bylvay
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Ipsen
Deal Size: $952.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition March 03, 2023
Details:
Albireo’s pipeline includes Bylvay® (odevixibat), a potent, once-daily, oral, non-systemic ileal bile acid transport inhibitor. Bylvay is being investigated in biliary atresia, a severe and potentially fatal pediatric liver disease, in a pivotal Phase III clinical trial.
Lead Product(s): Odevixibat
Therapeutic Area: Genetic Disease Product Name: Bylvay
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Ipsen
Deal Size: $952.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition January 09, 2023
Details:
Bylvay (odevixibat) is used for the treatment of pruritus in patients 3 months of age and older in all types of PFIC. A potent, once-daily, non-systemic ileal bile acid transport inhibitor, Bylvay has minimal systemic exposure and acts locally in the small intestine.
Lead Product(s): Odevixibat
Therapeutic Area: Genetic Disease Product Name: Bylvay
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 30, 2022
Details:
A potent, once-daily, non-systemic ileal bile acid transport inhibitor, Bylvay (odevixibat) has minimal systemic exposure and acts locally in the small intestine. Bylvay can be taken as a capsule for patients that are able to swallow capsules.
Lead Product(s): Odevixibat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Bylvay
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 02, 2022
Details:
Bylvay® (odevixibat) is the first drug approved in the U.S. for the treatment of pruritus in patients 3 months of age and older in all types of progressive familial intrahepatic cholestasis (PFIC).
Lead Product(s): Odevixibat
Therapeutic Area: Genetic Disease Product Name: Bylvay
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 01, 2022
Details:
In primary analysis of Bylvay (odevixibat) study met primary endpoint showing statistically significant reduction in pruritus as measured by PRUCISION Observer-Reported Outcome scratching score, from baseline at month 6 (weeks 21 to 24), compared to placebo arm (p=0.002).
Lead Product(s): Odevixibat
Therapeutic Area: Genetic Disease Product Name: Bylvay
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 11, 2022
Details:
A potent, non-systemic ileal bile acid transport inhibitor, Bylvay (odevixibat) acts locally in the small intestine. Bylvay may not be effective in PFIC type 2 patients with ABCB11 variants resulting in non-functional or complete absence of bile salt export pump protein.
Lead Product(s): Odevixibat
Therapeutic Area: Genetic Disease Product Name: Bylvay
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 05, 2022
Details:
The agreement grants a first lien security interest on Albireo’s worldwide annual consolidated net revenues relating to Bylvay and associated additional collateral, and does not provide for liens on Albireo’s intellectual property.
Lead Product(s): Odevixibat
Therapeutic Area: Dermatology Product Name: Bylvay
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sagard
Deal Size: Undisclosed Upfront Cash: $115.0 million
Deal Type: Agreement September 22, 2022
Details:
Bylvay is the first drug approved in the U.S. for the treatment of pruritus in patients 3 months of age and older in all types of progressive familial intrahepatic cholestasis (PFIC).
Lead Product(s): Odevixibat
Therapeutic Area: Genetic Disease Product Name: Bylvay
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 06, 2022
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