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Details:
Bylvay (odevixibat) is a potent, once-daily, non-systemic IBATi that acts locally in the small intestine and has minimal systemic exposure. It is approved in the U.S. for the treatment of pruritus due to Progressive Familial Intrahepatic Cholestasis.
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 13, 2023
Details:
Bylvay (odevixibat) is a potent, once-daily, non-systemic IBATi that acts locally in the small intestine and has minimal systemic exposure. It is approved in the U.S. for the treatment of Alagille syndrome.
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 23, 2023
Details:
Bylvay (odevixibat) is a potent, once-daily, non-systemic IBATi that acts locally in the small intestine and has minimal systemic exposure. It is approved in the U.S. for the treatment of Alagille syndrome.
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 July 21, 2023
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
Partner/Sponsor/Collaborator: Albireo Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 20, 2023
Details:
Bylvay (odevixibat) is a potent, once-daily, non-systemic IBATi that acts locally in the small intestine and has minimal systemic exposure. It is approved in the U.S. for the treatment of Alagille syndrome.
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 June 13, 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
Details:
Under the agreement with Albireo, Medison aims to commercialize Odevixibat in Canada and Israel, for the treatment of patients with cholestatic liver diseases. Odevixibat is approved in Europe as Bylvay® for the treatment of progressive familial intrahepatic cholestasis.
Lead Product(s): Odevixibat
Therapeutic Area: Genetic Disease Product Name: Bylvay
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Albireo Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership August 16, 2022
Details:
New analyses of PEDFIC Phase 3 trials show that patients whose pruritus improves on Bylvay® (odevixibat) also experience improvements in sleep, quality of life, serum bile acids and hepatic parameters.
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 June 23, 2022
Details:
Five abstracts accepted, long-term data confirmed durable efficacy with Bylvay™ (odevixibat), with demonstrated improvement in quality of life, growth, and sleep measurements, and hepatic biomarkers in children with all types of 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 June 08, 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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 07, 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 May 23, 2022
Details:
Bylvay is a potent, once-daily, non-systemic ileal bile acid transport inhibitor already approved in U.S. for treatment of pruritus in patients 3 months of age and older in all types of PFIC, and in Europe for treatment of all types of PFIC in patients aged 6 months or older.
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 March 29, 2022
Details:
PEDFIC 1 was the first pivotal Phase 3 study conducted in PFIC, which evaluated the efficacy and tolerability of Bylvay in reducing pruritus and serum bile acids in a randomized, placebo-controlled trial, and PEDFIC 2 is a long-term, open-label Phase 3 extension study.
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 December 13, 2021
Details:
Phase 3 Bylvay (odevixibat) data present long-term treatment benefits show evidence of improved liver function across PFIC types. Odevixibat is small molecule inhibitor of ileal bile acid transporter for treatment of pruritus in patients 3 months of age and older 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 October 15, 2021
Details:
This agreement exemplifies Albireo’s commitment to providing global availability of Bylvay, particularly in areas like Japan where high prevalence translates to a sizable number of patients who currently have no approved treatment option.
Lead Product(s): Odevixibat
Therapeutic Area: Genetic Disease Product Name: Bylvay
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Jadeite Medicines
Deal Size: $135.0 million Upfront Cash: $15.0 million
Deal Type: Licensing Agreement October 12, 2021
Details:
The Company received the voucher with the approval of Bylvay for the treatment of all types of progressive familial intrahepatic cholestasis. The proceeds will continue the mission to ensure that all children with PFIC in the U.S. and Europe will have access to Bylvay.
Lead Product(s): Odevixibat
Therapeutic Area: Genetic Disease Product Name: Bylvay
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Jefferies LLC
Deal Size: $105.0 million Upfront Cash: Undisclosed
Deal Type: Divestment September 07, 2021
Details:
The agreement with Genpharm advances Albireo’s global strategy for the commercialization of Bylvay in a key region following European and U.S. regulatory approvals of the use of Bylvay in patients with PFIC based on the PEDFIC study.
Lead Product(s): Odevixibat
Therapeutic Area: Genetic Disease Product Name: Bylvay
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Genpharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership August 18, 2021
Details:
PEDFIC 1 was the first and largest, global, pivotal Phase 3 study conducted in PFIC, which evaluated the efficacy and tolerability of Bylvay in reducing pruritus and serum bile acids in a randomized, double-blind, placebo-controlled trial.
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 June 10, 2021
Details:
PEDFIC 1 was the first and largest, global, pivotal Phase 3 study conducted in PFIC, which evaluated the efficacy and tolerability of Bylvay in reducing pruritus and serum bile acids in a randomized, double-blind, placebo-controlled trial.
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 June 03, 2021
Details:
Bylvay is an investigational product candidate being developed to treat rare pediatric cholestatic liver diseases, including PFIC, biliary atresia and ALGS. Data being presented show long-term benefits of Bylvay in children with 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 June 03, 2021
Details:
PEDFIC 2, a long-term, open-label Phase 3 extension study, reaffirmed Bylvay delivered sustained reductions in sBAs as well as improvements in pruritus assessments, growth and other markers of liver function in patients treated up to 48 weeks.
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 May 21, 2021
Details:
Odevixibat is a potent, once-daily, non-systemic ileal bile acid transport inhibitor being investigated for the treatment of rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis (PFIC), biliary atresia & Alagille syndrome (ALGS).
Lead Product(s): Odevixibat
Therapeutic Area: Genetic Disease Product Name: A4250
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 17, 2020
Details:
Odevixibat is a potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi) being developed to treat rare pediatric cholestatic liver diseases, including PFIC, biliary atresia and Alagille syndrome.
Lead Product(s): Odevixibat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: A4250
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 08, 2020
Details:
Three poster abstracts detailing exploratory analyses from Myokardia’s Phase 3 EXPLORER-HCM study of mavacamten were presented. Data from EXPLORER-HCM show Mavacamten improved cardiac structure and mitral valve function in obstructive hypertrophic cardiomyopathy patients.
Lead Product(s): Odevixibat
Therapeutic Area: Genetic Disease Product Name: A4250
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 13, 2020
Details:
Oral presentation of the results from PEDFIC 1, the global Phase 3 clinical trial evaluating the efficacy and safety of odevixibat in children with progressive familial intrahepatic cholestasis will be presented at the late-breaker session of the AASLD annual conference.
Lead Product(s): Odevixibat
Therapeutic Area: Genetic Disease Product Name: A4250
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, 2020
Details:
The company’s presentations will include studies on lead product candidate odevixibat, once-daily, non-systemic ileal bile acid transport inhibitor currently being developed to treat progressive familial intrahepatic cholestasis, biliary atresia and Alagille syndrome.
Lead Product(s): Odevixibat
Therapeutic Area: Genetic Disease Product Name: A4250
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 23, 2020
Details:
Odevixibat was well tolerated, with an overall adverse event incidence similar to placebo. There were no drug-related serious adverse events (SAEs) reported during the study.
Lead Product(s): Odevixibat
Therapeutic Area: Genetic Disease Product Name: A4250
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 08, 2020
Details:
Albireo’s lead candidate, odevixibat, is being developed to treat rare pediatric cholestatic liver diseases and is in Phase 3 development in progressive familial intrahepatic cholestasis and biliary atresia, with a third Phase 3 trial being planned in Alagille syndrome.
Lead Product(s): Odevixibat
Therapeutic Area: Genetic Disease Product Name: A4250
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 07, 2020
Details:
Program expands access to odevixibat for patients with progressive familial intrahepatic cholestasis (PFIC), an ultra-rare pediatric cholestatic liver disease.
Lead Product(s): Odevixibat
Therapeutic Area: Genetic Disease Product Name: A4250
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 20, 2020
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