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Sanofi Active Ingredient Solutions cover both APIs sales & CDMO.
Lead Product(s): Efanesoctocog alfa
Therapeutic Area: Genetic Disease Product Name: BIVV001
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Bioverativ Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 18, 2021
Details:
Efanesoctocog alfa, previously known as BIVV001, is an investigational factor VIII replacement therapy that has the potential to transform therapy and provide high sustained factor activity levels for people with hemophilia A.
Sanofi Active Ingredient Solutions cover both APIs sales & CDMO.
Lead Product(s): Givosiran
Therapeutic Area: Genetic Disease Product Name: ALN-AT3SC
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 10, 2020
Details:
Sanofi will resume fitusiran dosing in ongoing U.S. adolescent and adult clinical studies. Fitusiran is an investigational, small interference RNA therapy in development for the treatment of people with hemophilia A or B, with or without inhibitors.
Sanofi Active Ingredient Solutions cover both APIs sales & CDMO.
Lead Product(s): Givosiran
Therapeutic Area: Genetic Disease Product Name: ALN-AT3SC
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 05, 2020
Details:
The WFH, EHC and NHF have learned of and subsequently confirmed a decision by Sanofi Genzyme to initiate a voluntary sponsor-led global dosing hold on its full clinical development program for fitusiran due to the identification of new adverse events.
Sanofi Active Ingredient Solutions cover both APIs sales & CDMO.
Lead Product(s): Avalglucosidase alfa
Therapeutic Area: Genetic Disease Product Name: GZ402666
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 02, 2020
Details:
The MAA is based on positive data from two trials: Phase 3, pivotal COMET trial, which evaluated the safety and efficacy of avalglucosidase alfa compared to alglucosidase alfa (standard of care) in patients with late-onset Pompe disease, and Phase 2 mini-COMET trial.
Sanofi Active Ingredient Solutions cover both APIs sales & CDMO.
Lead Product(s): Avalglucosidase alfa
Therapeutic Area: Genetic Disease Product Name: GZ402666
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 02, 2020
Details:
The MAA is based on positive data from two trials Phase 3 pivotal COMET trial, which evaluated the safety and efficacy of avalglucosidase alfa compared to alglucosidase alfa in patients with late-onset Pompe disease and Phase 2 mini-COMET trial.
Sanofi Active Ingredient Solutions cover both APIs sales & CDMO.
Lead Product(s): rFVIIIFc-VWF-XTEN
Therapeutic Area: Genetic Disease Product Name: BIVV001
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Swedish Orphan Biovitrum AB
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 10, 2020
Details:
BIVV001 is the first investigational factor VIII therapy independent of von Willebrand Factor and has the potential to transform replacement therapy for people with hemophilia A.
Sanofi Active Ingredient Solutions cover both APIs sales & CDMO.
Lead Product(s): rFVIIIFc-VWF-XTEN,Recombinant Antihemophilic Factor
Therapeutic Area: Genetic Disease Product Name: BIVV001
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2020
Details:
Presentations include findings on hemophilia and acquired thrombotic thrombocytopenic purpura portfolio therapies and pipeline candidates.
Sanofi Active Ingredient Solutions cover both APIs sales & CDMO.
Lead Product(s): Givosiran
Therapeutic Area: Genetic Disease Product Name: ALN-AT3SC
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 19, 2020
Details:
Long-term interim results from the Phase 2 open-label extension (OLE) study reinforce fitusiran’s potential to restore hemostatic balance and to lower annualized bleed rates (ABRs) over a period up to 57 months.
Sanofi Active Ingredient Solutions cover both APIs sales & CDMO.
Lead Product(s): Avalglucosidase alfa
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 16, 2020
Details:
Avalglucosidase alfa showed a 2.4-point improvement in percent-predicted forced vital capacity, an important measure of respiratory function in Pompe disease, compared to alglucosidase alfa (standard of care).
Sanofi Active Ingredient Solutions cover both APIs sales & CDMO.
Lead Product(s): Avalglucosidase alfa
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 08, 2020
Details:
Sanofi will host a virtual scientific session to present data from the Phase 3 COMET trial of investigational enzyme replacement therapy (ERT) avalglucosidase alfa in patients with late-onset Pompe disease (LOPD).
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