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  • Development Update

Details:

Nucala (mepolizumab) is the first targeted anti-Interleukin-5 (IL-5) biologic. It is approved as an add-on maintenance treatment for severe eosinophilic asthma.


Lead Product(s): Mepolizumab

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Nucala

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 10, 2024

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  • Development Update

Details:

Nucala (mepolizumab) is the first-in-class monoclonal antibody to target IL-5. It is believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils, reducing blood eosinophils and maintaining them within normal levels.


Lead Product(s): Mepolizumab

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Nucala

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 01, 2023

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  • Development Update

Details:

Nucala (mepolizumab) is the first-in-class monoclonal antibody to target IL-5. It is believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils, reducing blood eosinophils and maintaining them within normal levels.


Lead Product(s): Mepolizumab

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Nucala

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 14, 2023

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Details:

BAT2606 a proposed biosimilar of Nucala® (mepolizumab) is an interleukin-5 (IL-5) antagonist mAB that is administered subcutaneously with a syringe or autoinjector for treatment of severe asthma, chronic rhinosinusitis with nasal, eosinophilic granulomatosis with polyangiitis.


Lead Product(s): Mepolizumab

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: BAT2606

Highest Development Status: Phase IProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 14, 2022

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  • Development Update

Details:

Nucala (mepolizumab) is the first-in-class monoclonal antibody targets IL-5 from binding to its receptor on the surface of eosinophils, reducing blood eosinophils and maintaining them within normal levels.


Lead Product(s): Mepolizumab

Therapeutic Area: Rare Diseases and Disorders Product Name: Nucala

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 17, 2021

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  • Development Update

Details:

NUCALA (mepolizumab) is a monoclonal antibody that works by blocking a specific protein called interleukin-5. This is the fourth approved indication for NUCALA for Canadian patients with eosinophilic driven diseases.


Lead Product(s): Mepolizumab

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Nucala

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 08, 2021

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  • Development Update

Details:

Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), for use in three eosinophil-driven diseases; hypereosinophilic syndrome (HES), eosinophilic granulomatosis with polyangiitis (EGPA) and chronic rhinosinusitis with nasal polyps (CRSwNP).


Lead Product(s): Mepolizumab

Therapeutic Area: Hematology Product Name: Nucala

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 17, 2021

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  • Development Update

Details:

Submissions based on positive data from pivotal studies in hypereosinophilic syndrome, chronic rhinosinusitis with nasal polyps and eosinophilic granulomatosis with polyangiitis.


Lead Product(s): Mepolizumab

Therapeutic Area: Rare Diseases and Disorders Product Name: Nucala

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 29, 2020

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  • Development Update

Details:

Nucala was evaluated in a randomized, double-blind, multicenter, placebo-controlled trial in 108 patients with HES. In the study, patients were randomly assigned to receive Nucala or placebo by injection every four weeks.


Lead Product(s): Mepolizumab

Therapeutic Area: Hematology Product Name: Nucala

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 25, 2020

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  • Development Update

Details:

If approval is obtained, it would make Nucala the first targeted biologic treatment for patients with this rare and life-threatening disease caused by eosinophilic inflammation.


Lead Product(s): Mepolizumab

Therapeutic Area: Hematology Product Name: Undisclosed

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 27, 2020

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  • Development Update

Details:

This is the first time an anti-IL5 biologic has reported positive phase 3 data in CRSwNP, and adds to the range of eosinophil-driven diseases in which Nucala has efficacious data.


Lead Product(s): Mepolizumab

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Undisclosed

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 03, 2020

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