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Details:

Danicopan is an investigational oral medicine in development as an add-on to C5 inhibitor therapy eculizumab or ravulizumab for patients with paroxysmal nocturnal hemoglobinuria (PNH) who experience clinically significant extravascular haemolysis.


Lead Product(s): Danicopan,Ravulizumab,Eculizumab

Therapeutic Area: Rare Diseases and Disorders Product Name: ALXN2040

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 11, 2023

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Soliris (eculizumab) is a first-in-class C5 complement inhibitor and is approved in Japan for the treatment of adults with Neuromyelitis Optica Spectrum Disorder.


Lead Product(s): Eculizumab

Therapeutic Area: Immunology Product Name: Soliris

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 18, 2023

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Soliris (eculizumab) is a first-in-class C5 complement inhibitor and is approved in Japan for the treatment of adults with refractory generalised myasthenia gravis.


Lead Product(s): Eculizumab

Therapeutic Area: Immunology Product Name: Soliris

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 24, 2023

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Soliris (eculizumab) is a first-in-class C5 complement inhibitor and is approved in China for the treatment of adults with refractory generalised myasthenia gravis.


Lead Product(s): Eculizumab

Therapeutic Area: Immunology Product Name: Soliris

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 27, 2023

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Soliris (eculizumab) is a first-in-class C5 complement inhibitor and approved in China for the treatment of adults with refractory generalised myasthenia gravis.


Lead Product(s): Eculizumab

Therapeutic Area: Immunology Product Name: Soliris

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 26, 2023

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Soliris (eculizumab) is a first-in-class C5 complement inhibitor and approved in China for the treatment of adults with refractory generalised myasthenia gravis.


Lead Product(s): Eculizumab

Therapeutic Area: Immunology Product Name: Soliris

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 13, 2023

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ALXN2040 (danicopan) is an investigational oral medicine in development as an add-on to standard of care C5 inhibitor therapy Ultomiris (ravulizumab) or Soliris (eculizumab) for patients with PNH who experience clinically significant EVH.


Lead Product(s): Danicopan,Eculizumab,Ravulizumab

Therapeutic Area: Rare Diseases and Disorders Product Name: ALXN2040

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Alexion Pharmaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 09, 2023

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Epysqli™ (eculizumab) is a mAb that specifically binds to the complement protein C5, thereby inhibiting its cleavage to C5a and C5b and preventing the generation of the terminal complement complex C5b-9 mediated intravascular hemolysis in PNH patients.


Lead Product(s): Eculizumab

Therapeutic Area: Rare Diseases and Disorders Product Name: Epysqli

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 March 31, 2023

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Soliris (eculizumab) is a first-in-class C5 complement inhibitor. The medication works by inhibiting the C5 protein in the terminal complement cascade, a part of the body’s immune system.


Lead Product(s): Eculizumab

Therapeutic Area: Rare Diseases and Disorders Product Name: Soliris

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 11, 2022

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The study met its primary endpoints, demonstrating no clinically meaningful differences between ABP 959 (eculizumab) and SOLIRIS based on control of intravascular hemolysis as measured by lactate dehydrogenase (LDH) at week 27 for the parallel comparison.


Lead Product(s): Eculizumab

Therapeutic Area: Rare Diseases and Disorders Product Name: ABP 959

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 August 23, 2022

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Phase 3 study demonstrated clinical equivalence in efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of SB12 compared to reference eculizumab in paroxysmal nocturnal hemoglobinuria patients.


Lead Product(s): Eculizumab

Therapeutic Area: Immunology Product Name: SB12

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 June 10, 2022

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AstraZeneca's acquisition of Alexion, with its strong commercial portfolio and robust pipeline, will support its long-term ambition to develop novel medicines, which includes Soliris, in areas of immunology with high unmet medical needs.


Lead Product(s): Eculizumab

Therapeutic Area: Immunology Product Name: Soliris

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: AstraZeneca

Deal Size: $39,000.0 million Upfront Cash: $13,300.0 million

Deal Type: Acquisition July 21, 2021

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AstraZeneca's acquisition of Alexion, with its strong commercial portfolio and robust pipeline, will support its long-term ambition to develop novel medicines in areas of immunology with high unmet medical needs.


Lead Product(s): Eculizumab

Therapeutic Area: Immunology Product Name: Soliris

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: AstraZeneca

Deal Size: $39,000.0 million Upfront Cash: $13,300.0 million

Deal Type: Acquisition December 12, 2020

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While there are no data supporting the role of terminal complement in coronaviral pneumoni, company sees the use of SOLIRIS® in patients with coronaviral infection with severe pneumonia or ARDS.


Lead Product(s): Eculizumab

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: UndisclosedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 24, 2020

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To date, SB12 (AMT904) is the only biosimilar candidate referencing Soliris® (eculizumab) to be granted IND approval in China.


Lead Product(s): Eculizumab

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 January 09, 2020

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