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Find Approved Hematology Drugs in Clinical Development in UNITED STATES

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            Lead Product(s): Pegfilgrastim

            Therapeutic Area: Hematology Product Name: Nyvepria

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 11, 2020

            Details:

            The FDA approval was based on the review of a comprehensive data package and totality of evidence demonstrating a high degree of similarity of NYVEPRIA to its reference product.

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            Lead Product(s): Vadadustat

            Therapeutic Area: Hematology Product Name: Vafseo

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 23, 2020

            Details:

            PRO2TECT data show vadadustat achieved primary and key secondary efficacy endpoints in each study, but did not meet the primary safety endpoint.

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            Lead Product(s): Ravulizumab

            Therapeutic Area: Hematology Product Name: Ultomiris

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 12, 2020

            Details:

            ULTOMIRIS 100 mg/mL is an advancement in the treatment experience for patients with aHUS and PNH, as it reduces average annual infusion times by approximately 60 percent compared to ULTOMIRIS 10 mg/mL while delivering comparable safety and efficacy.

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            Lead Product(s): FERUMOXYTOL

            Therapeutic Area: Hematology Product Name: Feraheme

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: COVIS PHARMA

            Deal Size: $647.0 million Upfront Cash: $647.0 million

            Deal Type: Acquisition October 01, 2020

            Details:

            With this deal, Covis gains access to AMAG’s two commercial therapies, Makena, indicated for women with risk of preterm birth in singleton pregnancies and Feraheme indicated treat iron deficiency anaemia in CKD patients and for whom oral iron is not suitable or ineffective.

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            Lead Product(s): Luspatercept

            Therapeutic Area: Hematology Product Name: Reblozyl

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 29, 2020

            Details:

            Health Canada has approved REBLOZYL® (luspatercept) for the treatment of adult patients with red blood cell (RBC) transfusion-dependent anemia associated with beta(β)-thalassemia.

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            Lead Product(s): Ravulizumab

            Therapeutic Area: Hematology Product Name: Ultomiris

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 25, 2020

            Details:

            ULTOMIRIS is the first and only long-acting C5 inhibitor for aHUS and is administered every other month for adults and children (20 kg or more) and monthly for children (<20 kg).

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            Lead Product(s): Ravulizumab

            Therapeutic Area: Hematology Product Name: Ultomiris

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 21, 2020

            Details:

            ULTOMIRIS is the first and only long-acting C5 inhibitor administered every eight weeks for the treatment of two ultra-rare diseases—paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).

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            Lead Product(s): Vadadustat

            Therapeutic Area: Hematology Product Name: Vafseo

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 03, 2020

            Details:

            The Company's vadadustat development program also includes two other global Phase 3 studies (INNO2VATE) for the treatment of anemia due to CKD in adult patients on dialysis, for which the Company reported positive top-line data in May.

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            Lead Product(s): Ravulizumab

            Therapeutic Area: Hematology Product Name: Ultomiris

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 30, 2020

            Details:

            PNH with Extravascular Hemolysis (EVH): Alexion plans to initiate a Phase 3 study of ALXN2040 as an add-on therapy for PNH patients with EVH by the end of 2020.

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            Lead Product(s): Fostamatinib Disodium

            Therapeutic Area: Hematology Product Name: Tavalisse

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Grifols International

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 09, 2020

            Details:

            TAVLESSE, which is marketed in the U.S. under the brand name TAVALISSE®, is an oral spleen tyrosine kinase (SYK) inhibitor that targets the underlying autoimmune cause of ITP by impeding platelet destruction.

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