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III"},{"orgOrder":0,"company":"CSL Behring","sponsor":"HCmed Innovations","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"HCmed Reaches Milestone in Immunoglobin Combination Product Development with CSL Behring","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2021","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"CSL Behring","sponsor":"Uniqure","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"uniQure and CSL Behring Announce Primary Endpoint Achieved in HOPE-B Pivotal Trial of Etranacogene Dezaparvovec Gene Therapy in Patients with Hemophilia B","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Cell and Gene 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S.C. Injection 2000,\u201d as a Medicine for Prevention of Acute Hereditary Angioedema (HAE) Attacks","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"CSL Behring","sponsor":"Orsini Specialty Pharmacy","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Orsini Specialty Pharmacy Selected by CSL Behring as a Limited Distribution Partner for HEMGENIX\u00ae, the First and Only Gene Therapy for Hemophilia B","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"CSL Behring","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"CSL Behring Receives FDA Approval for Hizentra\u00ae (Immune Globulin Subcutaneous [Human] 20% Liquid) 50mL Prefilled Syringe","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"CSL Behring","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"CSL Behring Announces the First Patient has Received FDA-Approved HEMGENIX\u00ae (etranacogene dezaparvovec-drlb) for Hemophilia B","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"Approved","date":"June 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"CSL Behring","sponsor":"Uniqure","pharmaFlowCategory":"D","amount":"$2,050.0 million","upfrontCash":"$450.0 million","newsHeadline":"uniQure Announces Achievement of $100 Million Milestone Related to Hemophilia B Gene Therapy","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"Approved","date":"June 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"CSL Behring","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"CSL Behring Demonstrates Continued Commitment to Alpha-1 Community with Addition of ZEMAIRA\u00ae [Alpha1-Proteinase Inhibitor (Human)] 4- and 5-Gram Vials","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals by CSL Behring
Zemaira (human alpha1-proteinase inhibitor) is a highly purified form of AAT (human) currently approved for chronic augmentation and maintenance therapy in adults with Alpha 1 Antitrypsin Deficiency and clinical evidence of emphysema.
Lead Product(s):
Human Alpha1-Proteinase Inhibitor
Hemgenix (etranacogene dezaparvovec-drlb) is an AAV5 based gene therapy designed to deliver a copy of a gene encoding hFIX-Padua. Its single IV infusion results in cell transduction and increase in circulating Factor IX activity in patients with Hemophilia B.
The licensing agreement provided CSL Behring with exclusive global rights to Hemgenix (etranacogene dezaparvovec), uniQure’s first approved gene therapy for hemophilia B in the United States, EU and European Economic Area, and the UK, for patients with hemophilia B.
Hizentra (immune globulin subcutaneous [human] 20% liquid) supplies a broad spectrum of opsonizing and neutralizing IgG antibodies against a wide variety of bacterial and viral agents. It is indicated primary immunodeficiency and maintenance therapy in adults with CIDP.
Hemgenix (etranacogene dezaparvovec-drlb) is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with Hemophilia B who Currently use Factor IX prophylaxis therapy, or Have current or historical life-threatening hemorrhage.
In the COMPACT study, acute HAE attacks were significantly lower in the "Berinert"(Lyophilized Human C1-esterase) 60 IU/kg group at 0.52 per month compared to 4.03 per month in the placebo group (p<0.001, mixed model).
Data from the largest gene therapy study in Hemophilia B to date shows that etranacogene dezaparvovec is statistically superior in reducing annualized bleeding rate compared to baseline FIX prophylactic therapy.
Largest gene therapy study in hemophilia B achieved primary endpoint of non-inferiority in annualized bleeding rate after stable FIX expression, assessed at 18 months following a single dose of AMT-061(etranacogene dezaparvovec).
CSL Behring partnered with HCmed to develop a combination product consisting of a plasma-derived immunoglobulin formulation (CSL787) administered via a customized version of the AdheResp nebulizer, HCmed's breath-actuated mesh nebulizer.
Lead Product(s):
Human Plasma-derived Polyvalent Immunoglobulin G
uniQure announced that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 for the global licensing agreement with CSL Behring for etranacogene dezaparvovec expired on May 5, 2021, and the agreement became fully effective on May 6, 2021.
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