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FDA Approved Bivigam (immune globulin intravenous, human), a plasma-derived, polyclonal, intravenous immune globulin, for the treatment of primary humoral immunodeficiency in pediatric patient aged 2 years or older.
Lead Product(s): Immune Globulin
Therapeutic Area: Immunology Product Name: Bivigam
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 December 12, 2023
Details:
BIVIGAM (immune globulin intravenous, human – 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). BIVIGAM was approved by the FDA in May 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI).
Lead Product(s): Human Immune Globulin
Therapeutic Area: Immunology Product Name: Bivigam
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 December 13, 2022
Details:
BIVIGAM (human immune globulin, 10% liquid) is indicated for the treatment of primary humoral immunodeficiency. This includes, the humoral immune defect in CVID, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and SCID.
Lead Product(s): Human Immune Globulin
Therapeutic Area: Immunology Product Name: Bivigam
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Raymond James & Associates
Deal Size: $69.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering December 09, 2022
Details:
BIVIGAM [Immune Globulin Intravenous (Human), 10% Liquid] is indicated for the treatment of primary humoral immunodeficiency (PI). This includes the humoral immune defect in CVID, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and SCID.
Lead Product(s): Human Immune Globulin
Therapeutic Area: Immunology Product Name: Bivigam
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Raymond James & Associates
Deal Size: $60.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering December 07, 2022
Details:
ASCENIV (immune globulin intravenous, human – slra 10% liquid) is a plasma-derived, polyclonal, intravenous IVIG, indicated for treatment of primary humoral immunodeficiency, also known as primary immune deficiency disease, in adults and adolescents.
Lead Product(s): Human Immune Globulin
Therapeutic Area: Immunology Product Name: Asceniv
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 April 01, 2022
Details:
Approval of 36-month shelf life encompasses all ASCENIV & BIVIGAM immune globulin (“IG”) drug product stored at 2-8°C, in all vial sizes, production scales as well as internal and external fill-finished drug product.
Lead Product(s): Human Immune Globulin
Therapeutic Area: Immunology Product Name: Asceniv
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 March 25, 2022
Details:
ADMA intends to use the net proceeds from this offering (i) to advance the commercial sales of its U.S. Food and Drug Administration (FDA)-approved products through the procurement of raw materials for the manufacturing of BIVIGAM and ASCENIV.
Lead Product(s): Immune Globulin (Human)
Therapeutic Area: Immunology Product Name: Bivigam
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Raymond James & Associates
Deal Size: $57.5 million Upfront Cash: Undisclosed
Deal Type: Public Offering October 25, 2021
Details:
ADMA intends to use the net proceeds from this offering to advance the commercial sales of its U.S. Food and Drug Administration (FDA)-approved products through the procurement of raw materials for the manufacturing of BIVIGAM® and ASCENIV™.
Lead Product(s): Immune Globulin (Human)
Therapeutic Area: Immunology Product Name: Bivigam
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Raymond James & Associates, Inc.
Deal Size: $50.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering October 21, 2021
Details:
ADMA intends to use the net proceeds from this offering (i) for the procurement of raw materials for the manufacturing of BIVIGAM and ASCENIV.
Lead Product(s): Human Immune Globulin
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Morgan Stanley
Deal Size: $94.6 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 24, 2020
Details:
ADMA intends to use the net proceeds to procure raw materials for the production of BIVIGAM and ASCENIV, to support their marketing and other corporate purposes.
Lead Product(s): Human Immune Globulin
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Morgan Stanley
Deal Size: $82.3 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 06, 2020