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Kedrion
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400 Kelby Street 11th Floor Fort Lee, NJ 07024
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1-201-242-8900
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Details:

The commercial agreement includes potential expansion of Kedrion's distribution of Kedrab, a Human Rabies Immune Globulin, in additional territories beyond the US. In addition, the two companies will collaborate to expand distribution of Kedrion products by Kamada in Israel.


Lead Product(s): Rabies Immune Globulin (Human)

Therapeutic Area: Infections and Infectious Diseases Product Name: Kedrab

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Kamada

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement December 07, 2023

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The agreement aims for the distribution of Kedrab (Rabies Immune Globulin [Human]), which is indicated for passive, transient post-exposure prophylaxis of rabies infection to persons of all ages when given immediately after contact with a rabid, in the U.S.


Lead Product(s): Human Rabies Immune Globulin

Therapeutic Area: Immunology Product Name: Kedrab

Highest Development Status: ApprovedProduct Type: Large molecule

Recipient: Kamada

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement July 12, 2023

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With the acquisition of Prometic, Kedrion has finalized a series of transactions with the announcement that it was acquiring the plasma purification plant at Laval in Québec, and the license to distribute the new product called Ryplazim in the United States.


Lead Product(s): Plasminogen

Therapeutic Area: Rare Diseases and Disorders Product Name: Ryplazim

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Kedrion

Deal Size: $17.0 million Upfront Cash: Undisclosed

Deal Type: Acquisition October 18, 2021

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The primary efficacy objective of KIDCARES10 is to assess the efficacy of KIg10 administered to patients with PI to demonstrate that the rate of acute serious bacterial infections is less than 1.0 to provide substantial evidence of efficacy from day 1 to week 51/52.


Lead Product(s): Kedrion IVIG

Therapeutic Area: Immunology Product Name: KIg10

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 July 13, 2021

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This acquisition would include the Ryplazim® (plasminogen, human-tvmh) (“Ryplazim®”) business operated through its subsidiaries, Prometic Bioproduction Inc., the Company’s plasma-derived therapeutics manufacturing facility (“PBP”), and Prometic Biotherapeutics Inc.


Lead Product(s): Plasminogen

Therapeutic Area: Genetic Disease Product Name: Ryplazim

Highest Development Status: ApprovedProduct Type: Large molecule

Recipient: Prometic Biotherapeutic

Deal Size: $17.0 million Upfront Cash: Undisclosed

Deal Type: Agreement June 23, 2021

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Kedrion will enter into an option agreement with Liminal BioSciences to acquire the remainder of the company’s plasma-derived business, as well as Plasminogen business operated through its subsidiaries including Prometic Biotherapeutics which holds the BLA for Ryplazim.


Lead Product(s): Plasminogen

Therapeutic Area: Genetic Disease Product Name: Ryplazim

Highest Development Status: Phase IIIProduct Type: Large molecule

Recipient: Liminal BioSciences

Deal Size: $22.0 million Upfront Cash: Undisclosed

Deal Type: Acquisition May 17, 2021

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According to terms and conditions, the Option would grant Kedrion the right to acquire all of the shares of PBP and PBT and would entitle Liminal BioSciences to receive up to seventy percent of the net proceeds, if granted, associated with a potential FDA approval of Ryplazim.


Lead Product(s): Plasminogen

Therapeutic Area: Rare Diseases and Disorders Product Name: Ryplazim

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Kedrion

Deal Size: $17.0 million Upfront Cash: Undisclosed

Deal Type: Acquisition May 17, 2021

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Details:

Objectives of KIDCARES10 Study, a phase III, multi-center study are to assess the efficacy, safety, and pharmacokinetics of a 10 percent intravenous immunoglobulin (IVIG) in pediatric patients aged 2 to 17 years and affected by primary immunodeficiency disease (PI).


Lead Product(s): Kedrion IVIG

Therapeutic Area: Immunology Product Name: KIg10

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, 2021

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Details:

The study of KEDRAB® (Rabies Immune Globulin [Human]) conducted in children was the first and only pediatric study for any HRIG available in U.S. The study met its primary objective, which was to confirm the safety of KEDRAB in the pediatric population.


Lead Product(s): Rabies Immune Globulin [Human]

Therapeutic Area: Infections and Infectious Diseases Product Name: Kedrab

Highest Development Status: Phase IVProduct Type: Vaccine

Recipient: Kamada

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 19, 2020

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Kedrion will supply convalescent plasma from patients who have recovered from COVID-19 to be used for the manufacturing of IgG therapy. Columbia University will test the plasma against viral proteins to check the neutralizing power of the hyperimmune Immunoglobins.


Lead Product(s): Anti-COVID IgG therapy

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: PreclinicalProduct Type: Large molecule

Partner/Sponsor/Collaborator: Columbia University

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership July 21, 2020

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