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Anti-COVID-19 immunoglobulin - Kamada

Drug Profile

Anti-COVID-19 immunoglobulin - Kamada

Alternative Names: Anti-corona (COVID-19) hyperimmune polyclonal immunoglobulin - Kamada; Anti-Corona (COVID-19) IgG - Kamada; Anti-Corona (COVID-19) polyclonal immunoglobulin - Kamada; Plasma-derived Anti-SARS-CoV-2 IgG - Kamada

Latest Information Update: 30 Apr 2020

At a glance

  • Originator Kamada
  • Class Antivirals; Immunoglobulins; Polyclonal antibodies
  • Mechanism of Action Immunomodulators
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Research COVID 2019 infections

Most Recent Events

  • 27 Apr 2020 Anti-corona (COVID-19) polyclonal immunoglobulin (IgG) market licensed to China (Comarket licensee with Kamada), USA, Australia, Europe and South Korea
  • 11 Mar 2020 Early research in COVID-2019 infections in Israel (Parenteral)

Development Overview

Introduction

Anti-corona (COVID-19) polyclonal immunoglobulin (IgG) is being developed by Kamada, for the treatment of COVID-2019 infections. The hyperimmune IgG will be produced from plasma derived from donors recovered from the virus, anticipating to include antibodies to the novel Corona virus (COVID-19). The IgG is produced using the company's proprietary plasma derived IgG platform technology. Early research is underway in Israel.

Company Agreements

In April 2020, Kamada and Kedrion Biopharma, entered into a global collaboration for the development, manufacturing and distribution of a human plasma-COVID-19 polyclonal immunoglobulin (IgG) product for treatment of coronavirus. The initial primary focus of the collaboration is to provide the product as treatment to patients in Italy, Israel and the U.S. through various clinical programs, while subsequently expanding development and commercialization efforts to additional markets. As per the agreement terms, Kedrion will provide plasma, collected at its KEDPLASMA centers, from donors who have recovered from the virus and, upon receipt of regulatory approvals, will be responsible for commercialisation of the product in the US., Europe, Australia, and South Korea. Kamada will responsible for product development, manufacturing, clinical development, with Kedrion’s support, and regulatory submissions. Kamada will also assume distribution responsibility in all territories outside of those Kedrion is responsible for. Marketing rights for the product in China will be shared by the parties. [1]

Key Development Milestones

As of March 2020, early research of the anti-corona (COVID-19) polyclonal immunoglobulin is underway in Israel [2] .

Kamada has emphasised that the development plan and manufacturing of the product are highly dependent on the availability of hyperimmune plasma and on the regulatory path to be defined with the health authorities [2] .

Drug Properties & Chemical Synopsis

  • Route of administration Parenteral
  • Formulation unspecified
  • Class Antivirals, Immunoglobulins, Polyclonal antibodies
  • Mechanism of Action Immunomodulators
  • WHO ATC code

    J06B-C (Other immunoglobulins)

  • EPhMRA code

    J6H (Specific Immunoglobulins - Antiviral)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - - Research Israel Parenteral / unspecified Kamada 11 Mar 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Kamada Originator Israel
Kamada Owner Israel
Kedrion Biopharma Market Licensee Australia, China, Europe, South Korea, USA

Development History

Event Date Update Type Comment
27 Apr 2020 Licensing Status Anti-corona (COVID-19) polyclonal immunoglobulin (IgG) market licensed to China (Comarket licensee with Kamada), USA, Australia, Europe and South Korea [1] Updated 30 Apr 2020
11 Mar 2020 Phase Change Early research in COVID-2019 infections in Israel (Parenteral) [2] Updated 19 Mar 2020

References

  1. Kamada and Kedrion Biopharma Announce Global Collaboration for the Development, Manufacturing and Distribution of a Plasma-Derived Anti-SARS-CoV-2 (COVID-19) Polyclonal Immunoglobulin Product.

    Media Release
  2. Kamada Provides Update on Progress Related to its Proprietary Hyper-Immunoglobulin (IgGs) Platform Technology including its Commercial Anti-Rabies IgG and its Pipeline Products Anti-Corona (COVID-19) and Anti-Zika IgGs.

    Media Release
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