Kamada Announces Availability of its Plasma-Derived Hyperimmune IgG Therapy for Coronavirus Disease (COVID-19) for Compassionate Use Treatment in Israel

• Kamada Completed Manufacturing and Released the First Batch of its Plasma-Derived Immunoglobulin Product for Coronavirus Disease (COVID-19) and it is Available for Compassionate Use Treatment in Israel; Additional Production is On-Going
  
• Kamada Intends to Initiate a Phase 1/2 Clinical Study in Hospitalized COVID-19 Patients in Israel During the Third Quarter of 2020
• Kamada and its Partner Kedrion are Expanding the Clinical Development Program to the U.S. and Expect to Hold a Pre-IND Meeting with the FDA Early in the Third Quarter of 2020
• Kamada Intends to Manufacture Future Batches of the Product using U.S. COVID-19 Convalescent Plasma Collected by Kedrion

REHOVOT, Israel, June 17, 2020 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a plasma-derived biopharmaceutical company, today provided an update on its development of a plasma-derived immunoglobulin (IgG) product for Coronavirus Disease (COVID-19).

Kamada completed manufacturing of the first batch of its plasma-derived IgG product for COVID-19 utilizing the Company’s approved proprietary IgG platform technology, and additional production is ongoing. The initial vials are available for compassionate use in Israel. In addition, Kamada’s proposed clinical protocol for a Phase 1/2 clinical trial was submitted to the Israeli Ministry of Health, and the Company expects to initiate the study during the third quarter of this year.

In order to expand its clinical development program to the U.S., Kamada, with the support of Kedrion Biopharma, intends to conduct a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) early in the third quarter in order to obtain FDA’s acceptance of the proposed clinical development program. Pursuant to the Company’s global collaboration agreement with Kedrion for the development, manufacturing and distribution of the plasma-derived IgG product for COVID-19, Kedrion is currently collecting COVID-19 convalescent plasma from U.S. recovered patients that will be used by Kamada to manufacture additional batches of the product. Kedrion is collecting the plasma, through its plasma business unit, KEDPLASMA, at 23 FDA-approved centers across the United States.