Kamada Anti-SARS-CoV-2 / Kedrion, Kamada - LARVOL DELTA

Israel's Kamada forges ahead with development of new anti-Covid immunoglobulin therapy in partnership with Kedrion Biopharma of Italy (PRNewswire) - "...Kamada and its Italian partner Kedrion Biopharma are forging ahead with the development of a new anti-Covid therapy derived from the plasma of convalescent patients. The therapy is already being used in Israel. The Kamada CEO, in an interview with the Milan-based Le Fonti TV, said on Tuesday that he hoped that discussions with various health authorities and regulators around the world would soon help make available the new therapy in other countries....Kamada has been working with Israel's health ministry in recent months and now offers the therapy in Israel to treat Covid-19 patients."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease

Kamada Announces Top-line Results from its Phase 1/2 Clinical Trial of its Plasma-Derived Hyperimmune Globulin (IgG) Treatment for Coronavirus Disease (COVID-19) (GlobeNewswire) - P1/2, N=12; NCT04550325; Sponsor: Kamada, Ltd.; "Kamada Ltd....announced top-line results from its Phase 1/2 open-label, single-arm, multi-center clinical trial in Israel...11 of the 12 patients recovered following receipt of the treatment. Seven patients were discharged from the hospital at or before day 5 post-treatment and the remaining four patients were discharged by day 9. Following the infusion of the product anti-SARS CoV-2 IgG levels in the plasma of all patients increased...In January 2021, the Israeli Ministry of Health (IMOH) initiated a multi-center clinical study of Kamada's COVID-19 IgG product....To date more than 100 patients were enrolled into this study....'We will evaluate the results of the ongoing multi-center clinical study being conducted by the IMOH, which are expected later in 2021'."

Clinical data • Enrollment status • P1/2 data • Infectious Disease • Novel Coronavirus Disease

Kamada Reports Fourth Quarter and Fiscal Year 2020 Financial Results, Recent Achievements and Corporate Development Activities (GlobeNewswire) - "Israeli Ministry of Health (IMOH) Initiated Treatment of Hospitalized COVID-19 Patients with Kamada’s Plasma-Derived COVID-19 Immunoglobulin (IgG) Investigational Product Primarily as Part of a Multi-Center Clinical Study Led by the IMOH; Current Planned Supply to IMOH is Sufficient to Treat an Estimated 500 Patients."

Trial status • Infectious Disease • Novel Coronavirus Disease

Kamada Acquires FDA-Licensed Plasma Collection Center from Blood and Plasma Research, Inc. in Texas, USA (GlobeNewswire) - "Kamada Ltd....announced that it has entered into an agreement for the acquisition of the plasma collection center and certain related rights and assets from the privately-held Blood and Plasma Research, Inc...'Our increased focus on anti-D sales internationally, and the rapid development and supply of our investigational COVID-19 IgG product, we are committed to growing our hyperimmune IgG portfolio'....The acquisition for a total consideration of approximately $1.63 million, is expected to be consummated during this quarter, subject to closing conditions as set forth in the acquisition agreement..."

M&A • Infectious Disease • Novel Coronavirus Disease

Safety, PK and PD of Kamada Anti-SARS-CoV-2 in COVID-19 (clinicaltrials.gov) - P1/2; N=12; Completed; Sponsor: Kamada, Ltd.; Recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • PCR

Kamada Announces Supply Agreement with Israeli Ministry of Health for its Investigational IgG Product for COVID-19; Initial Order Expected to Generate $3.4 Million in Revenue in First Quarter of 2021 (GlobeNewswire) - "Kamada Ltd....today announced that it has signed an agreement with the Israeli Ministry of Health (MoH) to supply its anti-SARS-CoV-2 plasma-derived hyperimmune immunoglobulin....The initial order, planned to be supplied during the beginning of 2021, is sufficient to treat approximately 500 hospitalized patients. This initial supply is expected to generate approximately $3.4 million in revenue....The companies’ U.S. clinical development of a plasma-derived IgG product as a potential COVID-19 treatment is expected to begin in early 2021 pending IND acceptance."

Clinical • Commercial • Infectious Disease • Novel Coronavirus Disease

Safety, PK and PD of Kamada Anti-SARS-CoV-2 in COVID-19 (clinicaltrials.gov) - P1/2; N=12; Recruiting; Sponsor: Kamada, Ltd.

Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Kamada Announces Completion of Enrollment and Initial Interim Results from its Phase 1/2 Clinical Trial in Israel of its Plasma-Derived Hyperimmune Immunoglobulin (IgG) Product as a Potential Treatment for Coronavirus Disease (COVID-19) (GlobeNewswire) - P1/2, N=12; "Symptoms Improvement Observed in 11 of the 12 Patients within 24 to 48 Hours of Treatment; IgG Product Demonstrated Favorable Safety Profile to Date; Top-Line Results Expected to be Available by January of 2021; Kamada Ltd....announced the completion of enrollment and initial interim results...of the Company’s anti-SARS-CoV-2 plasma-derived hyperimmune immunoglobulin....With Kedrion’s support, Kamada submitted a pre-Investigational New Drug (IND) information package to the U.S. FDA, with its proposed U.S clinical development plan, FDA’s response is expected next month."

Enrollment closed • FDA event • P1/2 data • Infectious Disease • Novel Coronavirus Disease

Kamada Reports Second Quarter and First Six Months of 2020 Financial Results, Recent Corporate Achievements and Strong Cash Position (GlobeNewswire) - "Significant Progress Achieved in Development of a Plasma-Derived Immunoglobulin (IgG) Product as a Potential Treatment for Coronavirus Disease (COVID-19)....'Earlier this week we announced first-patient-in our Phase 1/2 open label clinical trial in Israel. We are also working with the support of our partner, Kedrion Biopharma, toward obtaining FDA’s acceptance of the proposed clinical development program and we expect to hold a pre-IND meeting with the FDA during this quarter.'"

FDA event • Trial status • Infectious Disease • Novel Coronavirus Disease

Kedrion Biopharma forms research partnership with Columbia University Irving Medical Center to support development of new IgG therapy for COVID-19 (PRNewswire) - "Kedrion Biopharma...has formed a research partnership with Columbia University Irving Medical Center to develop and test a new IgG therapy for COVID-19 which is being developed by Kedrion and Kamada Ltd....Kedrion will supply Columbia with convalescent plasma from patients who have recovered from COVID-19 to be used for the manufacturing of IgG therapy....Evaluation of the neutralizing assay of the hyperimmune Immunoglobins should be completed by early August, and human clinical trials may be initiated pending authorization from the U.S. Food and Drug Administration."

Licensing / partnership • New trial • Infectious Disease • Novel Coronavirus Disease

Kamada Announces Availability of its Plasma-Derived Hyperimmune IgG Therapy for Coronavirus Disease (COVID-19) for Compassionate Use Treatment in Israel (GlobeNewswire) - "Kamada completed manufacturing of the first batch of its plasma-derived IgG product for COVID-19....initial vials are available for compassionate use in Israel....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....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)..."

Commercial • FDA event • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease

Kamada reports first quarter 2020 financial results and highlights recent corporate progress (BioSpace) - "Recent Corporate Highlights: Announced a collaboration with Kedrion Biopharma for the development, manufacturing and distribution of a plasma-derived hyperimmune IgG product for COVID-19; Initiated manufacturing of the product based on collected convalescent plasma in Israel; product is expected to be available for clinical and compassionate use treatment in Israel by the end of the second quarter."

Launch non-US • Licensing / partnership • Infectious Disease • Novel Coronavirus Disease