Kamada Announces Recent Achievements with CYTOGAM including Availability of Product Manufactured by the Company for U.S Commercial Sale and Presentation of New Clinical Data - Seite 2

“The prevention of CMV disease is an area of significant unmet medical need and a leading cause for organ rejection and severe transplantation complications,” said Amir London, Kamada’s Chief Executive Officer. “The results presented by Dr. Torres align with previously published data regarding the survival benefit of high-risk CMV mismatched lung transplant patients receiving a prophylaxis regimen that includes CYTOGAM and an antiviral vs. antiviral monotherapy. In addition, the significant milestone of launching our internal commercial manufacturing of CYTOGAM further validates our investment in this critical life-saving product, and our commitment to serving the transplant community.”

The Company recently established its first Scientific Advisory Board consisting of eight U.S. based world-renowned thought leaders in the solid organ transplantation field. The advisory board focuses on Kamada’s newly implemented U.S. clinical program for CYTOGAM including new opportunities and future research and development possibilities.

About CYTOGAM
CYTOGAM (Cytomegalovirus Immune Globulin Intravenous [Human]) (CMV-IGIV) is indicated for the prophylaxis of cytomegalovirus disease associated with the transplantation of the kidney, lung, liver, pancreas and heart. The product is the sole FDA-approved immunoglobulin (IgG) product for this indication.

Important Safety Information
CYTOGAM is contraindicated in individuals with a history of a prior severe reaction associated with the administration of this or other human immunoglobulin preparations. Persons with selective immunoglobulin A deficiency have the potential for developing antibodies to immunoglobulin A and could have anaphylactic reactions to subsequent administration of blood products that contain immunoglobulin A, including CYTOGAM.

Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. Patients predisposed to acute renal failure include patients with any degree of preexisting renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentrations available and the minimum rate of infusion practicable. Agents containing sucrose as a stabilizer (CYTOGAM contains sucrose) have been associated with reports of renal dysfunction given at daily doses of 350 mg/kg or greater.