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 - Kamada Pharmaceuticals

Tags

Top Highlights

• 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. • Following Recent FDA Approval of Technology Transfer Process, CYTOGAM® Manufactured by Kamada at its Facility Now Available for Commercial Sales in U.S. • New Clinical Data Highlighting Five-year Real-world Survival Benefits of High Risk CMV Mismatch Lung Transplant Patients Receiving CYTOGAM were Presented at IDWeek 2023 • Company Establishes Scientific Advisory Board Focused on U.S. Clinical Programs for CYTOGAM Rehovot, Israel, and Hoboken, NJ – October 16, 2023 — Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a commercial stage global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, today announced multiple recent achievements related to CYTOGAM® (Cytomegalovirus Immune Globulin Intravenous [Human]) (CMV-IGIV), which is indicated for the prophylaxis of cytomegalovirus (“CMV”) disease associated with transplantation of kidney, lung, liver, pancreas and heart, and is the sole U.S. Food and Drug Administration (“FDA”) approved immunoglobulin (IgG) product for this indication. See important safety information listed below. Kamada announced that CYTOGAM manufactured at the Company’s facility in Beit Kama, Israel, is now available for commercial sales in the U.S. This follows the recent FDA approval of the technology transfer process of CYTOGAM from its previous manufacturer, CSL Behring. The availability of Kamada-manufactured CYTOGAM in Canada is expected later this year. The results of an investigator-initiated five-year retrospective study, consisting of 325 lung-transplant patients, evaluating the real-world use of CYTOGAM in combination with anti-viral agents for the prevention of CMV disease in high-risk CMV mismatch lung transplant recipients (CMV seronegative patients receiving a lung from a seropositive donor), conducted by senior author Fernando Torres M.D., Clinical Chief, Division of Pulmonary and Critical Care at University of Texas Southwestern Medical Center were presented at IDWeek 2023, that took place on October 11-15, 2023, in Boston, MA. Dr. Torres concludes his poster presentation by indicating that the use of a proactive multimodality CMV prophylaxis consisting of antivirals and immune augmentation with CMV immunoglobulin may improve outcomes among high-risk CMV mismatch lung transplant recipients. “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.