By Meg Flippin Benzinga
DETROIT, MICHIGAN - June 6, 2025 (NEWMEDIAWIRE) - Cytomegalovirus (CMV) is a common virus that most adults are exposed to at some point in their lives, and over half of American adults have been infected by age 40. A healthy immune system can keep the virus at bay, and it’s usually harmless. But for organ transplant recipients, contracting CMV disease can be dangerous and even deadly in some cases. About 20% to 60% of people who have a solid organ transplant develop a symptomatic CMV infection. It's one of the most common complications for solid organ transplant recipients. While effective strategies that often use antiviral medicines to prevent or treat CMV exist, none offer a completely foolproof solution, nor is there any vaccine available to prevent it in advance.
Kamada Ltd. (NASDAQ: KMDA), a global biopharmaceutical company and provider of specialty plasma therapeutics, is advancing efforts to support organ transplant patients and their doctors in managing CMV with CYTOGAM®, the company’s cytomegalovirus immune globulin, Kamada is initiating a post-marketing research program to further drive awareness about its potential.
CYTOGAM, indicated for the prevention of CMV disease associated with the transplantation of the kidney, lung, liver, pancreas and heart, is an intravenous immunoglobulin composed of antibodies to CMV derived from human plasma. It functions as an antiviral agent by acting outside the host cell, complementing the action of a standard antiviral that works inside the host cell. According to the company, that combination is beneficial in fighting the condition, especially in patients who are at high risk of developing CMV disease after their transplantation. Please refer to the bottom of this publication for Selected Important Safety Information for CYTOGAM.
New Data On The Way To Support CYTOGAM’s Benefits
In 2021, Kamada acquired CYTOGAM from its previous owner, and in 2023 the company received approval from the U.S. Food and Drug Administration for the manufacturing of the product. For the year ended Dec. 31, 2024, Kamda reported revenue of $22.5 million from sales of CYTOGAM, a 31% increase over the prior fiscal year. To further drive adoption, the company announced the launch of a new post-marketing research program aimed at generating key data in support of the benefits of CYTOGAM.
Kamada said the new research program, which it developed in collaboration with Key Opinion Leaders (KOLs), is aimed at advancing CMV disease management through novel strategies focused on late-onset CMV prevention and mitigation of active CMV disease, exploring alternative dosing strategies and even investigating potential new applications of CYTOGAM.
The program also includes research aimed at enhancing the understanding of CYTOGAM’s mechanism of action and its functional properties against CMV and other viruses. Health economic studies to analyze the cost burden of CMV in solid organ transplantation are also planned, along with a clinical practice study to better understand the nuances of current CMV management in lung transplantation.
“CMV disease continues to be a significant risk factor for graft rejection and mortality in organ transplantation. However, for years, no material new up-to-date clinical data regarding the benefits of CYTOGAM were published,” said Amir London, Kamada’s CEO. “We believe that the data to be generated through our comprehensive program may demonstrate the various benefits of CYTOGAM in the prevention and management of CMV disease, supporting further product utilization over the coming years.”
Working With The Experts
Kamada is no stranger to working with KOLs to study CYTOGAM and then present their clinical data at conferences.
Back in 2023, Fernando Torres, M.D., clinical chief, Division of Pulmonary and Critical Care at University of Texas Southwestern Medical Center, presented the results of a five-year retrospective cohort study at ID Week, the premier conference for infectious diseases. The study of 325 lung transplant patients investigated CYTOGAM in combination with anti-viral agents to treat CMV in transplant patients. Dr. Torres concluded that the use of antiviral and CMV immunoglobulin may improve outcomes among high-risk CMV mismatch lung transplant recipients (Donor positive, Recipient negative), the company reports.
Then, in 2024, at the American Transplant Congress – the joint annual meeting of the American Society of Transplantation (AST) and the American Society of Transplant Surgeons (ASTS) – Jennifer Chow, M.D., transplant infectious diseases specialist at Tufts Medical Center, presented the results of a study analyzing the stored samples of a previously conducted placebo-controlled randomized controlled interventional study of CYTOGAM prophylaxis that demonstrates the potential antiviral and disease attenuation effect of CYTOGAM in moderate to low CMV risk liver transplant patients, reports Kamada.
Furthermore, in April this year, Kamada presented the results of internal research comparing the functional properties of CYTOGAM and regular immune globulin intravenous (IVIG) against CMV and other common viruses at the International Society for Heart & Lung Transplantation 2025 Annual Meeting. Kamada said the study demonstrates that CYTOGAM has fourfold higher anti-CMV antibodies than regular IVIGs.
CMV is a common virus, but it can be deadly for organ transplant recipients. Kamada is hoping to help patients and physicians to better manage it with CYTOGAM. With a new post-marketing research program underway, Kamada is focused on getting the word out about CYTOGAM’s benefits and on helping improve the quality of life of patients.
Featured image by Jonathan Borba on Unsplash
This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice.
This content was originally published on Benzinga. Read further disclosures here.
This post includes forward-looking statements within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, including (among others) statements regarding: 1) program’s ability to generate key data in support of the benefits of CYTOGAM in the management of CMV in solid organ transplantation, to advance CMV disease management, develop alternative dosing strategies and new applications of CYTOGAM, 2) successful FDA approval for additional uses of CYTOGAM, and 3) increased utilization of CYTOGAM as a result of positive results from the program or otherwise. Forward-looking statements are based on Kamada’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to the evolving nature of the conflicts in the Middle East and the impact of such conflicts in Israel, the Middle East and the rest of the world, the impact of these conflicts on market conditions and the general economic, industry and political conditions in Israel, the U.S. and globally, and particularly the effect on establishment and timing of the program, Kamada’s ability to leverage new business opportunities and integrate new product portfolio relating to CYTOGAM, unexpected results of the program, regulatory delays, and other risks detailed in Kamada’s filings with the U.S. Securities and Exchange Commission (the “SEC”) including those discussed in its most recent Annual Report on Form 20-F and in any subsequent reports on Form 6-K, each of which is on file or furnished with the SEC and available at the SEC’s website at www.sec.gov. The forward-looking statements made herein speak only as of the date of this announcement and Kamada undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.
Selected Important Safety Information for Cytogam® (Cytomegalovirus Immune Globulin Intravenous [Human])
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. During administration, the patient’s vital signs should be monitored continuously, and careful observation made for any symptoms throughout the infusion. Epinephrine and diphenhydramine should be available for the treatment of an acute anaphylactic reaction Increases in serum creatinine and blood urea nitrogen (BUN) have been observed as soon as one to two days following IGIV infusion. Progression to oliguria or anuria requiring dialysis has been observed. Immune Globulin Intravenous (Human) products can contain blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin reaction and, rarely, hemolysis. Cytogam® is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated. Minor reactions, such as flushing, chills, muscle cramps, back pain, fever, nausea, vomiting, arthralgia, and wheezing, were the most frequent adverse reactions observed during the clinical trials for Cytogam.
Please see full Prescribing Information for full prescribing details.
To report SUSPECTED ADVERSE REACTIONS, contact Kamada at pharmacovigilance@kamada.com or 1-(866)-916-0077 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
View the original release on www.newmediawire.com
