Full Press Release Details
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
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.
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
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.
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
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.
Kamada Ltd. (the "Company") is 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, focused on diseases of limited treatment alternatives. The Company is also advancing an innovative
development pipeline targeting areas of significant unmet medical need. The Company's strategy is focused on driving profitable
growth from its significant commercial catalysts as well as its manufacturing and development expertise in the plasma-derived and biopharmaceutical
fields. The Company's commercial products portfolio includes six FDA approved plasma-derived biopharmaceutical products: CYTOGAM ,
KEDRAB , WINRHO SDF , VARIZIG , HEPAGAM B and GLASSIA , as well as KAMRAB , KAMRHO (D) and two types of
equine-based anti-snake venom (ASV) products. The Company distributes its commercial products portfolio directly, and through strategic
partners or third-party distributors in more than 30 countries, including the U.S., Canada, Israel, Russia, Argentina, Brazil, India,
Australia and other countries in Latin America, Europe, Middle East, and Asia. The Company leverages its expertise and presence in the
Israeli market to distribute, for use in Israel, more than 25 pharmaceutical products that are supplied by international manufacturers
and during recent years added eleven biosimilar products to its Israeli distribution portfolio, which, subject to the European Medicines
Agency (EMA) and the Israeli Ministry of Health approvals, are expected to be launched in Israel through 2028. The Company owns an FDA
registered plasma collection center in Beaumont, Texas, which currently specializes in the collection of hyper-immune plasma used in the
manufacture of KAMRHO (D). In addition to the Company's commercial operation, it invests in research and development of new product
candidates. The Company's leading investigational product is an inhaled AAT for the treatment of AAT deficiency, for which it is
continuing to progress the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. FIMI Opportunity
Fund, the leading private equity investor in Israel, is the Company's lead shareholder, beneficially owning approximately 38% of
the outstanding ordinary shares.
Cautionary Note Regarding Forward-Looking Statements
This release 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 statements
regarding: (1) the availability of Kamada-manufactured CYTOGAM in Canada is expected later this year; (2) recent scientific publication
suggest that 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, (3) Kamada commitment to serving the transplant community;
and (4) the Company's belief of new opportunities and future research and development possibilities for CYTOGAM. 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 conflicts on market
conditions and the general economic, industry and political conditions in Israel, the U.S. and globally, availability of sufficient raw
materials required to maintain manufacturing plans, meeting the Canadian health authorities requirements for the commercial launch of
CYTOGAM manufactured by the Company in Israel, continued utilization of Kamada's Israeli manufacturing site, continuation of inbound
and outbound international delivery routes, continued demand for the IgG product portfolio, financial conditions of the Company's
customers, suppliers and services providers, Kamada's ability to leverage and expand its international distribution network, Kamada's
ability to manage operating expenses, additional competition in the markets that Kamada competes, regulatory impact and potential delays