Full Press Release Details
Kamada Announces Submission of Application to
the U.S. FDA to Manufacture CYTOGAM at the
Company's Facility in Israel
Rehovot, Israel, and Hoboken, NJ - January
4, 2023 - Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a vertically integrated global biopharmaceutical company, focused on specialty
plasma-derived therapeutics, today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) to manufacture
CYTOGAM (Cytomegalovirus Immune Globulin Intravenous [Human]) (CMV-IGIV) at its facility in
Beit Kama, Israel. The application was submitted as a prior approval supplement (PAS) and FDA approval is currently expected by
FDA approval will mark the successful conclusion of the technology transfer process for CYTOGAM from the previous manufacturer, CSL Behring.
A similar application to the Canadian health authorities is expected to be submitted imminently.
CYTOGAM technology transfer supplement includes an upstream protein solution manufacturing step performed by Prothya Biosolutions in its
plant in Belgium, under a contract manufacturing agreement between the parties.
CYTOGAM is indicated
for the prophylaxis of cytomegalovirus disease associated with the transplantation of the kidney, lung, liver, pancreas, and
heart, and is the sole FDA-approved immunoglobulin (IgG) product for this indication. CYTOGAM is the highest selling of the four IgG products
acquired from Saol Therapeutics in November 2021 and maintains gross margins of over 50%.
"The submission of this application to the
U.S. FDA to manufacture CYTOGAM represents an important operational milestone for our company," said Amir London, Kamada's
Chief Executive Officer. "Importantly, our business leveraged the significant benefits of
the acquired portfolio of four FDA-approved IgGs throughout 2022, and we expect additional growth from these important products in 2023
and beyond. We plan to initiate commercial manufacturing of CYTOGAM at our Israeli facility in the second half of this year upon receipt
of FDA approval, which will positively impact the facility's utilization and efficiency."
Kamada's currently available inventory of
CYTOGAM is sufficient to meet market demand until the currently anticipated FDA approval timing of mid-2023.
Kamada Ltd. (the "Company") is a vertically
integrated global biopharmaceutical company, focused on specialty plasma-derived therapeutics, with a diverse portfolio of marketed products,
a robust development pipeline and industry-leading manufacturing capabilities. The Company's strategy is focused on driving profitable
growth from our current commercial activities as well as our manufacturing and development expertise in the plasma-derived biopharmaceutical
market. The Company's commercial products portfolio includes its developed and FDA approved products GLASSIA and KEDRAB
as well as its recently acquired FDA approved plasma-derived hyperimmune products CYTOGAM , HEPAGAM B , VARIZIG and WINRHO SDF.
The Company has additional four plasma-derived products which are registered in markets outside the U.S. 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, Brazil, Argentina, India and other countries in Latin America and Asia. The Company has a diverse portfolio of
development pipeline products including an inhaled AAT for the treatment of AAT deficiency for which the Company is currently conducting
the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. The Company leverages its expertise
and presence in the Israeli pharmaceutical market to distribute in Israel more than 20 products that are manufactured by third parties
and have recently added eleven biosimilar products to its Israeli distribution portfolio, which, subject to EMA and the Israeli MOH approvals,
are expected to be launched in Israel through 2028. FIMI Opportunity Fund, the leading private equity investor in Israel, is the Company's
lead shareholder, beneficially owning approximately 21% 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) FDA approval for manufacturing of CYTOGAM in Israel anticipated in mid-2023, 2) similar application to be submitted to the
Canadian health authorities imminently, 3) additional growth expected for the IgG portfolio in 2023 and beyond, 4) commercial manufacturing
of CYTOGAM in Israel in the second half of 2023, and 5) current supply of CYTOGAM sufficient until the manaufacturing at the Israeli facilities.
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 continued evolvement
of the COVID-19 pandemic, its scope, effect and duration, availability of sufficient raw materials required to maintain manufacturing
plans, disruption to the supply chain due to COVID-19 pandemic, continuation of inbound and outbound international delivery routes, continued
demand for the IgG product portfolio, FDA and Canadian health authorities' approval process, financial conditions of the Company's
customer, suppliers and services providers, Kamada's ability to integrate the new product portfolio into its current product portfolio,
Kamada's ability to grow the revenues of its new product portfolio, and leverage and expand its international distribution network,
Kamada's ability to manage operating expenses, additional competition in the markets that Kamada competes, regulatory delays, prevailing
market conditions and the impact of general economic, industry or political conditions in the U.S., Israel or otherwise, 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.
Chief Financial Officer
LifeSci Advisors, LLC