Full Press Release Details
Kamada Announces Availability of its
Plasma-Derived Hyperimmune IgG Therapy for
Coronavirus Disease (COVID-19) for Compassionate Use Treatment in Israel
REHOVOT, Israel - June 17, 2020
-- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a plasma-derived biopharmaceutical company, today provided an update on its development
of a plasma-derived immunoglobulin (IgG) product for Coronavirus Disease (COVID-19).
Kamada completed manufacturing of the first
batch of its plasma-derived IgG product for COVID-19 utilizing
the Company's approved proprietary IgG platform technology, and additional production is ongoing. The initial vials
are available for compassionate use in Israel. In addition, Kamada's proposed clinical protocol for a Phase 1/2 clinical
trial was submitted to the Israeli Ministry of Health, and the Company expects to initiate the study during the third quarter of
In order to expand its clinical development
program to the U.S., Kamada, with the support of Kedrion Biopharma, intends to conduct a pre-Investigational New Drug (pre-IND)
meeting with the U.S. Food and Drug Administration (FDA) early in the third quarter in order to obtain FDA's acceptance of
the proposed clinical development program. Pursuant to the Company's global collaboration agreement with Kedrion for the
development, manufacturing and distribution of the plasma-derived IgG product for COVID-19,
Kedrion is currently collecting COVID-19 convalescent plasma from U.S. recovered patients that will be used by Kamada to
manufacture additional batches of the product. Kedrion is collecting the plasma, through its plasma business unit, KEDPLASMA, at
23 FDA-approved centers across the United States.
"We are extremely pleased with the
rapid and important progress achieved to date in advancing our plasma-derived IgG product for COVID-19," said Amir London,
Kamada's Chief Executive Officer. "To the best of our knowledge, Kamada is the first company globally to complete
manufacturing of a plasma-derived IgG product for the treatment of COVID-19. This achievement validates our advanced IgG development
and manufacturing capabilities and our ability to rapidly focus our efforts on providing potential solutions to emerging pandemic
situations. We anticipate the initiation of a Phase 1/2 clinical trial in Israel during the third quarter and are concurrently
expanding our development program to the U.S. with our partner, Kedrion. We believe that Kamada and Kedrion two leaders in plasma-derived
protein therapeutics, are uniquely positioned to make a positive impact in the treatment of COVID-19 patients."
Kamada Ltd. ("the Company")
is a commercial stage plasma-derived biopharmaceutical company focused on orphan indications, with an existing marketed product
portfolio and a late-stage product pipeline. The Company uses its proprietary platform technology and know-how for the extraction
and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a highly-purified, liquid form, as well
as other plasma-derived immune globulins. The Company's flagship product is GLASSIA , the first liquid, ready-to-use,
intravenous plasma-derived AAT product approved by the U.S. FDA. The Company markets GLASSIA in the U.S. through a strategic partnership
with Takeda Pharmaceuticals Company Limited and in other countries through local distributors. The Company's second leading
product is KAMRAB , a rabies immune globulin (Human) for post-exposure prophylaxis against rabies infection. KAMRAB is FDA
approved and is being marketed in the U.S. under the brand name KEDRAB through a strategic partnership with Kedrion S.p.A.
In addition to GLASSIA and KEDRAB, the Company has a product line of four other plasma-derived pharmaceutical products administered
by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India
and other countries in Latin America and Asia. The Company has late-stage products in development, including an inhaled formulation
of AAT for the treatment of AAT deficiency. In addition, the Company's intravenous AAT is in development for other indications,
such as GvHD and prevention of lung transplant rejection. The Company leverages its expertise and presence in the plasma-derived
protein therapeutics market by distributing more than 20 complementary products in Israel that are manufactured by third parties.
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
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) Kamada intending to initiate Phase 1/2 clinical trial in hospitalized COVID-19 patients in Israel
during the third quarter of 2020; 2) Kamada and Kedrion working together to hold a pre-IND meeting with the FDA early in the third
quarter of 2020; 3) that to the best of its knowledge, Kamada is the first company globally to complete manufacturing of a plasma-derived
IgG product for the treatment of COVID-19; and 4) the belief that Kamada and Kedrion are uniquely positioned to make a positive
impact in the treatment of COVID-19 patients. 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, including its effect and duration,
availability of sufficient raw materials required to continue manufacturing of the plasma-derived hyperimmune IgG product
for COVID-19, competition from other products for the treatment of COVID-19 patients; the effects of the COVID-19 pandemic
and related government mandates on the availability of adequate levels of work-force required to maintain manufacturing plans,
ability to obtain regulatory approval for clinical trials of the plasma-derived hyperimmune IgG product
for COVID-19, unexpected results of clinical studies and on-going compassionate-use treatments, ability to find doctors
and medical facilities to collaborate on compassionate-use treatments, 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. 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