Full Press Release Details
Kamada Provides Update on Recent Progress Achieved
in Ongoing Pivotal Phase 3 Clinical Trial of Inhaled AAT
Rehovot, Israel, and Hoboken, NJ, November
7, 2022 - Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a vertically integrated global biopharmaceutical company focused on specialty
plasma-derived therapeutics, today provided an update on recent progress achieved in its ongoing pivotal Phase 3 InnovAATe clinical trial
evaluating the safety and efficacy of the Company's proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1
Antitrypsin Deficiency (AATD).
Earlier this year, following the moderation of
the COVID-19 pandemic, the study was expanded to additional sites across Europe and enrollment has recently begun to accelerate. To date,
30 patients have been enrolled for treatment, including 14 patients who have already completed the two-year study treatment period at
the initial trial site in Leiden, the Netherlands. Importantly, none of these patients discontinued treatment prematurely and no drug-related
serious adverse events were reported. Additionally, as part of routine and planned monitoring processes, and for the fourth time since
study initiation, the independent Data Safety Monitoring Board (DSMB) recently recommended that the trial continue without modification.
Moreover, based on the encouraging safety observed to date, the DSMB supported an expansion to the inclusion criteria to also include
subjects with severe airflow limitation (40%<FEV1<80% of predicted; previously inclusion criteria were 50%<FEV1<80%), which
is expected to further expedite patient enrolment.
"The strong association between AATD and
Chronic Obstructive Pulmonary Disease (COPD) or emphysema suggests that inhaled administration of AAT directly to the lungs may benefit
AATD patients," said Jan Stolk, M.D., Department of Pulmonology, Member of European Reference Network LUNG, Leiden University Medical
Center, The Netherlands. "Based on results published in the European Respiratory Journal in 2019, Kamada's previously completed
randomized placebo-controlled clinical trial suggested that a decline in lung function as measured by FEV1, the most important parameter
associated with shortness of breath, could be attenuated by daily AAT inhalation. Importantly, we have treated 19 patients to date at
our site in Kamada's pivotal Phase 3 InnovAATe clinical trial, none of whom dropped out, indicating high patient adherence to the treatment.
I am highly encouraged by the recent expansion of the trial to additional sites across Europe, and hope that the study results, once available,
will validate that daily AAT inhalation is an effective and safe treatment for AATD patients suffering from emphysema. If so, I look forward
to supporting regulatory approval of Kamada's inhaled AAT for the benefit of the AATD community."
the most advanced investigational product for AATD, a substantial commercial opportunity exists for Inhaled AAT to be a transformational
next-generation augmentation therapy in the AAT market, which is already over $1 billion in annual sales in the U.S. and EU," said
Amir London, Kamada's Chief Executive Officer. "We are pleased with the continued progress of the InnovAATe trial, the preliminary
safety profile demonstrated to date, and support from AATD patients and physicians, which is reflected in the adherence to the treatment.
We intend to meet with the FDA and EMA during the first half of 2023 to discuss trial progress and potential opportunities to shorten
the regulatory pathway."
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) the potential expansion of the study which may accelerate enrollment, 2) potential
successful results from the Phase 3 clinical study, 3) potential benefits of Inhaled AAT, including treatment for AATD patients
suffering from emphysema and inhaled administration of AAT directly to the lungs being beneficial to AATD patients, and 4) Inhaled AAT
being a transformational next-generation augmentation therapy in the AAT market. 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, unexpected results of the Phase 3 clinical study, delays with the studies, additional
competition in the AAT market, regulatory delays, changes with FDA and other regulatory agencies' rules and regulations,
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