NESS ZIONA, Israel, May 24, 2017 (GLOBE NEWSWIRE) -- Kamada Ltd. (Nasdaq:KMDA) (TASE:KMDA.TA), a plasma-derived
protein therapeutics company focused on orphan indications, today announced that a poster comprising updated data from the
Company’s U.S. Phase 2 clinical trial of its proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1
Antitrypsin Deficiency (AATD) was presented by Professor Mark Brantly, M.D., Vice Chair of Research, Department of Medicine, Chief
Division of Pulmonary, Critical Care and Sleep Medicine, Professor of Medicine, Molecular Genetics and Microbiology at the
University of Florida College of Medicine and Alpha One Foundation Research Professor, at the 2017 American Thoracic Society (ATS)
International Conference, being held May 19-24 in Washington, D.C. AATD is an orphan disease currently treated by intravenous
AAT augmentation therapy.
The U.S. Phase 2 clinical trial was a double-blind, placebo-controlled study evaluating the safety and efficacy of AAT by
inhalation in 36 AATD patients. Patients were treated with Kamada’s AAT for inhalation (80 mg/day or 160 mg/day) or placebo via the
eFlow® device for 12 weeks during the double-blind period. Primary efficacy measures included antigenic AAT levels and
Anti-Neutrophil Elastase inhibitory (ANEC) levels in the lung, as well as additional anti-proteolytic and anti-inflammatory
biomarkers. Following this double-blind period, eligible patients (total of 26) entered an additional 12-week open-label extension
study with the active drug (160 mg/day) to further assess safety and tolerability. Previously announced top-line data from
this trial indicated that patients treated with Kamada’s inhaled AAT demonstrated a significant increase in endothelial lining
fluid (ELF), AAT antigenic and ANEC levels compared to the placebo group.
The updated data included in the poster presentation demonstrated that ELF-AAT, neutrophil elastase (NE)-AAT and ANEC complexes
concentration significantly increased in subjects receiving the 80 mg and 160 mg doses, (median increase of 38.7 neutrophil
migration (nM), p-value<0.0005 (80 mg/day, n=12), and median increase of 46.2 nM, p-value<0.002 (160 mg/day, n=10)).
This is a specific measure of the anti-proteolytic effect in the ELF and represents the amount of NE that was broken down by
AAT. The increase in levels of functional AAT was six times higher (160 mg per day) than is achievable with intravenous (IV)
AAT. In addition, ELF NE decreased significantly. Also, the 80 mg data demonstrated a significant reduction in the
percentage of neutrophils. Finally, aerosolized M-specific AAT was detected in the plasma of all subjects receiving inhaled
AAT, consistent with what was seen in the Phase 2/3 clinical trial of inhaled AAT conducted by Kamada in the EU.
“Inhaled AAT significantly increases functional AAT levels in the ELF versus placebo and versus what can be achieved with IV
AAT,” said Naveh Tov, M.D., Ph.D., Kamada’s Vice President, Clinical Development and Medical Director for Pulmonary Diseases.
“Inhaled AAT also restores protease anti-protease homeostasis and reduces the percentage of neutrophils and NE concentration in the
lower respiratory tract of AAT deficient individuals. Finally, detection of normal M-specific AAT in the plasma of study
subjects indicates that inhaled AAT passed from the alveolar compartment and the interstitial space. Collectively, we believe
that these findings, as well as the previously announced top-line data from this trial, and the clinically significant results of
our European Phase 2/3 study, support the use of inhaled AAT for the treatment of AATD.”
“The positive updated data from this clinical trial build on the previously obtained compelling top-line results,” said
Professor Brantly, the Primary Investigator of the clinical trial. “These most recent encouraging results further support the
use of inhaled AAT as a safe and effective treatment for AATD. I continue to be excited about the prospect of conducting a
pivotal clinical trial in the U.S. to further evaluate inhaled AAT in the clinic.”
“We are currently discussing a regulatory pathway in the U.S. for the Company’s inhaled AAT with the U.S. Food and Drug
Administration,” said Amir London, Kamada’s Chief Executive Officer. “We expect to have an approved Investigational New Drug
Application to conduct a pivotal Phase 3 study prior to the end of the year, which would allow us to initiate the clinical study in
the U.S. in 2018. In Europe, we anticipate a regulatory decision from the European Medicines Agency in regards to our inhaled
AAT for the treatment of AATD in the second half of 2017.”
The poster presented at the ATS meeting was titled, “A7677 - Inhaled Alpha-1-Antitrypsin (AAT) Restores Lower Respiratory
Tract Protease- Anti-Protease Homeostasis and Reduces Inflammation in Alpha-1 Antitrypsin Deficient Individuals: A Phase 2 Clinical
Study Using Inhaled Kamada-API”.
About eFlow® Technology and PARI Pharma
The Company’s inhaled AAT therapy is delivered by an investigational eFlow® Nebulizer System developed by PARI Pharma and optimized
specifically for Kamada. The optimized device uses eFlow Technology to enable highly efficient aerosolization of medication via a
vibrating, perforated membrane that includes thousands of laser-drilled holes. Compared with other nebulization technologies, eFlow
Technology produces aerosols with a very high density of active drug, a precisely defined droplet size and a high proportion of
respirable droplets delivered in the shortest possible period of time. Combined with its quiet mode of operation, small size, light
weight and battery use, eFlow Technology reduces the burden of taking daily, inhaled treatments.
About Kamada
Kamada Ltd. is focused on plasma-derived protein therapeutics for orphan indications, and has a commercial product portfolio and a
robust 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. AAT is a protein derived from human plasma with known and newly-discovered therapeutic roles
given its immunomodulatory, anti-inflammatory, tissue-protective and antimicrobial properties. The Company’s flagship product is
GLASSIA®, the first and only liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. Food and Drug
Administration. Kamada markets GLASSIA® in the U.S. through a strategic partnership with Baxalta (now part of Shire plc) and in
other counties through local distributors. In addition to GLASSIA®, Kamada has a product line of seven other 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. Kamada has five late-stage plasma-derived protein products in
development, including an inhaled formulation of AAT for the treatment of AAT deficiency for which a MAA was submitted to the EMA
after completing a pivotal Phase 2/3 clinical trials in Europe. Kamada has also completed its Phase 2 clinical trials in the
U.S for the treatment of AAT deficiency with inhaled AAT. In addition, Kamada's intravenous AAT is in development for other
indications such as type-1 diabetes, GvHD and prevention of lung transplant rejection. Kamada also leverages its expertise and
presence in the plasma-derived protein therapeutics market by distributing more than 10 complementary products in Israel that are
manufactured by third parties.
Cautionary Note Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as
amended, 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, such as
statements regarding assumptions and results related to financial results forecast, commercial results, timing and results of
clinical trials and EMA and U.S. FDA submissions and authorizations. 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, unexpected results of clinical trials, delays or denial in
the U.S. FDA or the EMA approval process, additional competition in the AATD market or further regulatory delays. 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.
CONTACTS: Gil Efron Deputy CEO & Chief Financial Officer IR@kamada.com Bob Yedid LifeSci Advisors, LLC 646-597-6989 Bob@LifeSciAdvisors.com
