Kamada Presents New Data on its Alpha-1 Antitrypsin at the American Thoracic Society Annual Meeting

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Tue May 19, 2009 9:00am EDT

NESS ZIONA, Israel--(Business Wire)--
Kamada, a bio-pharmaceutical company engaged in the development, manufacturing
and marketing of specialty life-saving therapeutics, today announced that new,
positive clinical data on its lead candidate, alpha-1 antitrypsin ("AAT"), has
been presented at the annual congress of the American Thoracic Society ("ATS"),
May 15 - 20, San Diego, California. 

"The results presented at ATS demonstrate the efficacy and safety of our
intravenous and inhaled versions of alpha-1 antitrypsin in respiratory disease,"
said David Tsur, Chief Executive Officer of Kamada. "Pending regulatory
processes, we hope to have our intravenous product in the US market during the
course of next year. We are also very excited about the prospects for our
inhaled version of alpha-1 antitrypsin in cystic fibrosis, and other respiratory
disorders, and look forward to continuing its development." 

Pivotal Phase II/III Study in AAT Deficiency

Robert Sandhaus, Professor of Medicine, Director Alpha-1 Program, National
Jewish Health, Denver Co.presented final data from Kamada's pivotal study, a
randomized, double blind, partial cross over study that explored Kamada`s
proprietary, liquid, ready to use, intravenous AAT ("Kamada-AAT") in patients
with AAT deficiency. Forty-nine patients were randomised 2:1 to receive 60mg/kg
Kamada-AAT or an equivalent intravenous comparator product, on a weekly basis,
for 12 weeks. After the first 12 week period all patients were dosed with
Kamada-AAT for a further 12 weeks. The study was designed to show
non-inferiority of Kamada-AAT to comparator AAT. The results of this study
support the primary endpoint. Adverse events considered related to the study
drug were similar to those reported for currently marketed AAT products. 

Phase II Proof-of-Concept Study in Cystic Fibrosis

Eitan Kerem, Professor of Pediatrics, Hadassah Medical Center, Mt. Scopus,
Jerusalem, presented final data from Kamada's Phase II, randomized, double
blind, study that examined efficacy and safety of an inhaled version of Kamada`s
AAT ("Inhaled-AAT") versus placebo. Twenty-one patients were randomized 2:1 to
receive 80mg Inhaled-AAT or placebo, once-daily, for 28 days. The data showed
efficacy, as measured by a reduction in sputum neutrophil elastase and
neutrophil count in patients treated with Inhaled-AAT. There were no serious
adverse events reported in this study and the only adverse event reported, that
was possibly related to study drug, was a sense of dry mouth (n=1). The results
from this proof-of-concept study show that AAT administered via the inhaled
route appears safe and biologically effective. Its impact on clinical endpoints,
including measures of lung function, will be the subject of future studies. 

Additional Analysis

Mark Brantly, Professor of Medicine, Molecular Genetics and Microbiology,
University of Florida School of Medicineand Alpha One Foundation Research
Professor, independently presented data at ATS in a poster entitled,
"Intravenous Augmentation with Kamada API Binds to Free Lung NE in Alpha-1
Antitrypsin Deficient Individuals with Lung Disease", which included an analysis
of bronchoalveolar lavage (BAL) data from sixteen patients in the pivotal trial.
Patients who received Kamada-AAT showed a >10 fold increase in AAT concentration
in the epithelial lining fluid ("ELF") after 12 weeks of augmentation therapy
and a significant increase in AAT-neutrophil elastase complexes. These data
confirm that Kamada-AAT reaches the lower respiratory tract and binds to free
neutrophil elastase in the ELF. 

About IV AAT

Kamada has developed a unique, high purity, liquid, ready-to-use human plasma
derived AAT indicated for the treatment of Alpha 1 Deficiency. The product is
produced using a sophisticated, chromatographic purification method. 

About Inhaled AAT

Kamada`s second generation AAT product to be administered via inhalation, is a
high purity Alpha-1 Antitrypsin preparation that utilizes an optimized
Investigational eFlow Nebulizer System (PARI Pharma GmbH). The product has been
designated as an Orphan Drug for the treatment of Alpha-1 Deficiency,
Bronchiectasis, and Cystic Fibrosis, in the U.S. as well as for Alpha-1
Deficiency and Cystic Fibrosis in Europe. This designation grants Kamada various
benefits such as research fund support, tax incentives, reduced official fees
and seven years of exclusive distribution rights, if the company`s product is
first on the market. 

About Kamada

Kamada is a public biopharmaceutical company (TASE:KMDA) developing, producing
and marketing a line of specialty life-saving biopharmaceuticals. Licensed and
marketed worldwide, several of these specialty therapeutics are currently
undergoing advanced clinical trials. Additional information is available at
www.kamada.com. 





Kamada
Pnina Straus, +972 8-940 6472
Clinical Development and IP manager
Pninas@kamada.com



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