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Kamada submits clinical program to the EMEA for
phases II-III with its leading product
Ness Ziona, Israel, February -- 20 , 2007 – Kamada (TASE: KMDA), a
bio-pharmaceutical developer and manufacturer of prescription drugs, announced
today that it has submitted plans to the European Agency for the Evaluation of
Medicinal Products (EMEA) for phase II-III clinical trial of its aerosolized
formulation of Alpha-1 Antitrypsin [AAT, also known as API - Alpha-1 Proteinase
Inhibitor]. The drug was developed by Kamada to treat inborn deficiency of
Alpha-1 proteinase inhibitor, which may lead to emphysema.
The clinical plan was submitted following supportive comments and information
received from the EMEA under the “Orphan Drug Designation” (ODD) of the
aerosolized product, which was granted to Kamada by both the FDA and the EMEA.
ODD provides significant advantages during the development process, including
professional assistance by the regulatory authorities, availability of grants to
support the clinical development and, upon marketing authorization, exclusive
distribution rights for periods of 7 years in the USA and 10 years in Europe.
Kamada is currently marketing the intravenous version of its AAT product in
several countries. David Tsur, Kamada’s CEO, explained that the key advantages
of Kamada’s AAT over other products are its higher level of purity and its
ready-to-use formulation, requiring no dilution or other preparation. Mr. Tsur
also stated: “Our inhaled AAT will provide a more comfortable form of treatment.
In addition, since the product is administered directly to the lungs, a lower
dose will be required to achieve similar therapeutic results to the current
intravenous treatment . As a result, the treatment will be affordable to many
more patients. ”
“To the best of our knowledge, this is the first time that a pivotal clinical
program has been submitted for this type of treatment to any regulatory
authority, indicating the advanced development stage of aerosolized AAT by
Kamada. Since Kamada begun developing the drug, an increasing body of evidence
has been accumulating which shows the potential of aerosolized AAT to be
effectively used in additional indications, such as Cystic Fibrosis, for which
Kamada has also an Orphan Drug Designation” Tsur added.
About Kamada
Kamada is a biopharmaceutical company engaged in the development,
production, and marketing of high quality, ready to use, plasma therapeutics. In
addition to AAT, Kamada’s product line includes specific immune globulins and
other plasma-derived products which are manufactured using sophisticated
chromatographic purification technology. Kamada is a public company (TASE: KMDA)
based at Kiryat Weizmann Science Park, Ness Ziona, Israel.
For additional information, please contact Sivan Shatil,
sivan@idancom.com or 972-9-9514666
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