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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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