Kamada applies for FDA approval for clinical trial

The company commenced clinical trials of the intravenous version of the drug in February.

Biopharmaceutical company Kamada Ltd. (TASE: KMDA) has filed for US Food and Drug Administration (FDA) approval to commence Phase II clinical trials of the aerosolized form of its Alpha-1 Antitrypsin (AAT) product to treat Cystic Fibrosis (CF). The company applied for approval from the European Medicines Agency last month. Earlier this year Kamada commenced Phase III trials of the intravenous version of AAT.

Kamada CEO David Tsur said, "There is significant potential for the inhaled version of AAT, in view of the number of CF suffers and carriers, estimated by the US-based Alpha 1 Association to total 200,000 worldwide. According to an external survey, just 5,000 of these are currently receiving treatment. The cost of administering a drug by inhalation will be lower than that of intravenously administered drugs. In addition, parallel to the use of the drug in the treatment of CF, there is now increasing evidence of the drug's efficacy in treating other respiratory diseases and as a consequence, we are now working on the development drug for other indications, in cooperation with leading doctors in the field."

Kamada’s inhaled AAT has been designated an orphan drug for the treatment of CF, in both Europe and the US.

Published by Globes [online], Israel business news - www.globes.co.il - on October 21, 2007

© Copyright of Globes Publisher Itonut (1983) Ltd. 2007

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