Kamada Ltd. (TASE: KMDA) has obtained Food and Drug Administration (FDA) approval to conduct a clinical trial in the US for the company's next generation drug - an inhalable version of AAT (Alpha-1 Antitrypsin deficiency) for the treatment of cystic fibrosis.
Kamada already markets an intravenous version of AAT, marketed as Glassia in US, and in other countries. The company will have to meet the FDA guidelines for a Phase II/III trial of inhalable AAT, which is already underway in Europe, in order to submit an Investigational New Drug (NDA) portfolio with the FDA. The current FDA approval is partly based on successful preclinical trials of the drug.
Kamada president and CEO David Tsur said, "We expect to shortly complete the necessary preparations for the clinical trial in order to obtain approval for the drug in the US market. The company has independent means and a plan to carry out trials of the drug in Europe and the US. We expect to complete the European Phase II/III clinical trial of inhalable AAT in 2013 and prepare for a Phase II trial in the US.
"The rapid growth of sales of intravenous AAT in the US and other countries, the company's state-of-the-art production platform, and its large number of products under development position Kamada at its best-ever starting line to achieve its clinical and business targets."
Kamada's share price rose 2% in early trading on the TASE today to NIS 20, giving a market cap of NIS 551 million.
Published by Globes [online], Israel business news - www.globes-online.com - on March 11, 2012
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