Several weeks after receiving US Food and Drug Administration (FDA) approval for intravenous AAT (Alpha-1 Antitrypsin) replacement therapy for congenital lung diseases, Kamada Ltd. (TASE: KMDA) today told investors that the inhalation version of the drug may also be used to treat cystic fibrosis and other diseases. Although the FDA has granted marketing approval for intravenous AAT, known as Glassia, it has not yet approved the inhalable version of the drug.
In the presentation, Kamada said that it expects to begin sales of intravenous AAT, Glassia, in the US during the current quarter. Clinical trials of inhalable AAT are scheduled to be completed in 2011-12, and the company expects to begin sales in 2013-14. Kamada has completed five successful clinical trials of inhalable AAT, including three Phase II trials. A Phase II/III clinical trial is underway in Europe.
Kamada disclosed for the first time that inhalable AAT, in addition to treating AAT gene deficiency, may be able to treat cystic fibrosis and bronchiectasis. The company has completed a Phase II clinical trial of the drug for cystic fibrosis. Expanding the number of diseases that inhalable AAT can treat increases sales potential, if and when it obtains regulatory approval.
Kamada said that it hoped to reach deal with strategic partners in the US and Europe in the second half of the year.
Kamada said in its presentation that rival Talecris Biotherapeutics Inc. (Nasdaq: TLCR) has "decided not to pursue studies evaluating inhaled plasma-derived Alpha-1 Antitrypsin. That decision leaves Kamada as the only company developing an inhalable AAT drug.
Kamada's share price rose 3.6% in morning trading to NIS 21.20, giving a market cap of NIS 561 million.
Published by Globes [online], Israel business news - www.globes-online.com - on July 21, 2010
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