Kamada Ltd. (TASE: KMDA) today announced that it has begun a Phase II/III clinical trial of its inhalable AAT drug in Europe for the treatment of Alpha-1 Antitrypsin (AAT) protein deficiency.
Kamada said that the trial to test aerosolized AAT's safety and effectiveness would be conducted at several European medical centers. This is the first trial of inhalable AAT in the world. If the trial is successful, and the expedited registration process is completed, the company hopes to obtain marketing approval for the drug in Europe and subsequently in the US. Aerosolized AAT has orphan drug status, which expedites the testing and registration process. If Kamada's drug becomes the first to reach market, it will have marketing exclusivity in Europe for ten years and in the US for seven years following approval by the European Medicines Agency (EMEA) and US Food and Drug Administration (FDA), respectively.
Kamada CEO David Tsur said, "We're proud with this achievement, and we're ready for this trial, which is an important stage in the drug development process." He predicts that aerosolized AAT will have greater revenue than intravenous AAT. Assuming that the clinical trial is a success and aerosolized AAT obtains marketing approval, marketing will begin in 2012.
In addition to treating of Alpha-1 Antitrypsin Deficiency, aerosolized AAT is undergoing trials for cystic fibrosis and bronchiectasis.
Intravenous AAT successfully completed a Phase III clinical trial for the treatment of Alpha-1 Antitrypsin Deficiency in the US. The FDA is due to visit Kamada's laboratory and production facilities in a few weeks to certify the drug. Kamada expects to begin marketing of intravenous AAT in the US later this year.
Kamada's share rose 1.2% by midday to NIS 25.21, giving a market cap of NIS 635 million.
Published by Globes [online], Israel business news - www.globes-online.com - on January 26, 2010
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