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Kamada begins inhalable AAT trial
CEO David Tsur predicts that inhalable AAT will have greater revenue than intravenous AAT.
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.
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