Biotechnology drug developer Kamada Ltd. (TASE: KMDA) today announced that the US Food and Drug Administration (FDA) has awarded the commercial name "Glassia" for the company's intravenous AAT (Alpha-1 Antitrypsin) drug for congenital respiratory diseases. The approval is a necessary step for obtaining marketing approval of the drug in the US.
Kamada also set up a wholly-owned subsidiary in the US, Kamada Inc., in preparation for its market effort there. The offices will be based in Maryland, near the offices of the FDA and National Institutes of Health (NIH).
The FDA recently notified Kamada that it expected to complete its review of the company's biological license application (BLA) for intravenous AAT during the second quarter. The company therefore expects to receive marketing approval for the drug in early July.
Kamada has a distribution agreement for intravenous AAT with a major US distributor, whose name it has not disclosed. The distributor has undertaken a minimum of $15 million in sales of the drug within 18 months of the FDA approval.
AAT is a replacement therapy in individuals lacking this protein, for treating chronic obstruction pulmonary disease (COPD), which can refer to congenital emphysema, and bronchiectasis, or both. The company is also testing the treatment for cystic fibrosis.
Kamada's share price rose 2.3% in early trading today, bucking the market, to NIS 19.23, giving a market cap of NIS 515 million.
Published by Globes [online], Israel business news - www.globes-online.com - on May 9, 2010
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