Jun 05, 2009 - Kamada, a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its lead clinical candidate, intravenous alpha-1 antitrypsin (AAT-IV), for the treatment of Alpha-1 Antitrypsin Deficiency.

David Tsur, Chief Executive Officer of Kamada, said, "The submission of our AAT-IV BLA is an important milestone for Kamada, as it positions us one step closer to bringing our product to the US and European markets. We believe that the data supporting the BLA for our innovative AAT-IV are strong and we look forward to working with the FDA to bring this important and advantageous therapy to market for the benefit of the patient population."

According to company officials, Kamada has developed a high purity, liquid, ready-to-use human plasma derived AAT indicated for the treatment of Alpha 1 Deficiency. The product is produced using a chromatographic purification method.

From TradingMarkets.com