Tuesday, April 8, 2008

Kamada was Granted New Orphan Drug Designation by the FDA, for its Aerosolized AAT for the Treatment of Bronchiectasis

Apr 8, 2008 - Kamada (TASE: KMDA), a biopharmaceutical company which develops, manufactures and markets specialty life-saving therapeutics, announces today that the company was granted an Orphan Drug Designation to its Aerosolized Alpha-1 Antitrypsin (AAT) product to treat Bronchiectasis.

Kamada's aerosolized AAT product for treating Bronchiectasis, a lung disease that results in the distortion of one or more of the conducting bronchi or airways, is currently undergoing Phase II clinical trials.

According to David Tsur, CEO Kamada, "This significant recognition grants Kamada various benefits such as research fund support, tax incentives, reduced user fees and seven years of exclusive distribution rights, if the company's product is first on the US market for this indication."

According to Pnina strauss, Kamada's Clinical Trials and IP Director, "We believe that, pending the successful completion of the trials and registration process, the product will potentially both improve the quality of life and extend the life expectancy of Bronchiectasis patients. There is significant potential for the aerosolized version of AAT, which is an innovative form of treatment that addresses chronic inflammatory processes and prevents further degeneration of lung tissue and function."

According to Dr. Charles L. Daley, Chair of the Steering Committee for the COPD foundation's newly formed Bronchiectasis Registry and research consortium, "We see great potential in Kamada's aerosolized AAT product for treating the Bronchiectasis patient population, estimated at 100,000 in the US alone."

No comments: