Kamada Ltd. (TASE: KMDA) today announced that it has obtained US Food and Drug Administration (FDA) approval for a shortened Phase III clinical trial of its KamRAB rabies vaccine. The shortened trial will slash development costs and time to register and market the product in the US.
The Phase III trial aims to test the safety of KamRAB and its effectiveness in boosting the level of rabies antibodies.
Kamada has been marketing KamRAB in Israel and several other countries worldwide since 2003, and the vaccine has reached $2 million in annual sales over the past several years.
Kamada CEO David Tsur said, "The rabies vaccine is another product that Kamada aims to market in the US, alongside the expected launch in 2010 of intravenous AAT for alpha 1 patients in the US."
AAT (Alpha-1 Antitrypsin) 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 rose 3.5% in morning trading to NIS 22.45, giving a market cap of NIS 550 million.
Published by Globes [online], Israel business news - www.globes-online.com - on January 20, 2010
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