FDA awards exclusivity to Kamada drug

Kamada has developed a treatment for congenital emphysema. The company has obtained approval from the European Medicines Agency.

The US Food and Drug Administration (FDA) and European Medicines Agency (EMEA) recently granted "orphan drug status" for a drug developed by Israeli company Kamada Ltd. for the treatment of congenital emphysema.

Congenital emphysema is a pulmonary disease in which lung tissue is damaged by the lack of a protein called an API - Alpha 1 proteinase inhibitor. It is expected that it will take three years to complete development of the orphan drug.

Kamada's management believes that the new drug has a potential market of hundreds of millions of dollars. The current drug, delivered intravenously, costs $60,000-100,000 per patient per year. It is included in health baskets in the US and European countries.

Kamada has invested over $25 million to date in developing the drug. The money has come from independent resources, a strategic partner (a large pharmaceutical company that the company declines to name) and a grant from Israel-United States Binational Industrial Research and Development Foundation (BIRD-F).

This year, Kamada will begin deliveries of the current generation of the drug, delivered intravenously, development of which has been completed.

Kamada IP manager Pnina Strauss told "Globes" that the new drug could potentially treat other diseases, including cystic fibrosis. Kamada has obtained orphan drug status for its cystic fibrosis drug, but development is in the initial stages, and will only be launched in many years.

Kamada was founded in 1900 by president and CEO David Tsur and shareholder Ralph Hahn, who acquired KamadaPharm from Kibbutz Beit Kama. They founded Kamada under KamadaPharm. Tsur and Hahn own Kamada, which is based at Kibbutz Beit Kama, and has a development center at Kiryat Weizmann Science Park in Rehovot.

Kamada has 100 employees and scientists. It develops, manufactures, and markets over 15 drugs in Israel and around the world. Tsur told "Globes" that the company's turnover would be $10-15 million this year.

Published by Globes [online], Israel business news - www.globes.co.il - on January 5, 2005

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