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www.fdanews.com/articles/67216-us-fda-grants-exclusivity-to-kamada-emphysema-drug

US FDA GRANTS EXCLUSIVITY TO KAMADA EMPHYSEMA DRUG

January 6, 2005

Israeli drugmaker Kamada has reportedly received orphan-drug status from both the US FDA and European Medicines Agency, for a new congenital emphysema treatment. Development of the drug, which remedies a deficiency in lung tissue of a protein known as API-Alpha 1 proteinase inhibitor, is expected to last roughly three years.

Company sources claim that the potentially expensive treatment could earn proceeds of several hundred million US dollars. An existing version of the intravenously administered drug costs patients up to US$100,000 per year. The product has been funded by a US$25mn grant from the Israel-US Binational Industrial Research and Development Foundation, in partnership with an unidentified US drug major.