KAMADA SUBMITS TRIAL PLANS TO EMEA

Kamada has submitted plans to the European Medicines Agency (EMEA) for its Phase II/III trial of an aerosolized formulation of Alpha-1 Antitrypsin (AAT). The drug was developed by Kamada to treat inborn deficiency of Alpha-1 proteinase inhibitor, which may lead to emphysema.

The clinical plan was submitted following supportive comments and information received from the EMEA when it granted orphan drug designation to the aerosolized product. The designation provides significant advantages during the development process, including professional assistance by regulatory authorities, availability of grants to support clinical development and, upon marketing authorization, exclusive distribution rights for seven years in the U.S. and 10 years in Europe.

Kamada is currently marketing the intravenous version of the product in several countries. "Our inhaled AAT will provide a more comfortable form of treatment. In addition, since the product is administered directly to the lungs, a lower dose will be required to achieve similar therapeutic results to the current intravenous treatment. As a result, the treatment will be affordable to many more patients," David Tsur, Kamada's CEO, said.