The European Medicines Agency Has Approved Kamada's Plan for a Phase 1 Clinical Trial of Alpha 1-Proteinase Inhibitor (API) Respiratory Treatment for Congenital Emphysema
Kamada has applied to EMEA in February this year, and having been granted approval of its plan will work to speed up trial performance. Discussions between Kamada and EMEA have begun also on protocols of phase 2 and 3 of the clinical trials. Related information that will help Kamada register the drug in Europe was received.
Kamada CEO David Tsur stated that this product has been designated an Orphan Drug both in the U.S and in Europe for treating Congenital Emphysema and Cystic Fibrosis. This designation grants Kamada a range of support mechanisms such as research fund support, tax incentives, tolerance on fees and also a 7-year marketing exclusivity if the Company's inhaled API product will be the first on the market.
Kamada today is at an advanced R&D stage of its inhaled API (administered directly to the lungs via an inhalator). Kamada's API in its infusion form is used to treat Congenital Emphysema, caused by an in-born deficiency in Alpha-1 proteinase inhibitor. As far as the company knows, it is the only infused API drug product that does not require mixing or diluting prior to infusion, which gives Kamada an outstanding vantage point in the development of the respiratory form of the API.
Kamada, an Israeli bio-pharmaceutical company, develops, produces and markets life-saving pharmaceuticals administered by infusion in emergency and trauma situations, distributed in more than 15 countries worldwide. Kamada also provides third parties with R&D services for plasma derived products.
Kamada's flagship product -- the API for the treatment of Congenital Emphysema -- is currently undergoing advanced clinical testing with the FDA, and is already administered in a number of countries.
In 2005 Kamada successfully completed an initial public offering at the Tel Aviv Stock Exchange. The main shareholders are Ralph Hahn, David Tsur and GlenRock Group headed by Leon Recanati.