This agreement guarantees Kamada a steady supply of raw material that meets the international standards set by the FDA and European Medicines Agency. The suppliers are also required to meet the highest standards of production and manufacturing control.
Intravenous alpha-1-antitrypsin (AAT) is used to treat alpha-1 deficiency, a hereditary disease, which can lead to emphysema. Kamada’s product has successfully completed Phase III clinical trials in the US.
David Tsur, CEO of Kamada, said: “This agreement will further secure Kamada’s control over the entire production cycle for AAT. A continuous supply of raw material will allow Kamada to move forward with its biologics license application filing for intravenous AAT in the US in 2009, its ongoing strategic marketing discussions and its future plans to bring its next generation, inhaled AAT, to patients with severe respiratory diseases such as alpha-1 deficiency, cystic fibrosis and bronchiectasis.”