UMN-0501 is a pandemic influenza vaccine manufactured in insect cells through the use of recombinant DNA technology. UMN-0501 represents the most advanced cell-based pandemic influenza vaccine in the world. A cell-based influenza vaccine offers key advantages over influenza vaccines manufactured using older production methods such as speed, safety and cost effectiveness. Phase I/II clinical trials have been successfully completed with both immunogenicity and safety confirmed. Results were presented in February of 2008 at the World Health Organization's 5th Meeting on Evaluation of Pandemic Influenza Prototype Vaccines in Clinical Trials. The next step in development will be a Phase II/III clinical trial to confirm UMN-0501's safety and efficacy as a pre-pandemic vaccine. UMN-0501 was granted orphan drug status in May of 2008. UMN's influenza program was licensed from Protein Sciences Corporation in the United States. Under this agreement, UMN Pharma secured exclusive development, manufacturing and sales rights in Japan to Protein Sciences proprietary influenza program and related technology.