TOKYO, Aug. 29 (UPI) -- U.S. firm Protein Sciences Corp has signed a deal with Japanese company UMN Pharma to distribute PSC's flu vaccine FluBIOk, in Japan.
UMN has given PSC, based in Meriden, Conn., a multimillion dollar, up-front payment and will buy commercial quantities of FluBIOk from PSC until they can set up a manufacturing facility in Japan, PSC said.
When the vaccine is ready for distribution, UMN will pay PSC double-digit royalties.
"This recombinant influenza vaccine will provide Japanese people with a new option for the prevention of influenza. UMN believes that PSC's excellent clinical data reflect a significant breakthrough in the development of both annual and pandemic influenza vaccines with great promise for the health of the Japanese people," said Yasunari Kashihara, UMN's president and CEO.
FluBIOk was produced using recombinant DNA technology. A recently completed phase 2/3 trial showed the vaccine achieved 100 percent protection against both circulating and drifted strains of influenza and a more than 54 percent reduction in influenza-like illness, as defined by the U.S. Centers for Disease Control (CDC).
FluBIOk also produced protective antibody levels in humans against a potentially pandemic avian influenza virus and provided 100 percent protection to animals challenged with a lethal avian flu strain, PSC said. The vaccine has received "accelerated approval" status from the Food and Drug Administration, with PSC set to file a Biologics License Application for FluBIOk with the agency in early 2007.