Hemispherx signs licensing agreement with Japan’s Biken

Under terms of the non-exclusive licensing arrangement, Hemispherx will receive both royalties as well as income for all Ampligen supplies used in both the ongoing experimental work and any subsequent marketing of Ampligen as an immunoenhancer for flu vaccines delivered intranasally in Japan. Additional rights accruing to Hemispherx from the three party agreements including National Institute of Infectious Diseases (NIID) allow exclusive conveyance of all intellectual property rights on Ampligen as an immunoenhancer.

The agreement with Biken (the non-profit operational arm of the Foundation for Microbial Diseases of Osaka University) is part of a three party agreement to develop an effective influenza vaccine for Japan and utilizes vast resources of the NIID of Japan.

To date, only two or three pharma companies worldwide are reported to have achieved regulatory authorizations to sell intranasally (IN) administered influenza vaccines versus many companies receiving approval for intramuscular vaccine delivery routes. In animal work to date conducted by NIID, Ampligen IN co-administration with vaccine caused the robust elaboration of Ig A (immuno globulin), a unique protective substance.

William Carter, CEO and chairman of Hemispherx, said: “We have observed that resistance to standard antivirals has increased from 1% in 1994 to 91% in 2005, underlining the importance of strengthening and enhancing cross-protection against viruses that already kill thousands each year, and threaten to breakout into a global pandemic.”