ASX Announcement
Date: 30 August 2006
BioDiem and Nobilon join top US science facility
in race to develop bird flu vaccine
Melbourne, August 30: In a major boost to the fight against the world bird flu pandemic threat, Melbourne based pharmaceutical development company BioDiem Ltd (ASX:BDM) today announced it had signed a cooperative research and development agreement (CRADA) with the US Centers for Disease Control and Prevention (CDC) to develop a cell culture candidate vaccine against avian influenza H5N1.
The agreement, co-signed with BioDiem’s international partner Akzo Nobel’s Nobilon, means BioDiem’s live attenuated intranasal flu vaccine will be advanced through pre-clinical development at the CDC in its high-security laboratories. According to experts at the World Health Organization, a live vaccine may offer better and broader protection in the event of a pandemic outbreak.
The CDC in Atlanta is the US government’s leading site for research into the prevention and monitoring of high-risk bio-terrorist and pandemic diseases.
The co-operative research will generate, characterize and evaluate, in pre-clinical models, live attenuated cold-adapted influenza vaccine (LAIV) candidates against influenza A H5N1 viruses.
BioDiem CEO Tom Williams said: “It’s a reflection of the potential of this live attenuated influenza technology that the CDC is contributing its resources to this program of work on BioDiem’s flu vaccine. We’re delighted that the scientists at CDC and our partner Nobilon will be working together with scientists from BioDiem on this vital project.”
“This is an extremely important collaborative agreement which could prove crucial in our efforts to develop a vaccine for one of the world’s leading health risks,” said Toon Wilderbeek, Akzo Nobel’s Board member, responsible for Pharma. “A key challenge for developers of potential pandemic vaccines is sufficient supply. One of Nobilon’s main areas of cutting-edge expertise is in cell culture production to provide benefits of scale-up, speed and efficiency. This is vital to any effective vaccination program.”
The US government has recently acknowledged that cell culture production of influenza vaccines may provide a superior service compared to the traditional supply based on embryonated eggs in that the production timeline may be shortened and vaccine production may be increased with fewer delays.
BioDiem has licensed the majority of the LAIV rights to Nobilon, which has recently received European GMP registration for its new facility in the Netherlands to begin manufacturing influenza vaccines in cell culture for clinical trials. BioDiem retains the right to license out the sales and marketing rights to the world’s largest market, North America. Japanese rights are to be shared with Nobilon.
Background
The breadth of response produced by BioDiem’s vaccine could be vital in dealing with a potential influenza pandemic.
The ability to efficiently transmit from human to human, which has not yet been seen, would indicate the H5N1 virus had changed, which may make current inactivated avian flu vaccines ineffective until they can be updated to include the new strain. A live attenuated pandemic vaccine may still provide some useful protection against a new but closely related strain until a more specific vaccine was made to match. A live attenuated influenza vaccine may also allow for a single dose of a smaller amount of vaccine to provide meaningful protection, compared with currently available inactivated vaccines which would mean more people could be vaccinated
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