BioDiem gets a sniff of $50 million 'flu vaccine fund

In the middle of its AUD$10 million float, Melbourne pharmaceutical development company BioDiem has been buoyed by news that the US Food and Drug Administration has allocated $US50 million to boost production of influenza vaccines, which are in chronically short supply in North America.

An unusually virulent strain of the 'flu virus has swept across 24 US states, in an epidemic that has exhausted vaccine supplies.

BioDiem's portfolio of four products that have already passed proof-of-concept stage includes FluVacc, a purpose-built vaccine strain of influenza virus developed by Prof Larisa Rudenko's research team at the Institute of Experimental Medicine in St Petersburg in Russia.

BioDiem has acquired commercial rights to produce the vaccine, and has also obtained a license from international pharmaceutical company Merck for a new method of producing vaccines in mammalian cells.

The North American vaccine shortage is due in part to the archaic method still used to produce influenza vaccines, which involves inoculating fertilised chicken eggs with live, attenuated strains of emergent, epidemic strains of the 'flu virus.

The process is laborious, time-consuming, inefficient, and requires enormous numbers of eggs -- and the severe epidemic has also left the US struggling to produce enough eggs.

BioDiem's FluVacc is a live-attenuated virus strain that can be 'programmed' with the latest editions of genes for the haemagglutinin and neuraminidase proteins of emerging epidemic strains.

Russian researchers made the live-virus vaccine much safer by selecting for low-temperature tolerance. The FluVacc strain replicates optimally at temperatures in the mid-20s, and is rapidly inactivated by the 38-degree warmth of the human body when it is administered intranasally.

US Health and Human Services Secretary Tommy Thompson said this week that Congress was so concerned at the limitations of current 'flu vaccine production methods that it will spend $US50 million to buy enough eggs to produce enough vaccine to deal with the current epidemic, and to develop new production methods that don't rely on eggs.

In addition to being in short supply, some individuals can suffer an allergic reaction to residual egg antigens in vaccines.

BioDiem CEO Tom Williams said that, with Merck's mammalian-cell culture system, 20 million doses at a time can be produced in a 2000-litre stainless steel nutrient tank -- the technique is much faster and cheaper, and not a single egg is required.

Live, inhaled 'flu vaccines are favoured over inactivated strains produced in eggs because they confer broader immunity, according to Dr Anold Monto, professor of epidemiology at the University of Michigan School of Public Health.

BioDiem is currently running a Phase I (safety and immunogenicity) clinical trial of a mammalian-cell grown, updated versin of FluVacc in 300 volunteers. It expects to report the results in the second quarter of next year.