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Biota/GSK lawsuit boosted by UK flu stockpiling

Biota Holdings' lawsuit against GlaxoSmithKline has been bolstered, the company claims, by the UK government's decision not to include Relenza in its GBP200 million flu vaccine stockpile plans.

On March 1, the UK government indicated its intention to purchase 14.6 million units of oseltamivir (Roche’s Tamiflu) over two years as part of the UK’s preparedness for an influenza pandemic. Biota believes the government’s decision overlooked Relenza due to lack of support from GSK.

“The UK stockpiling decision reinforces our claim against GSK for damages associated with their failure to support Relenza,” said Biota CEO, Peter Molloy. “Relenza is an effective drug that was first to market, but was shelved by Biota’s marketing partner despite their commitment to support the product.”

Both Relenza and its competitor, Tamiflu, are considered to be effective against avian flu strains and both have been recommended by health authorities for use in the management of pandemic influenza.

Biota is suing GSK for failing to adequately support Relenza after the
launch of the drug in 1999. In May 2004, Biota filed a lawsuit against GSK in the Supreme Court of Victoria in Australia, claiming that the company’s failure to support Relenza caused Biota substantial losses, especially in the face of the now growing flu antivirals market.

In January this year, the Court laid down a timetable for the suit, stipulating completion of full discovery by the end of June 2005 and mediation in November 2005. If the case is not settled by mediation, a trial could follow during 2006.

The UK stockpiling decision, although bad news for Relenza, could boost the prospects for Biota’s Sankyo co-developed second generation antiviral, LANI (longacting neuraminidase inhibitors). Recently, Biota received a $5.6 million grant from the US National Institutes of Health (NIH) to accelerate the development of LANI because of the drug’s perceived potential as a first line of defense against bird flu and other potential pandemic flu strains.