Biota, an Australian company, which developed the Relenza flu med and licensed it to Glaxo in 1999, is accusing the big drugmaker of reneging on their deal by refusing to undertake proper marketing.

And in court papers being filed today in Australia, Biota is seeking up to $350 million in losses and damages. “Our assertion is that Glaxo made a decision not to market the product without telling us,” Biota ceo Peter Cook tells Pharmalot by telephone. “They should return it.”

In his view, Relenza got lost in the corporate shuffle that occurred when Glaxo purchased SmithKlineBeecham shoftly after the 1999 licensing deal. Relenza, he suggests, suddenly fell off the radar screen and, instead, Glaxo emphasized other products. At the time, Relenza had nearly 50 percent of the market, but its share soon dwindled to just 3 percent.

For the record, Relenza was known as a troubled med back then. The drug proved no better than placebo in a large clinical trial and wasn’t shown to be safe and effective in high-risk patients with pulmonary disease. An FDA panel didn’t recommend approval, but the agency endorsed it anyway. A year later, the FDA issued a warning after several deaths occurred.

But times change. Recently, Glaxo has been selling Relenza to ward off pandemic flu. Cook isn’t satisfied. He wants his drug back and thinks the troubles facing Tamiflu, which is causing anxiety in Japan over suicides among teens who’d taken the pill, is a missed opprotuntiy. “They’re still haven’t marketed it properly,” Cook sniffs.

Biota’s court documents and a press release;
Massachusetts General Hospital drug therapy committee review in 1999.[tags]Biota, GlaxoSmithKline, Relenza, Roche, Tamiflu[/tags]