Biota tanks as its flu drug comes up empty in Phase II

Biota Pharmaceuticals' ($BOTA) slow trip downward continued Friday as the company disclosed that its lead program, a flu treatment called laninamivir octanoate, failed to beat out placebo in a midstage study, sending its shares to an all-time nadir.

In a Phase II trial involving 638 patients, neither the 40-mg or 80-mg doses of laninamivir were able to significantly beat placebo on the study's main endpoint, a reduction in the time it takes flu symptoms to clear up. The drug, a neuraminidase inhibitor, came through on some secondary goals, the company said, and charted a safety profile similar to placebo.

The flop is the latest setback in a challenging year for Biota. In the fall, the company walked away from its preclinical antibiotics work to better focus on the promise of laninamivir, then under development with the help of a $231 million contract with the federal Biomedical Advanced Research and Development Authority (BARDA). In April, however, BARDA pulled the plug on that deal, leaving Biota stranded and forcing the Australian company to lay off two-thirds of its staff.

Thanks to a 2003 deal with Daiichi Sankyo, laninamivir is already on the market in Japan as Inavir. Biota holds rest-of-the-world rights to the drug, but, in light of the Phase II failure, the company is rethinking its global strategy, CEO Russell Plumb said.

"We expect to complete a full analysis of additional clinical, safety, and pharmacokinetic data forthcoming from this trial over the next several months," Plumb said in a statement. "However, at this time we do not have any plans to independently advance the development of LANI for the treatment of influenza and intend to evaluate next steps for the LANI program outside of Japan with our partner, Daiichi Sankyo."

Laninamivir's Phase II failure sent Biota's shares down as much as 29% on Friday morning, and the company's value has dropped by nearly 50% since losing the BARDA deal.

- read the statement

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