SYDNEY, Australia ¿ Biota Holdings¿ share price gained much of its lost ground when it was revealed that the FDA agreed to allow an additional three months for reviewing its decision to reject the influenza drug Relenza.

Biota¿s share price jumped A$1.06 (US$0.66) in two days, to finish that week at A$5.95 after the FDA extension was disclosed by Biota¿s development partner, Glaxo Wellcome plc, of London.

Shares in the Melbourne-based company were almost A$9 in early February, when the FDA announced it would not approve Relenza, which uses technology developed by Biota and licensed to Glaxo, for sale . The share price fell to A$4, before briefly recovering to A$6, then sinking again.

Both Glaxo and Biota have repeatedly stated that the FDA rejection, based on concern about the lack of positive results in certain U.S. tests, is a temporary setback and Relenza will eventually be registered.

The FDA action involved extending the period for reviewing the application, following its rejection, past the normal cut-off date specified in FDA procedures. For Relenza, that cut-off date would have been April 27.

Glaxo has received approval for Relenza in Australia and Sweden, with Sweden expected to act as a reference member state in the European community¿s mutual-recognition process. Biota¿s chief financial officer, Richard Wadley, said that under the rules, once a drug is accepted in one country, getting registration in the others is easier. ¿ Mark Lawson