Gilead's adefovir to be filed for HBV in 2002

Gilead Sciences' first Phase III study of adefovir dipivoxil in patientswith chronic hepatitis B virus infection has met its primary endpoint, lifting the firm's share price 6.1% to $61.13 at the close on the day of the announcement (June 22). Gilead had previously dropped adefovir from development for the treatment of HIV when it failed to get approval from a US Food and Drug Administration advisory panel (Marketletter December 13, 1999).

Data from the pivotal trial (Study 437), evaluating the safety and efficacy of adefovir 10mg once-daily as monotherapy compared to placebo in 515 patients with chronic HBV infection, showed that Gilead's drug met the primary endpoint of an improvement in liver histology at week 48 compared to baseline, which was observed in 53% of patients treated with adefovir, compared to 25% of placebo-treated patients, as measured by liver biopsies (p<0.001). There was no additional benefit seen in a small arm of the study which investigated the effects of a 30mg dose of the drug. Gilead said it now expects to present a complete analysis of the trial at scientific conferences later this year and in 2002.

John Martin, Gilead's chief executive, noted that, "with positive data from this study and anticipated data from our second Phase III clinical trial, Study 438, later this year, we intend to submit regulatory filings for approval of adefovir 10mg in early 2002."