Gilead Sciences disappointed investors yesterday with a hefty drop in its profits alongside an unexpected delay for its combo HIV drug program. Regulators turned back Gilead's application for a combo drug that includes both Truvada and the experimental TMC278 from Tibotec.
Wachovia analyst Brian Abrahams said that Gilead was likely looking at a four month delay as it hustled up additional information needed for the Chemistry, Manufacturing and Controls section of the app. The biotech company says that it expects to be able to refile in March. And Chief Scientific Officer Norbert Bischofberger wrote it off as a "minor delay."
TMC278 is an investigational non-nucleoside reverse transcriptase inhibitor.
"The letter stated that the application does not contain sufficient information on the analytical methodology to establish acceptable levels of recently identified degradants related to emtricitabine," says the company release. The hitch highlights just how important it is for Gilead to win new approvals and gin fresh revenue. "Ultimately our success over the long term is dependent upon innovation and pipeline advancement," said CEO John Martin.
- check out the Gilead release
- see the WSJ story