Gilead HIV drug API sourcing suit reopened by US Appeal Court

Gilead Sciences Inc. faces renewed allegations it bought an API used in three of its HIV drugs from an unapproved Chinese supplier after a US Court of Appeals ruling.

The allegation - that for a 16-month period starting in 2007 Gilead imported emtricitabine made by Synthetics China Ltd. into the US claiming the API came from an approved supplier - was detailed in a suit brought by ex-employees Jeff and Sherilyn Campie in 2014

The original lawsuit, and an amended version filed in June 2015, were both dismissed. However, in a ruling released yesterday the US Court of Appeals for the Ninth Circuit overturned the decision, reopening the case.

Gilead said in an emailed statement that: "We are disappointed with today’s ruling and intend to challenge this outcome and vigorously defend against these allegations."

Emtricitabine is an active pharmaceutical ingredient (API) used in three of Gilead’s HIV drugs, specifically Emtriva, Truvada, and Atripla

According to a US Securities and Exchange Commission (SEC) filing German chemical company Evonik has supplied Gilead with emtricitabine since 2006.