update - includes statement from Gilead

Gilead HIV drug API sourcing suit reopened by US Appeal Court

By Gareth Macdonald contact

- Last updated on GMT


Related tags: Appeal

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​.

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