update - includes statement from Gilead

Gilead HIV drug API sourcing suit reopened by US Appeal Court

By Gareth Macdonald contact

- Last updated on GMT

iStock/robmen
iStock/robmen

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​.

Related news

Show more

Related products

show more

Integrated Solutions for Accelerated Time to Market

Integrated Solutions for Accelerated Time to Market

Piramal Pharma Solutions | 08-Jun-2021 | Technical / White Paper

Facing capacity constraints? Lock in your program now! With 14 sites around the world providing diverse services ranging from discovery to drug substance...

Transforming Clinical Development

Transforming Clinical Development

PerkinElmer | 01-Jun-2021 | Technical / White Paper

The estimated cost of bringing a drug to market in the U.S. according to JAMA is $1 billion.1 The extreme cost of clinical trials urge biopharmaceutical,...

Vaccine Innovation in the Era of COVID19

Vaccine Innovation in the Era of COVID19

Covance Patient Safety | 01-Oct-2020 | Sponsored Link

During this time of worldwide crisis, there is an increasing demand for the acceleration of a vaccination for COVID19. Regardless of the great recent advancements...

Lactium, your ally to manage day to day stress

Lactium, your ally to manage day to day stress

Ingredia | 27-Aug-2020 | Product Presentation

Stress has been called the ‘health epidemic of the 21st century’ by the World Health Organization. Increasingly, consumers are looking for safe, reliable...

Related suppliers

Follow us

Products

View more

Webinars