UPDATE: European Agency Recommends Recall Of Gilead's Vistide

The European Medicines Agency, or EMA, on Tuesday recommended a precautionary recall of one batch of Gilead Sciences Inc.'s (GILD) Vistide antiviral drug due to potential contamination risks.

The Vistide batch in question was made at Ben Venue Laboratories, a contract drug manufacturer that suspended production at its Bedford, Ohio, plant in November to address various manufacturing deficiencies.

Ben Venue's deficiencies have had a ripple effect, leading to recalls of other drugs as well as an ongoing shortage of Johnson & Johnson's (JNJ) cancer drug Doxil. Ben Venue, a unit of Boehringer Ingelheim GmbH, makes sterile, injectable drugs on behalf of multiple companies.

Gilead has started to communicate with affected customers to implement the recall of Vistide, said spokeswoman Erin Rau. Since February, Gilead's Vistide supplies have come from "other batches and manufacturing routes, which are not subject to this recall," she said. The recall shouldn't affect overall availability of the product.

Vistide is approved to treat cytomegalovirus infections of the retina.

The EMA on Tuesday said an advisory body initially concluded in November that supplies of Vistide made at Ben Venue could continue to be used because the drug is sterilized at the end of the manufacturing process.

However, the EMA said it has now discovered possible contamination with particles, and the sterilization process couldn't guarantee the absence of particles in vials of Vistide.

The EMA said the recall won't cause a Vistide shortage because an alternative manufacturer is now supplying the European market.

-By Peter Loftus, Dow Jones Newswires; +1-215-982-5581; peter.loftus@dowjones.com

Gilead Sciences (NASDAQ:GILD)
Historical Stock Chart
From Jun 2024 to Jul 2024