Gilead says that counterfeit HIV drugs ended up in patients

The logo of the pharmaceutical company Gilead Sciences Inc was seen in Oceanside, California, USA, April 29, 2020. REUTERS / Mike Blake

NEW YORK, January 18 (Reuters) – Gilead Sciences Inc (GILD.O) said an unauthorized network of drug distributors and suppliers sold pharmacies for more than $ 250 million of counterfeit versions of their HIV treatments over the past two years years, and put patients at risk.

The drug manufacturer said it found 85,247 bottles that had been tampered with or counterfeited, including versions of the Biktarvy and Descovy treatments.

In a separate statement on Wednesday, Gilead said they had seized bottles of Gilead-labeled medicine from 17 locations in nine states as part of the investigation.

The investigation also revealed unauthorized pharmaceutical distributors who sold the drugs to pharmacies, Gilead said.

Gilead said on Tuesday that counterfeiters used authentic, but often empty or almost empty, bottles that once contained HIV medicine.

It said the counterfeiters then replaced counterfeit tablets and documentation, and re-sealed the bottles to “look” like unopened, authentic bottles.

The alleged scheme was previously reported by The Wall Street Journal.

Gilead revealed his efforts against counterfeiting the same day a federal judge in Brooklyn uncovered a related civil lawsuit filed by the Foster City, California-based company in July last year.

Gilead warned the public about HIV falsification on August 5, two weeks after the lawsuit was filed under seal.

The company accused 22 defendants of violating federal trademarks and New York Consumer Protection Laws for their roles in distributing “dangerous” counterfeits to “unsuspecting patients, endangering patients’ health and lives.”

Gilead said a common counterfeit was an antipsychotic drug that often causes drowsiness, with tablets being six times more potent than the US Food and Drug Administration recommended for some patients.

It said that a patient who unknowingly took the drug after receiving a fake bottle of Biktarvy reported that he could not talk or walk afterwards.

The lawsuit seeks, among other things, seizure of counterfeit substances, in addition to legalized seizures that have already taken place.

Global sales of their HIV treatments amounted to $ 4.19 billion in the quarter ended September 30, 2021, including $ 2.71 billion by Biktarvy and Descovy.

Lori Mayall, Gilead’s chief anti-counterfeiting leader, said the presiding judge in the lawsuit ordered the defendant distributors to stop selling Gilead-labeled drugs, and the company was unaware that any defendants were violating this order.

“We therefore believe that we have succeeded in stopping any further falsifications from these defendants when the patients,” Mayall said in a statement.

Reporting by Jonathan Stempel in New York and Manas Mishra and Jahnavi Nidumolu in Bengaluru; editing by Rosalba O’Brien and Jason Neely

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