The drugmaker said it found 85,247 bottles that had been tampered
with or faked, including versions of its Biktarvy and Descovy
treatments.
In a separate statement on Wednesday, Gilead said it has seized the
bottles of Gilead-labeled medication from 17 locations in nine
states as part of its investigation.
The investigation also uncovered unauthorized pharmaceutical
distributors who were selling the drugs to pharmacies, Gilead said.
Gilead said on Tuesday counterfeiters used authentic, but often
empty or near-empty, bottles that once contained its HIV medication.
It said the counterfeiters then substituted fake tablets and
documentation, and resealed the bottles so they would "resemble"
unopened, authentic bottles.
The alleged scheme was reported earlier by The Wall Street Journal.
Gilead disclosed its anti-counterfeiting efforts on the same day a
federal judge in Brooklyn unsealed a related civil lawsuit that the
Foster City, California-based company filed last July.
Gilead warned the public about HIV counterfeits on Aug. 5, two weeks
after filing the lawsuit under seal.
The company accused 22 defendants of violating federal trademark and
New York consumer protection laws for their roles in the
distribution of "dangerous" counterfeits to "unsuspecting patients,
placing the patients' health and lives at risk."
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Gilead said a common
counterfeit was an anti-psychotic drug that
often causes drowsiness, where tablets were six
times more potent than the U.S. Food and Drug
Administration recommended for some patients.
It said one patient who unknowingly took that drug after receiving a
fake bottle of Biktarvy reported being unable to speak or walk
afterwards. The lawsuit seeks, among other remedies,
the seizure of counterfeit drugs, in addition to court-ordered
seizures that have already occurred.
Global sales of its HIV treatments totaled $4.19 billion in the
quarter ending Sept. 30, 2021, including $2.71 billion of Biktarvy
and Descovy.
Lori Mayall, Gilead's top anti-counterfeiting executive, said the
presiding judge in its lawsuit ordered the defendant distributors to
stop selling Gilead-branded medications, and the company was unaware
of any defendant violating that order.
"We therefore believe that we have successfully stopped any
additional counterfeits from these defendants reaching 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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