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20 July 2020AmericasMuireann Bolger

Ukrainians plead guilty to trafficking counterfeit drugs into the US

Two citizens of  Ukraine have admitted to smuggling and distributing counterfeit cancer and hepatitis drugs into the US at the  Southern District Court of Texas on July 17, according to  the  US Department of Justice.

Maksym Nienadov, owner of Ukrainian-based company Healthy Nation, pleaded guilty to committing the offences alongside his co-conspirator and employee Volodymyr Nikolaienko. Nienadov also admitted to bringing misbranded drugs into the US.

In June 2018, the  Immigration and Customs Enforcement’s Homeland Security Investigations and  Food and Drug Administration (FDA)’s  Office of Criminal Investigations began a covert operation into the activities of both culprits. They began to communicate with them regularly regarding the illegal sale of counterfeit versions of the drugs Keytruda, Abraxane and Epclusa.

Merck & Co manufactures Keytruda, a medicine to treat cancer, while  Gilead Sciences manufactures Epclusa, a prescription drug for the treatment of hepatitis-C.  Celgene Corporation, a subsidiary of  Bristol Myers Squibb, manufactures the oncology product Abraxane. In their authentic form, the  US Food and Drug Administration (FDA) has approved all three drugs for distribution in the US.

During the investigation, the authorities transferred $2,400 to Nienadov’s bank account to buy the fake Keytruda, after which they received a shipment purportedly containing the cancer drug. But when the items were sent to Merck for testing, they were found to be counterfeit.

Authorities then bought purported Keytruda as well as another medication, Abraxane, leading to a $3,400 undercover payment to Nienadov. After the agents received the package on July 30 2018, Merck and Celgene carried out analyses and confirmed the packaging and medication to be fake.

In late 2018, the authorities also bought two boxes of purported Epclusa tablets from Nienadov and Nikolaienko for $6,000. Gilead identified the packaging and contents as counterfeit.

In 2019, Nienadov and Nikolaienko were invited to the US by undercover agents to discuss future unlawful shipments of pharmaceuticals, and were taken into custody on April 18 after they arrived.

Both men will remain in custody before being sentenced on November 4 before Chief Judge Rosenthal.

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