Ukrainian Men, Who Conspired To Smuggle Counterfeit Cancer, Hepatitis Drugs Into US, Plead Guilty

Two Ukrainian men pleaded guilty to conspiring to smuggle counterfeit cancer and hepatitis drugs into the United States on Friday, July 17.

Maksym Nienadov, the owner of Ukrainian-based company Healthy Nation, and his employee, 33-year-old Volodymyr Nikolaienko, pleaded guilty to conspiracy and trafficking in counterfeit drugs, a press release from the Department of Justice said. Neither of the accused were doctors, pharmacists or licensed pharmaceutical wholesalers in the U.S.

In June 2018, an undercover agent contacted Nienadov regarding the illegal sale of Keytruda, a medicine to treat cancer manufactured by Merck & Co. A months-long exchange resulted in the illegal sale of counterfeit or unapproved Keytruda, Abraxane (drug for cancer treatment) and Epclusa (drug to treat hepatitis-C).

"During the undercover investigation, law enforcement received Nienadov’s banking information, which included the name ‘Maksim Nenadov’ and his Ukrainian bank account number. Authorities transferred $2,400 to his bank account for the purchase of the purported Keytruda. Soon after, they received a shipment from 'Maxim Nenadov' which contained two boxes represented to contain Keytruda. However, the items were sent to Merck for testing and determined to be counterfeit," the press release said.

"Authorities then negotiated the purchase of more Keytruda as well as another medication, Abraxane. The online messaging and email conversations resulted in a $3,400 undercover payment to Nienadov for the purchase of both drugs. On July 30, 2018, 'Maxim Nenadov' sent two boxes of 50 mg purported Keytruda and two boxes of supposed Abraxane 5 mg/ml to undercover agents," the press release added. Analysis confirmed that the medication was counterfeit.

When the men arrived in the U.S. in April, 2019, to "discuss future unlawful shipments of pharmaceuticals," they were taken into custody. On July 17, they pleaded guilty to conspiracy, trafficking in counterfeit drugs and smuggling goods into the U.S. Their sentencing was scheduled for Nov. 4, and the two will remain in custody pending that hearing.

The investigation was conducted by the Immigration and Customs Enforcement’s Homeland Security Investigations and FDA’s Office of Criminal Investigations.