Houston, Texas - Two citizens of Ukraine have admitted they conspired to smuggle and distribute counterfeit cancer and hepatitis drugs into the United States, announced Acting Assistant Attorney General Brian C. Rabbitt and U.S. Attorney Ryan K. Patrick of the Southern District of Texas.
Maksym Nienadov, 36, is the owner of the Ukrainian-based company Healthy Nation. He and his co-conspirator and employee – Volodymyr Nikolaienko, 33 – pleaded guilty today to conspiracy, trafficking in counterfeit drugs and smuggling goods into the United States. Nienadov also admitted to introducing misbranded drugs into the United States.
In June 2018, undercover U.S. authorities began communicating with Nienadov about the illegal sale of Keytruda. This prompted a months-long exchange which also involved Nikolaienko and resulted in the unlawful sale of counterfeit or unapproved Keytruda, Abraxane and Epclusa. Neither Nienadov nor Nikolaienko are medical doctors, pharmacists or licensed pharmaceutical wholesalers in the United States and did not have authorization to sell the drugs.
Merck & Co. manufactures Keytruda, a medicine to treat cancer, while Gilead Sciences Inc. manufactures Epclusa, a prescription drug for the treatment of hepatitis-C. Celgene Corporation is a wholly-owned subsidiary of Bristol Myers Squibb and manufactures the oncology product Abraxane. In their legitimate form, the U.S. Food and Drug Administration (FDA) approved all three drugs for distribution in the United States.
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.
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. Merck and Celgene performed analyses and confirmed the packaging and medication to be counterfeit.
In late 2018, law enforcement also negotiated the undercover purchase of two boxes of purported Epclusa tablets from Nienadov and Nikolaienko for $6,000. Gilead identified the packaging and contents as counterfeit.
Nienadov and Nikolaienko were taken into custody April 18, 2019, after they arrived in the United States from Ukraine to discuss future unlawful shipments of pharmaceuticals.
U.S. Magistrate Judge Christina A. Bryan took the pleas today. Sentencing has been set for Nov. 4, 2020 before Chief Judge Rosenthal. Both men will remain in custody pending that hearing.
Immigration and Customs Enforcement’s Homeland Security Investigations and FDA’s Office of Criminal Investigations conducted the investigation.
Senior Trial Attorney Jeffrey Pearlman of the Criminal Division’s Computer Crime and Intellectual Property Section (CCIPS) and Assistant U.S. Attorney Sebastian Edwards of the Southern District of Texas are prosecuting the case. Former CCIPS Senior Trial Attorney Kebharu Smith assisted in the prosecution. In addition, the Criminal Division’s Office of International Affairs and the Office of the Prosecutor General of Ukraine provided substantial assistance.