Department of Justice
U.S. Attorney’s Office
Southern District of Texas
FOR IMMEDIATE RELEASE
Thursday, March 25, 2021
HOUSTON - Two citizens of Ukraine have been sentenced after admitting they conspired to smuggle and distribute counterfeit cancer and hepatitis drugs into the United States.
Maksym Nienadov, 36, is the owner of the Ukrainian-based company Healthy Nation. He and his co-conspirator and employee – Volodymyr Nikolaienko, 34 – pleaded guilty to conspiracy, trafficking in counterfeit drugs and smuggling goods into the United States July 17, 2020. Nienadov also admitted to introducing misbranded medicine into the United States.
Today, Nienadov and Nikolaienko were sentenced to respective terms of 71 and 33 months in federal prison. They are both expected to face removal proceedings following the prison terms.
“The defendants sought to profit off the illnesses of others, selling false hope – including fake drugs with no active ingredient – and risking the health of vulnerable patients,” said Acting Assistant Attorney General Nicholas L. McQuaid of the Justice Department’s Criminal Division. “This prosecution makes clear that we will hold accountable those who disregard the risks to patients by smuggling counterfeit drugs into the United States.”
“Those that traffic counterfeit drugs pose harm to our country’s most vulnerable citizens and will face consequences,” said Acting U.S. Attorney Jennifer B. Lowery. “Defenseless people need their medications for life-threatening illnesses. Schemes like these put patients at risk of not receiving the actual drugs required for treatment. This prosecution demonstrates the tremendous work by all our partners and our collaborative commitment to protecting our community and combatting counterfeit drug trafficking 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 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 an 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.
“Selling illegal prescription drugs in the U.S. marketplace puts consumers’ health at risk, but it is especially reprehensible when the drugs are intended for use with especially vulnerable populations, such as cancer patients,” said Special Agent in Charge Charles L. Grinstead of the Food and Drug Administration, Office of Criminal Investigations (FDA-OCI) - Kansas City Field Office. “We will continue to investigate and bring to justice those who sell illegal prescription drugs, knowing that they can jeopardize patients’ health.”
“We work tirelessly, alongside our federal partners and private sector stakeholders, to prevent counterfeit pharmaceuticals from infiltrating the American marketplace,” said Special Agent in Charge Mark Dawson of Immigration and Customs Enforcement’s Homeland Security Investigations (HSI), Houston. “Today’s sentencing is another example of our relentless efforts to ensure consumers are receiving the life-saving pharmaceuticals that they need to treat their afflictions.”
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. They have been and will remain in custody pending transfer to a U.S. Bureau of Prisons facility to be determined in the near future.
HSI and FDA-OCI conducted the investigation.
Assistant U.S. Attorney Sebastian Edwards and Senior Trial Attorney Jeffrey Pearlman of the Criminal Division’s Computer Crime and Intellectual Property Section (CCIPS) prosecuted the case. Former CCIPS Senior Trial Attorney Kebharu Smith assisted in the prosecution. In addition, the Criminal Division’s Office of International Affairs provided substantial assistance.
USAO - Texas, Southern