A pair of men from Ukraine admitted in federal court that they conspired to smuggle and distribute counterfeit cancer and hepatitis C drugs into the United States, according to a Department of Justice (DOJ) press release.

The DOJ reports that Maksym Nienadov, the owner of the Ukrainian-based company Healthy Nation, and his co-conspirator and employee – Volodymyr Nikolaienko – pleaded guilty in federal court in Houston, Texas to conspiracy, trafficking in counterfeit drugs and smuggling goods into the United States. Nienadov also admitted to introducing misbranded drugs into the United States.  

 The superseding indictment against the pair described both the nature of their crimes and how they were brought to justice. Nienadov setup Healthy Nation to market and distribute counterfeit versions of Abraxane and Keytruda, both oncology treatments, as well as Epclusa, a pill treatment for Hepatitis C. There was evidence they were selling or planning to sell fake versions of Iclusig, a cancer treatment, according to their plea agreement.

 After receiving a tip about Health Nation’s counterfeit drug business, undercover agents began to purchase the three drugs cited in the superseding indictment.  In each case, chemical analysis showed the purchased drugs were not what the defendants said they were.  In its genuine form, Keytruda is a cold-chain injectable used to treat multiple types of cancer.  Testing showed the Keytruda sold by Healthy Nation did not contain pembrolizumab, the correct  active ingredient, but instead, it was made from a class of chemicals known as proton-pump inhibitors: specifically omeprazole and/or pantoprazole. Omeprazole is known by its over-the-counter name Prilosec, and is used to treat acid reflux and heartburn. Pantoprazole is the active ingredient in Protonix, a prescription-only medication for treating acid reflux.

 To make their fake medications appear more genuine, Nienadov and Nikolaienko produced counterfeit packaging that mimicked the genuine product boxes and labels. In addition to using logos from the manufacturers of the genuine drugs, they either created fictitious lot numbers for the drugs, or copied genuine lot numbers from images of genuine drug boxes.

In April 2019, Nienadov and Nikolaienko flew to Houston to meet with the undercover agents posing as wholesale drug distributors.  The point of the meeting, the pair thought, was to plan an even larger drug sale. During the meeting, they promised the agents they could get them Russian or Italian Keytruda and put it in fake American packaging. All they needed was one genuine Keytruda box to make the fake ones.

Sentencing for Nienadov and Nikolaienko is set to take place on November 4, according to the DOJ.  Both men remain in custody, pending their sentencing hearing.

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