Novartis' former weight loss med Sanorex at center of New Jersey pharma chief's guilty plea

After being charged with deceiving the FDA last fall, purported New Jersey pharma CEO Alain Bouaziz had his day in court. Now, the 69-year-old French citizen faces up to five years in prison—plus a maximum fine of $250,000—over a plot to get his hands on Novartis’ former weight loss med Sanorex.

Bouaziz submitted forged documents and made false statements to the FDA in a bid to “fraudulently gain control of Sanorex,” a stimulant-based weight loss drug that Novartis pulled from the market more than 10 years ago, the DOJ says. The Swiss pharma’s Sanorex withdrawal didn’t have to do with safety or effectiveness, according to a federal register determination.

Bouaziz, who is also a resident of the United Arab Emirates, pled guilty to the November 2021 charges in a Newark federal court this month, according to a recent release from the U.S. Department of Justice (DOJ).

Bouaziz “represented himself” as the chief executive of Hexim Pharmaceuticals, which lists its headquarters in Secaucus, New Jersey, according to legal filings and court statements cited in the DOJ release. Hexim previously went by the name Alkopharma USA.

Around October 2009—the same year Sanorex was officially removed from U.S. shelves—Hexim, then known as Alkopharma, had bought from Novartis the rights to a different drug in Europe, according to the federal case against Bouaziz.

Then, starting in 2018, Bouaziz sent letters and documents via email and in hard copy to the FDA falsely stating Hexim had purchased the new drug application for Sanorex. In turn, the company also asked the regulator to schedule a meeting to discuss the drug's status in the U.S. At no point did Hexim or Alkopharma own the rights to distribute Sanorex, DOJ notes.

In one instance, a document sent to the FDA by Bouaziz altered an earlier agreement between Alkopharma and Novartis “to purport to show a sale of Sanorex to Hexim,” DOJ said in a release last year when it lodged its charges against Bouaziz.

For making false statements to the FDA, Bouaziz faces up to five years in prison. He’ll also be on the hook to pay a maximum fine of $250,000 or twice the gross gain or loss caused by the offence, depending on whichever is greatest, the DOJ explained.

Sentencing in Bouaziz's case is schedule for Dec. 14.

The DOJ has had a busy few years busting up pharmaceutical malfeasance. Back in May, pharmacy operator Arkadiy Khaimov was sentenced to 51 months in prison for defrauding an unnamed pharmaceutical manufacturer of roughly $7.2 million. Khaimov’s scheme revolved around the submission of bogus claims under the manufacturer’s co-pay coupon program, DOJ said at the time. 

Last summer, meanwhile, Racho Jordanov and Rose Lin, the two co-founders and former top execs at Taiwanese outfit JHL biotech, pled guilty to charges of wire fraud and conspiring to steal trade secrets from Roche's Genentech.

Novartis has found itself in the DOJ's sights in recent months. Back in September, the Swiss pharma was slapped with a request from the DOJ asking for information about the marketing and pricing of heart failure med Entresto from 2016. That DOJ subpoena, which doesn't indicate a formal litigation process, came a year after Novartis wrapped up doctors’ kickback allegations with a $678 million settlement.