All signs point to a busy year for mergers and acquisitions, as several pharmaceutical industry chiefs have made it clear that they are on the lookout for new science. However, one executive took a rather different approach to building the pipeline – and he could serve up to five years in prison for it.
Alain Bouaziz, a 69-year-old French citizen and resident of the United Arab Emirates, pleaded guilty on Friday to making false statements to the FDA in an attempt to gain control of Novartis’ weight-loss drug, formerly marketed as Sanorex .
Bouaziz, who said he was the chief operating officer at Hexim Pharmaceuticals, was indicted in November after he falsely told the FDA that Hexim bought the NDA for Sanorex for $2 million. The rights to Sanorex actually belong to Novartis, which pulled the drug from the market in 2009, but not for “safety or efficacy reasons,” according to a Federal Register ruling.
Around the same time, Hexim (formerly known as Alkopharma) bought the commercial rights to another drug from Novartis in Europe, according to a complaint filed in November. Bouaziz was listed in public records as the company’s CEO. Alkopharma’s name was changed to Hexim in 2013, according to court documents. The company address is currently listed in Secaucus, NJ.
Beginning in February 2018, Bouaziz sent letters and documents to the FDA falsely claiming that Hexim had purchased the NDA for Sanorex and requested a meeting on marketing the drug in the United States. The FDA transferred the NDA to Hexim later that year. However, since the drug was discontinued, regulators have said Hexim cannot “market the product under this application and we will not accept supplements to this application,” according to court documents.
“If you are interested in continuing to market this product, contact this division to discuss your options,” the FDA wrote.
Novartis contacted the FDA after noticing that Sanorex’s listing in the agency’s Orange Book of Approved Products had been changed without its permission, and FDA officials launched an investigation.
Bouaziz faces a maximum sentence of five years in prison and a fine of up to $250,000, or “double the gross gain or loss caused by the offense, whichever is greater”. He is due to be sentenced on December 14, according to the Justice Department.
It is not known whether Bouaziz continues to work for Hexim. Terminal News has contacted the company, but has not received a response at press time.