A French national will make his initial appearance today for his role in an attempt to fraudulently gain control of the rights to sell a weight-loss drug in the United States.
Alain Bouaziz, 68, a French citizen and resident of the United Arab Emirates, was arrested at Newark Liberty Airport while attempting to depart the United States.
U.S. Attorney Rachael A. Honig said Bouaziz is charged by complaint with making false statements to the U.S. Food and Drug Administration (FDA). He was scheduled to appear today by videoconference before U.S. Magistrate Judge Cathy L. Waldor.
According to documents filed in this case and statements made in court, Bouaziz is a French citizen and resident of the United Arab Emirates who represented himself to be the chief operating officer of Hexim Pharmaceuticals (Hexim), a company headquartered in Secaucus, New Jersey.
Hexim was known as Alkopharma USA Inc. until its name was changed in June 2013.
Beginning in February 2018, Bouaziz submitted forged documents and made false statements to the FDA to fraudulently gain control of Sanorex, a weight-loss pharmaceutical owned by NLS Pharma, a major international corporation identified in the complaint as Pharmaceutical Company-1.
Bouaziz sent letters and documents by email and in hard copy to the FDA falsely stating that Hexim had purchased the New Drug Application for Sanorex and requesting a meeting about marketing Sanorex in the United States.
Bouaziz knew these representations were false because Hexim had not purchased the rights to Sanorex from Novartis.
The documents that Bouaziz submitted to the FDA contained multiple forgeries and false statements, including one example where an earlier agreement between Alkopharma and Novartis had been altered to purport to show a sale of Sanorex to Hexim.
The false statements charge carries a maximum term of five years in prison and a fine of up to $250,000 or twice the gross gain or loss caused by the offense, whichever is greatest.
NLS Pharmaceutics Ltd., a Swiss clinical-stage pharmaceutical company, announced on March 12, 2021, that it had entered into a license agreement with Novartis Pharma AG to obtain, on an exclusive basis in the United States, all of the available data referred to and included in the original NDA for Sanorex submitted to the FDA in February 1972.
In 2009, Alkopharma acquired the antiemetic Navoban (tropisetron) from Novartis, which sold the rights to market Sanorex to NLS Pharma.
The companies did not disclose the price paid at that time, but Alkopharma claimed that it was investing $125 million in the acquisition of the product and the construction of two production facilities for anticancer and biological products.
NLS Pharmaceutics stock initially more than doubled in reaction to its License Agreement with Novartis Pharma AG, a unit of Novartis AG, wherein NLS secured an exclusive license to Sanorex (mazindol) in the U.S.
Sandoz developed Sanorex as an immediate-release obesity drug designed to shed pounds fast.
The March 2021 agreement encompasses all preclinical and clinical studies, data used for manufacturing, formulation data, and know-how for all products containing mazindol as an active substance, post-marketing clinical studies, and periodic safety reports.
Under the agreement, NLS has obtained the same rights on a non-exclusive basis outside the U.S., except for Japan.
The agreement includes the right to sublicense or assign the license to third parties but authorities say Hexim was not a part of any deal.