Aegerion Pharmaceuticals, Inc., an American biopharmaceutical company, engages in the development and commercialization of therapeutics/pharmaceuticals to treat cardiovascular and metabolic diseases.
In late 2013, Aegerion Pharmaceuticals, Inc. received a subpoena from the DOJ requesting documents regarding the marketing and sale of JUXTAPID (the brand name for the pharmaceutical lomitapide) in the U.S., as well as related disclosures. According to Aegerion's SEC filings, Aegerion believes the DOJ is seeking to determine whether the company, or any of its current or former employees, violated civil and/or criminal laws, including, but not limited to, the securities laws, the Federal False Claims Act, the Food and Drug Cosmetic Act and the anti-Kickback Statute. Aegerion's later filings also indicate that the DOJ may be seeking to determine whether the company vioated the FCPA.
In 2014, Aegerion disclosed that federal and Sao Paolo authorities in Brazil are each conducting an investigation to determine whether there have been any violations of Brazilian anti-corruption laws in connection with prescriptions for lomitapide written in Brazil. The company also disclosed that based on its investigation as of August 2014, it does not believe that a violation of Brazilian anti-corruption laws has occurred.
In late 2014, Aegerion received a subpoena from the SEC requesting certain information related to the company's sales activities and disclosures related to JUXTAPID. The SEC also requested documents and information on a number of other topics, including documents related to whether the company's activities in Brazil violated Brazilian anti-corruption laws or the U.S. Foreign Corrupt Practices Act. In its SEC filings, Aegerion disclosed that it believes the SEC is seeking to determine whether the company, or any of their current or former employees, violated securities laws.
Aegerion said it cooperated with the investigations.
In its May 16, 2016 10-Q, Aegerion disclosed that it has reached preliminary agreements in principle with the DOJ and the SEC to resolve certain aspects of their ongoing investigations. However, the agreements do not cover the DOJ and SEC’s inquiries concerning the company’s operations in Brazil.
In its November 4, 2016 10-Q, Aegerion announced that it was merging with a subsidiary of QLT Inc. and that the resulting company would be renamed Novelion Therapeutics Inc. Novelion continued to make disclosures about the investigation.
On September 22, 2017, Novelion reached settlements with the DOJ and SEC regarding the company's statements and disclosures related to JUXTAPID. The settlement with the DOJ appears to have concluded the DOJ's investigation into the company, and it is unclear whether the DOJ ever investigated Aegerion for FCPA violations, as that was not part of the settlement.
Filings after the reported dates of the DOJ and SEC settlements noted that the SEC settlement did not include the FCPA portions of the investigation, and the company's 10-K filed on March 15, 2019, indicated that the SEC investigation might have still been open. However, the company's most recent 10-K does not appear to contain the same language. In September 2019, Amryt Pharma plc purchased Aegerion upon Aegerion's emergence from Chapter 11 bankruptcy. Amryt's filings do not include language about Aegerion's FCPA investigation, so the Clearinghouse presumes that the SEC's investigation is indeed closed.
