Alexion Pharmaceuticals Inc. said in a securities filing that the Justice Department is now investigating the company’s grant-making activities and its compliance with the Foreign Corrupt Practices Act.
Connecticut-based Alexion received a subpoena from the SEC in May. The company said the DOJ in October asked for the voluntary production of documents related to the investigation.
Alexion is best known for its development of Soliris, a drug used to treat the rare blood and kidney disorders. Soliris is approved for use in more than 50 countries. The company has about 3,000 employees around the world.
Alexion said the SEC also asked for information about the company’s recalls of specific lots of Soliris and related securities disclosures.
The company said it can’t yet estimate the scope or duration of the investigation or predict the outcome or potential costs.
In a statement emailed to the Wall Street Journal, Alexion said:
We are fully cooperating with the investigations. Alexion has long been committed to operating at the highest level of business ethics worldwide and has a robust global compliance program.
The SEC and DOJ typically don’t comment about ongoing FCPA investigations.
Alexion Pharmaceuticals, Inc. trades on Nasdaq under the symbol ALXN.
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Here’s the full FCPA disclosure from Alexion’s Form 10-Q filed with the SEC on November 2, 2015:
As previously disclosed, in May 2015, we received a subpoena in connection with an investigation by the Enforcement Division of the U.S. Securities and Exchange Commission (SEC) requesting information related to our grant-making activities and compliance with the Foreign Corrupt Practices Act (FCPA) in various countries.
The SEC also seeks information related to Alexion’s recalls of specific lots of Soliris and related securities disclosures.
In addition, in October 2015, Alexion received a request from the U.S. Department of Justice for the voluntary production of documents and other information pertaining to Alexion’s compliance with the FCPA.
Alexion is cooperating with these investigations.
At this time, Alexion is unable to predict the duration, scope or outcome of these investigations. Given the ongoing nature of these investigations, management does not currently believe a loss related to these matters is probable or that the potential magnitude of such loss or range of loss, if any, can be reasonably estimated.
Richard L. Cassin is the publisher and editor of the FCPA Blog. He can be contacted here.