Alleged data integrity breaches could lead to Fresenius pulling out of Akorn buy

Investors in Akorn (Nasdaq: AKRX) had a wake-up call yesterday, as Germany-based Fresenius raised doubts about its acquisition of Akorn amid a Food and Drug Administration enquiry into alleged allegations of FDA integrity requirements relating to product developments, sending the US drugmaker’s shares crashing 34.2% to $19.92 yesterday.

Fresenius proposed acquiring the USA-based manufacturer and marketer of prescription and over-the-counter pharmaceutical products in April last year, for around $4.3 billion, or $34.00 a share, plus the assumption of debt of about $450 million.

In a press statement, Akorn said: “Akorn and Fresenius Kabi AG, with the assistance of outside consultants, are investigating alleged breaches of FDA data integrity requirements relating to product development at the company. To date, the company’s investigation has not found any facts that would result in a material impact on Akorn’s operations and the company does not believe this investigation should affect the closing of the transaction with Fresenius. The company does not intend to provide further updates as the investigation proceeds. The company is continuing to work to obtain regulatory clearance for the transaction.”