BERLIN (Reuters) - German healthcare group Fresenius SE (FREG.DE) said it had decided to pull out of its planned acquisition of Akorn (AKRX.O) after it found data integrity breaches at the U.S. generic drug maker.
Fresenius agreed last year to buy the U.S. maker of liquid generic drugs for about $4.75 billion, but said in February it could terminate the deal if its own independent probe found Akorn breached U.S. Food and Drug Administration data integrity requirements related to product development.
The German company said on Sunday its investigation had found “material breaches” of FDA data integrity requirements relating to Akorn’s operations.
“Fresenius offered to delay its decision in order to allow Akorn additional opportunity to complete its own investigation and present any information it wished Fresenius to consider, but Akorn has declined that offer,” it said in a statement.
A spokesman for Fresenius said Akorn had violated other requirements of the acquisition agreement, including its obligation to operate the business in the ordinary course after signing of the agreement, and it had not given Fresenius reasonable access to company information.
Akorn said it disagreed with Fresenius’ accusations and planned to enforce its rights and Fresenius’ obligations under the merger agreement.
“The previously disclosed ongoing investigation, which is not a condition to closing, has not found any facts that would result in a material adverse effect on Akorn’s business and therefore there is no basis to terminate the transaction,” it said in a statement.
Fresenius had hoped the acquisition of Akorn would help it offer a wider choice of drugs to hospitals and pharmacies.
Fresenius confirmed its guidance for adjusted group sales to rise between five and eight percent in constant currencies in 2018, with adjusted net income expected to increase between six and nine percent.
Earlier on Sunday, subsidiary Fresenius Medical Care (FMC) (FMEG.DE), cut its 2018 sales target.
Fresenius is due to report full first quarter results on May 3.
Reporting by Caroline Copley, Editing by Victoria Bryan, William Maclean