Akorn's FDA Violations Results in Termination of Acquisition And Remediation Costs of $900 Million
According to the complaint, on April 24, 2017, Fresenius SE Co. KGaA ("Fresenius") agreed to acquire Akorn in a deal valued at $4.3 billion. While conducting due diligence prior to the merger, Fresenius received three letters from whistleblowers alleging that Akorn's research and development facilities were significantly flawed and incomplete. Fresenius' subsequent investigation revealed that Akorn's board members hid the company's serious violations of U.S. Food and Drug Administration regulations, leading Fresenius to cancel the transaction in April 2018. When Akorn sued Fresenius to close the deal, the court ruled in favor of Fresenius, finding that Akorn "did not have a well-functioning quality system and lacked a meaningful culture of compliance." As a result, Akorn's market capitalization plunged from $4.3 billion when the merger was executed to only $720 million, and the company will need to pay an estimated $900 million to remediate its serious regulatory issues.
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