- The German company said its outside experts found “material breaches” of FDA standards while reviewing Akorn's operations.
Fresenius' decision is based on, among other factors, material breaches of FDA1 data integrity requirements relating to Akorn's operations found during Fresenius' independent investigation. 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.
- Fresenius confirms its guidance for 2018. The Group continues to expect a sales growth of 5% to 8% in constant currency. Group net income is expected to increase by 6% to 9%4 in constant currency (excluding expenditures for the further development of the biosimilars business around 10% to 13%5).
- Akorn responded to the announcement saying, "We categorically disagree with Fresenius' accusations. 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. We intend to vigorously enforce our rights, and Fresenius' obligations, under our binding merger agreement."
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