Fresenius focuses on data, computer lapses at Akorn in trial over $4.3B deal

A trial in Delaware will determine if Fresenius can cancel its $4.3 billion deal with Akorn, but some analysts predict the deal with close at a lower price. (Matthew Henry/Burst)

A trial which will determine whether Germany’s Fresenius can cancel its $4.3 billion deal to buy out U.S. generics maker Akorn is focused on lapses in Akorn’s computer and data integrity. Fresenius says it is justified in killing the deal, while Akorn counters that Fresenius has buyer’s remorse, adding that the concerns are small deals and common among drugmakers and third-world companies.

Citing a lawyer for Fresenius, Bloomberg reported that experts Akorn brought in after the computer issues were uncovered by the FDA both testified in this week’s trial that Akorn had almost no oversight. According to lawyer Lewis Clayton, Akorn consultant John Avellanet, testified “anyone in the company could get into that system and modify the records with no accountability.”

RELATED: Fresenius' $4.3B buyout of Akorn threatened by data integrity probe

Free Webinar

Building a Flexible, Challenge Resistant and Patient Centric Clinical Supply Chain

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. In this webinar, learn the benefits of utilizing demand-led supply and direct-to-patient distribution models in the clinical supply chain, as well as how they can be used to both improve flexibility and better align with patient needs. Register today!

Zena Kaufman, a former head of quality control at Hospira and another Akorn consultant, testified the computer security problems were the worst she had ever seen, Bloomberg reported. There was testimony that Akorn tried to cover up the lapses.

The FDA has been carefully monitoring computer and data security and audit trails at drugmakers for a decade since it uncovered problems at Ranbaxy Laboratories, once the largest Indian generics maker and a key supplier to the U.S. The FDA was criticized at the time for being unaware of the Ranbaxy data manipulations until a whistleblower from the company came forward. 

RELATED: Fresenius oncology drug plant slammed with new warning letter

Since then, the FDA has been on the alert for computer security and data integrity. In fact, an Indian plant owned by Fresenius, was savaged with a warning letter in 2013 after FDA investigators found that employees had actually been removing computer equipment from the plant ahead of a FDA inspections to hide data manipulation.

While the trial will determine if Fresenius can cancel its deal, some analysts think it will still get done but at a much reduced price.

Suggested Articles

In a departure from the usual approval process, the FDA says it doesn't require manufacturing inspections before weighing vaccines for emergency use.

Sanofi and Regeneron released follow-up data from a phase 3 trial for immunology blockbuster Dupixent in an eosinophilic esophagitis.

Singapore has suspended the use of two flu vaccines, from SK Bioscience and Sanofi, amid reports of deaths in South Korea after immunization.