Novartis blames former AveXis execs for Zolgensma data manipulation
pharmafile | September 25, 2019 | News story | Research and Development |
Novartis has placed blame on former executives Brian and Allan Kaspar for the manipulation of data behind its $2.1 million gene therapy Zolgensma, stating they either personally manipulated the data or forced subordinates to do so.
Novartis acquired AveXis, the company that developed the spinal muscular atrophy gene therapy, for $8.7 billion last year.
Novartis explained in its response letter, dated August 23rd, that the issue was related to mouse experiments conducted in 2017 and 2018 to compare the strength of Zolgensma manufactured at an Illinois plant to that previously produced at a children’s hospital in Ohio.
Novartis stated that the two executives “could not offer a credible explanation for revision to and inconsistencies in the data.”
Last month the US FDA said that Novartis could face civil or criminal penalties because of the data manipulation as well as the delay in notifying regulators.
John Hueston, a lawyer for Brian Kaspar, said in a statement: “AveXis shamelessly attempts to blame others for its own disclosure decisions to the FDA.
“Dr. Kaspar cooperated with the company investigation. Then and now, Dr. Kaspar has appropriately and categorically denied all wrongdoing.”
Novartis has pointed out that the company has had technical experts examine each discrepancy to assess its impact on the underlying studies, and “in each case, these technical reviews found that the data manipulation issues had no impact on patient safety or product efficacy or quality.”
In light of the controversy, Novartis pledged that it will inform the FDA of any “credible allegation” concerning data integrity that could affect a pending marketing application within five business days and additionally has created a new data integrity officer position to monitor such things produced by its AveXis unit.
Nik Kiran
