Novartis axed Avexis execs ahead of Zolgensma scandal

The plot thickens at Novartis, which is becoming embroiled in a scandal over falsification of data related to its rare disease gene therapy Zolgensma.

It emerged yesterday that it replaced the two top executives at its Avexis unit, which conducted the preclinical development stages of the drug when the data manipulation allegedly happened.

Avexis chief scientific officer Brian Kaspar, and his brother and senior vice president of research and development Allan Kaspar have not been involved in any operations since early May 2019, Novartis said.

Brian was a founder of the company, who made more than $380 million when Novartis bought Avexis in an $8.7 billion deal signed last year.

The brothers have not commented publicly on the matter, and Novartis executive Page Bouchard took over their job on August 5.

Novartis' statement suggested that the brothers were replaced around the time of an internal investigation into Zolgensma, but well before the Swiss pharma notified the FDA about the issue in late June.

Most recently global head of preclinical safety for Novartis Institutes for BioMedical Research, Bouchard started his new role the day before the FDA announced it was considering criminal and civil penalties against Novartis for the faulty filing.

Novartis’ hoped that Zolgensma (onasemnogene abeparvovec) will start a revolution in gene therapy, as a highly expensive but highly effective treatment for the debilitating muscle wasting disease spinal muscular atrophy.

But it’s also got the Swiss pharma in a heap of trouble with regulators and politicians in the US after it emerged that scientists from the company that originally developed it manipulated preclinical data for the drug that costs more than $2 million.

Novartis added Zolgensma to its pipeline by acquiring Avexis in a deal that closed earlier this year but the problems relate to events that happened well before this when Zolgensma, originally codenamed AVXS-101 was under development in animal trials.

There is no suggestion that the clinical data used to support the filing has been manipulated, and currently there are no concerns about the safety and efficacy of the therapy.

Novartis said the data are limited to an animal assay not used in manufacturing the commercial product.

But the fact the suspect data was filed with the FDA, and that Novartis delayed notification until after the drug was approved, has caused the controversy.

Senate Finance Committee chair Chuck Grassley is investigating and has asked Novartis to give a detailed timeline of events.