In a brief announcement, AveXis said the Kaspar brothers have not been involved in any operations at AveXis since early May, seemingly ahead of the U.S. Food and Drug Administration’s approval of Zolgensma.
AveXis has parted ways with its scientific founder and chief scientific officer as the Illinois-based gene therapy business and its parent company, Novartis, continue to grapple with the fallout over reports of data manipulation in the development of the spinal muscular atrophy treatment, Zolgensma.
Today, AveXis revealed that Brian Kaspar and Allan Kaspar, the company’s head of research and development, are no longer with the company. In a brief announcement, AveXis said the Kaspar brothers have not been involved in any operations at AveXis since early May, seemingly ahead of the U.S. Food and Drug Administration’s approval of Zolgensma.
The move was not unexpected as Novartis entered crisis management to contain another scandal. In a call with investors, Novartis Chief Executive Officer Vas Narasimhan said that “a small number of scientists” who were involved with the manipulation would be terminated.
Taking over for the Kaspars will be Page Bouchard, a longtime veteran of the pharma industry. In the announcement, Novartis and AveXis point to Bouchard’s successful record in drug development. Bouchard, who has been with Novartis for the past 10 years, has been involved with “well over 100 Investigational New Drug programs and dozens of New Drug Application/Biologics License Application filings,” the Swiss pharma giant said in its announcement. Bouchard most recently served as the global head of Preclinical Safety for Novartis Institutes for BioMedical Research.
Last week, the FDA revealed that data manipulation was involved in the preclinical process of Zolgensma’s development. The agency revealed that the data manipulation was “limited to only a small portion of the product testing data that was contained in the marketing application.” However, that testing data was used by AveXis to support the development of its production process, the FDA said. The FDA did note in its announcement that AveXis knew about the manipulation ahead of the agency’s approval of the gene therapy. AveXis only notified the FDA about the manipulation following the regulatory approval.
The revelation of the data manipulation, plus the $2.1 million list price tag for Zolgensma, has raised the ire of multiple federal lawmakers, including Democratic presidential candidates Sens. Bernie Sanders and Elizabeth Warren. The senators, along with other colleagues from the upper chamber of Congress, issued letter to the FDA demanding that the regulatory agency take action against AveXis. In the letter to the FDA, the senators called it “unconscionable” that the falsified data would be submitted for the approval process, particularly since the gene therapy was initially researched with funding from the federal government. The senators urged the FDA to hold AveXis accountable “through all appropriate criminal, civil and regulatory actions against the company” in order to “restore public confidence in the agency’s approval process.”
“It is unconscionable that a drug company would provide manipulated data to federal regulators in order to rush its product to market, reap federal perks, and charge the highest amount in American history for its medication. Such greed cannot be condoned by the FDA,” the senators said in the letter.
Novartis acquired AveXis last year for $8.7 billion. The parent company has stood behind the data submitted to the FDA. In its support of the gene therapy, Novartis said the assays that were in question regarding the data manipulation were used for initial product testing but are not currently used for commercial product release.
