By Denise Roland 

Novartis AG has replaced two research executives at the unit that makes Zolgensma, the world's most expensive drug, in the wake of a data-manipulation scandal that surfaced a week ago.

The Swiss drug giant said Wednesday that Brian and Allen Kaspar, brothers who led research at the company's AveXis unit, hadn't been involved in any operations since early May and are no longer with Novartis.

Brian was chief scientific officer for AveXis and Allen was its head of research and development. Page Bouchard, a 10-year Novartis veteran, has assumed those roles, which have been combined.

Zolgensma, which costs $2.1 million for a one-time infusion, treats babies with a devastating inherited disease known as spinal muscular atrophy. The drug's rollout is being closely watched by investors as central to Novartis Chief Executive Vas Narasimhan's big bet on gene therapies -- treatments that provide a working copy of a faulty or missing gene, potentially curing rare diseases. Novartis spent $8.7 billion to acquire AveXis last year.

Last week, the U.S. Food and Drug Administration said data manipulation had taken place during company studies of Zolgensma, but that the drug should stay on the market as the manipulation involved a small portion of early-stage data on animals, rather than human clinical trials.

Dr. Narasimhan has said the issue came to light internally in mid-March and that Novartis decided to hold off alerting the regulator until the company had completed its own investigation.

Novartis told the FDA of the problem on June 28, a full month after Zolgensma got approved for sale by the agency. Dr. Narasimhan said that lag was unrelated to the approval timeline for Zolgensma.

Novartis has shared details of its findings with other regulators, which have yet to approve the treatment, and says it doesn't expect any regulatory delays in the wake of the disclosures.

In their roles at AveXis, the Kaspar brothers would have overseen the data that was submitted to the FDA to support Zolgensma's approval. Neither could immediately be reached for comment Wednesday.

Write to Denise Roland at Denise.Roland@wsj.com

 

(END) Dow Jones Newswires

August 14, 2019 13:30 ET (17:30 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.
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