Novartis Replaces Two Researchers Amid Data Scandal
August 14 2019 - 01:45PM
Dow Jones News
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.
Novartis (NYSE:NVS)
Historical Stock Chart
From Feb 2024 to Mar 2024
Novartis (NYSE:NVS)
Historical Stock Chart
From Mar 2023 to Mar 2024