NEW YORK, Sept 24 (Reuters) - Novartis AG laid the blame for the manipulation of data behind its $2.1 million gene therapy Zolgensma at the feet of the former executives Brian and Allan Kaspar, who it alleges either personally manipulated the data or pressured subordinates to manipulate the data.
The Kaspar brothers were executives at Avexis, the company that developed the drug and was acquired by Novartis for $8.7 billion last year.
Last month, the U.S. Food and Drug Administration said Novartis could face civil or criminal penalties because of the data manipulation and the possibility the company had waited to notify regulators.
The new allegations were in Novartis’ response to the FDA’s inspection report. They were written by the company in late August and released by the regulator on Tuesday.
Representatives for the Kaspars could not be immediately reached for comment.
After its investigation Novartis fired Avexis’ Chief Scientific Officer Brian Kaspar and Senior Vice President of Research and Development Allan Kaspar for cause on Aug. 13.
The company also said its internal investigation was drawn out because of the Kaspars’ “lack of cooperation and categorical denial of the allegations.”
Zolgensma - the world’s most expensive drug - was approved as a one-time treatment for spinal muscular atrophy (SMA) in late May.
The disease often leads to paralysis, breathing difficulty and death within months for babies born with the most serious Type I form. SMA affects about one in 10,000 live births, with 50% to 70% having Type I disease, and is the leading genetic cause of death in infants. (Reporting by Michael Erman; Editing by David Gregorio)