VIENNA (Reuters) – An unnamed Novartis executive sold less than three weeks before the US Food and Drug Administration's data on the manipulation of data from its gene therapy tests, Zolgensma, was published in the US Value of 925,400 Swiss francs (946,000 US dollars).
FILE PHOTO: The logo of the Swiss drug company Novartis can be seen on October 23, 2017 at the company's plant in the northern Swiss city of Stein. REUTERS / Arnd Wiegmann / File Photo
Novartis announced the sale of shares by an executive member of the board of directors or a member of the executive board in a Swiss exchange application dated 19 July. The sale was first reported on Sunday by the Swiss SonntagsZeitung.
A Novartis spokesman told Reuters, "As is customary in such cases, the transaction was previously thoroughly audited and subsequently approved. The person concerned had no relevant material information.
The sale took place after the company informed the FDA about the data manipulation, but before the FDA publicly announced it on August 6.
Novartis shares fell nearly 3 percent the day after the FDA announcement.
The FDA said this month that Novartis had notified regulators in June – more than a month after Zolgensma's approval – that some of the early test data had been tampered with.
The company was aware of the issues two months before the drug's US approval, and Novartis could have criminal or civil consequences.
Novartis announced this month that it received allegations of data manipulation in mid-March and completed a preliminary investigation into the allegations in early May confirming data bias and voicing concerns about data integrity.
The data were used to illustrate the comparability between an early version of Zolgensma and the later version of the treatment made by another method.
The FDA said it does not believe that the manipulation interferes with the safety or testing of the version of the drug that treats Spinal Muscular Atrophy (SMA), the most common genetic cause of death in infants.
Reporting by Francois Murphy; Edited by Alexandra Hudson