Novartis executive sold stock before drug data was released

VIENNA (Reuters) – An unidentified Novartis executive has sold 925,400 Swiss francs ($ 946,000) in stock less than three weeks before the Food and Drug Administration (FDA) announced data manipulation.

Novartis announced the sale of the shares by an executive member of the board of directors or a member of the executive committee in a publication on the Swiss stock exchange dated July 19. This sale was first reported by the Swiss newspaper SonntagsZeitung on Sunday.

A Novartis spokesman told Reuters: "As is customary in such cases, the transaction has been thoroughly checked beforehand and approved accordingly. The person in question was not in possession of relevant material information. "

The sale was made after the company informed the FDA of the data manipulation, but before the FDA publicly announced it on August 6.

Novartis shares fell nearly 3% the day after the FDA announcement.

The FDA announced this month that Novartis had informed regulators in June – more than a month after Zolgensma's approval – that some of the early test data had been manipulated.

The FDA said the company had been aware of the problems for two months before the drug's approval, and that Novartis could face criminal or civil penalties.

Novartis announced this month that it had learned of data manipulation allegations in mid-March and closed a preliminary investigation into the allegations in early May, confirming data discrepancies and raising concerns about their integrity.

The data was used to illustrate the comparability between a first version of Zolgensma and the later version of the treatment, which was manufactured using a different process.

The FDA has said it does not believe that tampering has an impact on safety or testing surrounding the version of the drug, which treats spinal muscular atrophy (SMA), the leading genetic cause of death in infants.