VIENNA (Reuters) – An unnamed Novartis executive sold 925,400 Swiss francs ($ 946,000) worth of shares less than three weeks before the U.S. The Food and Drug Administration (FDA) announced data from tests for its gene therapy Zendixma had been manipulated.
FILE PHOTO: Swiss drug maker Novartis & # 39; logo is seen at the company's facility in the northern Swiss city of Stein, Switzerland on October 23, 2017. REUTERS / Arnd Wiegmann / File Photo
Novartis Announces Share Sale by an Executive Board Member or a member of the executive committee of a Swiss stock exchange filing dated July 19. The sale was first reported by the Swiss newspaper SonntagsZeitung on Sunday.
A Novartis spokesman told Reuters, "As is customary in such cases, the transaction was thoroughly checked in advance and then approved accordingly. He did not have relevant material information. "
The sale was made after the company informed the FDA about the data manipulation, but before the FDA announced it publicly on August 6.
Novartis shares fell almost 3 percent the day after the FDA announcement.
The FDA said this month that Novartis alerted regulators in June – more than a month after Z Thenma was approved – that some of the early test data had been tampered with.
The company had been aware of the problems as long as two months before the drug's US approval, the FDA said, and Novartis could face criminal or civil penalties.
Novartis said this month that it learned about data manipulation allegations in mid-March and completed a preliminary investigation into the allegations in early May, confirming data discrepancies and raising data privacy concerns.
The data was used to illustrate comparability between an early version of Zurtherma and the later version of the treatment, which was produced by another process.
The FDA said it does not believe that manipulation affects the safety or testing around the version of the drug, which treats spinal muscular atrophy (SMA), the leading genetic cause of death in infants.
Reporting by Francois Murphy; Editing by Alexandra Hudson