executive sold shares before drug data manipulation made
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[August 19, 2019]
VIENNA (Reuters) - An unnamed Novartis
executive sold 925,400 Swiss francs ($946,000) worth of shares less than
three weeks before the U.S. Food and Drug Administration (FDA) announced
data from tests of its gene therapy Zolgensma had been manipulated.
Novartis announced the stock sale by an executive member of the
board of directors or a member of the executive committee in a Swiss
stock exchange filing dated July 19. The sale was first reported by
Swiss newspaper SonntagsZeitung on Sunday.
A Novartis spokesman told Reuters, "As is usual in such cases, the
transaction was thoroughly checked beforehand and then approved
accordingly. The person in question was not in possession of
relevant material information."
The sale was made after the company had informed the FDA about the
data manipulation but before the FDA announced it publically on Aug
Shares in Novartis fell almost 3 percent the day after the FDA
The FDA said this month that Novartis notified regulators in June -
more than a month after Zolgensma had been approved - that some of
the early testing data had been manipulated.
The company had been aware of the problems for as long as two months
before the drug's U.S. approval, the FDA said, and Novartis could
face criminal or civil penalties.
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Novartis said this month that it learned of allegations of data
manipulation in mid-March and finished a preliminary investigation
into the allegations in early May, confirming data discrepancies and
raising data integrity concerns.
The data was used to illustrate comparability between an early
version of Zolgensma and the later version of the treatment, which
was manufactured using a different process.
The FDA said it does not believe that the manipulation impacts the
safety or testing surrounding the version of the drug, which treats
spinal muscular atrophy (SMA), the leading genetic cause of death in
(Reporting by Francois Murphy; Editing by Alexandra Hudson)
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