FILE PHOTO: Swiss drugmaker Novartis’ logo is seen at the company’s plant in the northern Swiss town of Stein, Switzerland October 23, 2017. REUTERS/Arnd Wiegmann
NEW YORK (Reuters) – Novartis said on Wednesday the two top research & development executives at its Avexis unit were no longer at the company after some data from early testing of Avexis’s more than $2-million gene therapy Zolgensma was manipulated.
Avexis’ Chief Scientific Officer Brian Kaspar – a founder of the company – and Senior Vice President of Research and Development Allan Kaspar have not been involved in any operations at Avexis since early May 2019, Novartis said in a statement. The Kaspars are brothers.
Page Bouchard has taken on the roles of senior vice president of research and chief scientific officer of Avexis as of Aug. 5, Novartis said.
The U.S. Food and Drug Administration said last week that Novartis had 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 many as two months before the drug’s U.S. approval, the FDA said, and it could face criminal or civil penalties.
Novartis acquired Avexis in April 2018, paying $8.7 billion for the maker of the rare-disease treatment, which is expected to bring in billions of dollars in sales.
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 Franklin Paul and Bernadette Baum