Log in
Forgot password ?
Become a member for free
Sign up
Sign up
Dynamic quotes 

MarketScreener Homepage  >  Equities  >  Swiss Exchange  >  Novartis    NOVN   CH0012005267


News SummaryMost relevantAll newsOfficial PublicationsSector newsMarketScreener StrategiesAnalyst Recommendations

Novartis : Pledges More Transparency on Data Concerns

share with twitter share with LinkedIn share with facebook
share via e-mail
09/09/2019 | 12:39pm EDT

By Denise Roland

Novartis AG, under fire for keeping a data-manipulation issue under wraps for several months, vowed to more quickly disclose any similar concerns in the future.

Chief Executive Vas Narasimhan on Monday told investors at an event in London that Novartis has committed to notify the Food and Drug Administration within five business days of any "credible allegation" of manipulation of data that had been submitted to the agency for drug approval.

The FDA last month said the Swiss company could face criminal penalties for holding back a data-manipulation concern with gene therapy medicine Zolgensma during its approval process. Novartis notified the FDA of the concern in late June, a month after the drug was approved, despite the issue being known inside the company since the middle of March.

Dr. Narasimhan has said the company wanted to investigate the specifics of the manipulation before bringing the concern to the agency. He said he was made aware of the issue in early May after an initial investigation found the allegations were credible.

But the timeline of those decisions has raised suspicions from the agency, and some politicians, that Novartis kept the issue under wraps because it didn't want to delay the approval of Zolgensma.

The medicine, which costs in the range of $2.1 million for a one-time infusion, treats children with an especially devastating, sometimes fatal form of spinal muscular atrophy. It is one of the first in a wave of gene therapies that promise to cure certain intractable diseases with one dose. They work by supplying a functioning version of the gene at fault.

The FDA gave Novartis the green light to sell Zolgensma in late May and the company put it on sale at a price of $2.1 million, making it the world's most expensive drug. Dr. Narasimhan has said the approval timeline for Zolgensma wasn't a factor.

"It's difficult for us to exercise judgment without it being later considered maybe not the best judgment, so we're just taking judgment out of the equation," Dr. Narasimhan said of the five-day pledge at the investor event, which focused environmental, social and corporate governance.

The FDA has said the data manipulation, which related to mouse studies carried out to compare different batches of Zolgensma, didn't affect its view that the gene therapy is safe and effective. It referred the matter to its Office for Criminal Investigations. Submitting false data to the agency as part of a new-drug application could be a crime if investigators prove the actions were intentional and not an oversight.

The episode has also drawn criticism from several high-ranking politicians including Democratic presidential candidates Sens. Elizabeth Warren of Massachusetts and Bernie Sanders of Vermont, and Sen. Chuck Grassley (R., Iowa).

Write to Denise Roland at Denise.Roland@wsj.com

share with twitter share with LinkedIn share with facebook
share via e-mail
Latest news on NOVARTIS
03:13pDR REDDY LABORATORIES : . Reddy's Suspends Shipments of Ranitidine
10:35aNOVARTIS : AveXis presents new data at EPNS continuing to show significant thera..
09/18NOVARTIS : Sandoz Halting Ranitidine Distribution
09/18NOVARTIS : halts distribution of its Zantac versions amid probe into impurities
09/18NOVARTIS : Cosentyx positive 16-week PREVENT results advance potential new indic..
09/17NOVARTIS : Initiation of Novartis Entresto in-hospital included in the new ACC E..
09/17NOVARTIS : CHF0.50(REGD) Novartis Cosentyx(R) -2-
09/17NOVARTIS : CHF0.50(REGD) Novartis Cosentyx(R) Positive 16-week Prevent Results A..
09/16NOVARTIS : New Novartis data show that neuronal and glial filaments, biomarkers ..
09/14NOVARTIS : Trial and Error -2-
More news
Financials (USD)
Sales 2019 47 003 M
EBIT 2019 13 855 M
Net income 2019 10 274 M
Debt 2019 17 463 M
Yield 2019 3,44%
P/E ratio 2019 18,6x
P/E ratio 2020 20,3x
EV / Sales2019 4,58x
EV / Sales2020 4,22x
Capitalization 198 B
Duration : Period :
Novartis Technical Analysis Chart | MarketScreener
Full-screen chart
Technical analysis trends NOVARTIS
Short TermMid-TermLong Term
Income Statement Evolution
Mean consensus OUTPERFORM
Number of Analysts 25
Average target price 94,55  $
Last Close Price 86,26  $
Spread / Highest target 24,6%
Spread / Average Target 9,62%
Spread / Lowest Target -5,50%
EPS Revisions
Vasant Narasimhan Chief Executive Officer
Hans Jörg Reinhardt Independent Non-Executive Chairman
Harry Werner Kirsch Chief Financial Officer
John Tsai Chief Medical Officer
Srikant T. Madhav Datar Independent Non-Executive Director
Sector and Competitors
1st jan.Capitalization (M$)
NOVARTIS15.60%198 194
JOHNSON & JOHNSON1.05%343 382
ROCHE HOLDING LTD.16.27%243 639
PFIZER-16.36%201 939
NOVO NORDISK AS17.30%122 365