US biotechnology company, Scios – a unit of Johnson & Johnson - is to cut back its workforce on declining sales of the heart drug Natrecor, which tumbled from grace after safety concerns were raised last year and amid an investigation into the firm’s alleged promotion of off-label uses.
According to a report in the New York Times, the firm’s workforce will be trimmed by 150 from a total of 900 jobs and will primarily affect those in sales and marketing functions.
Once a $400 million drug, and widely tipped to become a blockbuster, revenues dipped dramatically after questions were raised in the Journal of the American Medical Association (April 20, 2005) about Natrecor’s effect on the kidneys and link to fatalities: a meta-analysis of three clinical studies suggested that Natrecor was linked to a higher rate of death than standard therapy after 30 days’ treatment.
The news triggered a label change to include the mortality data and, in June 2005, a panel recommended Natrecor’s use should be limited to only the sickest patients while J&J conducted a large-scale study to prove the drug is safe.
But this is not going according to plan and Scios has since found two additional deaths in a clinical trial re-analysis: the original results showed five cases of death among patients on Natrecor, but concluded that there was no difference between the active drug and placebo in mortality. J&J said it was now investigating why the two additional deaths were not reported, and if they change the conclusions of the trial.
Johnson & Johnson paid $2.4 billion dollars for Scios in 2003, after Natrecor was approved two years earlier for the treatment of acutely decompensated heart failure. Scios was subpoenaed in July 2005 by the attorney's office in Boston requesting documents relating to the sales and marketing of Natrecor amid allegations that the unit had promoted Natrecor for off-label use in patients with less severe heart failure.