Novartis shares fall in Zurich as cardiovascular drug fails final trial
The late-stage trial of pelacarsen did not meet its primary endpoint, which was to reduce the risk of cardiovascular events compared with placebo
(Il Sole 24 Ore Radiocor) – A second clinical setback in the space of a week for Novartis: after suspending trials of an experimental cell therapy for autoimmune diseases following the deaths of three patients, the pharmaceutical company has announced that an experimental drug failed to reduce cardiovascular risk in a clinical trial in the final stage of testing. Consequently, in Zurich, the share price fell by 2.4 per cent, marking its sharpest decline in the last four months, whilst since the start of the year the share had gained 14 per cent.
Specifically, the company stated that the late-stage trial of the drug pelacarsen had not met its primary endpoint, which was to reduce the risk of cardiovascular events — such as deaths, heart attacks and strokes — compared with placebo. The drug did indeed reduce blood levels of a cholesterol-carrying particle known as lipoprotein, but this did not, as expected, result in a reduction in cardiovascular risk, Novartis explained.
“These are not the results we had hoped for, but they provide important evidence that enhances the scientific understanding of the relationship between Lp(a) reduction and cardiovascular outcomes and could help guide future approaches to cardiovascular risk management,” said Shreeram Aradhye, Chief Medical Officer at Novartis. The failure represents a significant setback for hopes that the drug might usher in a new approach to the prevention of cardiovascular disease.
“This calls into question the possibility that any therapy capable of reducing Lp(a) might ultimately demonstrate a cardiovascular benefit,” the experts at Jefferies point out. Analysts regarded pelacarsen as a potential blockbuster, with peak sales estimates ranging from around $1.5 billion according to UBS to $5.4 billion according to Jefferies, although the investment bank attributed only a 30 per cent probability of success to the drug. Novartis had estimated that the overall market opportunity exceeded $5 billion.
The next major test for the pipeline will be an experimental injectable treatment designed to target the genetic cause of DM1 (myotonic dystrophy type 1), a condition that causes progressive muscle wasting, rather than merely treating its symptoms. In this regard, sources within the company point out that the treatment, del-desiran, is also at the heart of Novartis’s $12 billion acquisition of Avidity.
