Novartis cancels study of heart drug pelacarsen

Novartis is developing a drug with the active ingredient pelacarsen that is intended to reduce the risk of heart attacks and strokes. After years of research, the pharmaceutical company is now canceling the study - the shares are also coming under pressure.

A setback in the development of a new heart drug is weighing on Novartis shares. The Swiss pharmaceutical company's shares fell by 3.3 percent in early trading. Novartis announced on Friday evening that the drug pelacarsen was unable to reduce the risk of serious heart attacks and strokes as hoped in a crucial clinical trial. Analysts had expected Pelacarsen to have annual sales of between three and six billion dollars at its peak.

The drug, developed together with US partner Ionis Pharmaceuticals, is intended to lower a genetically determined form of cholesterol, the so-called lipoprotein(a). Around 20 percent of the world's population carries this hereditary cardiovascular risk, which can hardly be influenced by diet or lifestyle. In the six-year study with over 8,000 patients, the monthly injection reduced lipoprotein(a) levels, but did not prevent serious events such as heart attacks, strokes or cardiovascular-related deaths.

“These are not the results we were hoping for,” Novartis chief medical officer Shreeram Aradhye said. However, the data provided important insights into the connection between lowering lipoprotein(a) and the effects on the cardiovascular system. After the announcement, Ionis shares fell by twelve percent in after-hours US trading on Friday.

Setback in the expansion of the medication division

The JPMorgan analysts pointed out that the patients in the study were already very well medically adjusted. Modern cholesterol-lowering drugs and weight-loss drugs have made it increasingly difficult for new active ingredients to demonstrate additional benefit in clinical trials. For Novartis, the failure is a setback in efforts to refresh its drug pipeline. The group has to cope with the expiration of patents for important revenue generators such as the heart drug Entresto.

The disappointment is partly offset by the recent success of the multiple sclerosis drug remibrutinib, which was convincing in a late phase of studies last week. In addition to remibrutinib, investors' hopes are now focused on the gene therapy del-desiran against muscular dystrophy. Novartis spent $12 billion last year to secure the drug through a takeover.

The setback with pelacarsen also put competitors under pressure: the shares of the US biotech company Amgen, which, like Eli Lilly, is working on a similar active ingredient, also fell around five percent after trading on Friday. Novartis and Ionis plan to present the full study data on pelacarsen at an upcoming medical conference.