Novartis heart medicine fails in final stage of trial, failure deepens setbacks

Novartis AG experienced a second trial setback within a week, as the Swiss pharmaceutical company's promising heart medication failed in a final-stage trial.

A Bloomberg report said the drug, pelacarsen, did succeed in reducing levels of lipoprotein(a), a primarily genetic risk factor for cardiovascular disease that impacts approximately one in five individuals. However, this reduction did not result in a decrease in deaths, heart attacks, or strokes when compared to a placebo, as reported by the Swiss drug manufacturer late Friday.

This failure represents a significant blow to the expectations that the medication would introduce a novel method for preventing cardiovascular disease. It also follows closely on the heels of Novartis's decision to temporarily halt trials of an experimental cell therapy for autoimmune diseases after the deaths of three patients.

In early trading in Zurich, Novartis shares dropped by as much as 3.9%, marking the largest decline in over four months. Despite this, the shares have risen by 14% so far this year. Meanwhile, shares of Amgen Inc., which is working on a similar heart medication, fell nearly 7% in post-market trading on Friday.

Novartis is relying on a series of new medications to maintain growth as some of its major products approach the end of their patent protection. Chief Executive Officer Vas Narasimhan has indicated that successful late-stage trials could enable the company to increase its forecast for annual sales growth from 5% to 6% through 2030.

The next significant test in the pipeline is an experimental injection aimed at addressing the genetic cause of DM1, a muscle-wasting condition, rather than merely alleviating its symptoms. This treatment, del-desiran, is also central to Novartis's $12 billion acquisition of Avidity.

These two setbacks hold implications that extend beyond the individual drugs. Novartis had positioned both pelacarsen and rapcabtagene autoleucel, or rap-cel, as potential game-changers in their respective areas: one by addressing a previously untreatable inherited cardiovascular risk and the other by introducing CAR-T cell therapy into the realm of autoimmune diseases.

The report further added that the disappointment regarding pelacarsen comes after a week of mixed results for Novartis, during which one of its experimental therapies did fulfil expectations, offering some relief. The company’s remibrutinib, a pill for multiple sclerosis, achieved success in two late-stage trials, resulting in a share price increase of over 6% on Tuesday.

Novartis provided limited information about the failure of pelacarsen, including how close it was to achieving the trial objectives or if certain patients experienced greater benefits than others. The company indicated that comprehensive results will be shared at an upcoming medical conference.

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