A few days ago, Novartis quietly disclosed in its first_quarter 2021 financial report that the Phase 3 clinical trial Paradise-MI showed that Entresto missed the primary endpoint of reducing the risk of cardiovascular death and heart failure after acute myocardial infarction.
In this study, the data trend of the trial results has been leaning towards the standard treatment drug ramipril (ramipril), Entresto has not reached its goal.
Novartis initiated the Paradise-MI clinical study in 2016 to see if Entresto can surpass the widely used ACE inhibitor ramipril in reducing cardiovascular death and heart failure in patients with heart attacks. This study enrolled 5669 subjects and studied Entresto at a dose of 200 mg and ramiprilat at a dose of 5 mg. In addition to receiving standard post-heart attack treatment, both drugs are taken twice a day.
Although the results of the study were not satisfactory, in terms of sales, Entresto's sales in the first quarter increased by 39% to $789 million, helping Novartis to offset the problem of sales decline caused by competition in the generic drug business.
Entresto's trial failure occurred shortly after a major victory for the drug's heart failure indication. The US FDA approved Entresto in February for the treatment of patients with heart failure whose left ventricular ejection fraction (LVEF) is lower than normal and preserved ejection fraction (HFpEF).
In addition to Entresto's existing studies on patients with chronic heart failure and reduced ejection fraction, the approval also positions the drug as the first and only drug approved in both cases. According to Novartis, this new indication label also paves the way for Novartis to target about 5 million of the 6 million Americans with chronic heart failure using the drug.
Peter Welford, an analyst at Jefferies, a well-known Wall Street investment bank, wrote in 2020 when an independent team of the US FDA supported the use of the drug in patients with HFpEF, that Entresto's top sales are expected to increase by another $1 billion. As for the failed trials, Welford pointed out that the patient market after a heart attack only accounts for $525 million of the estimated $5.1 billion of Entresto's global peak sales. According to reports, Entresto will have sales of US$2.5 billion in 2020 and will become Novartis’s third_largest source of revenue in 2020.
In addition, Novartis’s financial report for the first quarter of 2021 showed that net sales fell by 2% to US$12.411 billion, which was related to long-term purchases related to COVID-19 in the previous year (about US$400 million). Sales of the pharmaceutical business unit remained the same as the previous year, at 10.1 billion US dollars, of which Entresto (+34%cc), Zolgensma (+81%cc), and Cosentyx (+11%cc) continued to grow strongly; Kesimpta sales reached 5000 Ten thousand U.S. dollars. Driven by Kymriah (+55%cc), Promacta/Revolade (+13%cc), Kisqali (+19%cc), and Jakavi (+8%cc), sales of the Oncology Division increased by +1%, Adakveo Sales reached 37 million U.S. dollars. The generic drug business unit Sandoz (Sandoz) sales fell by -13% to $2.3 billion, retail sales fell by -18%, and biopharmaceutical business sales increased by +7%. COVID-19 has harmed sales, especially in dermatology, ophthalmology, breast cancer portfolio, Sandoz retail business, and anti-infectives.
Reference source:
1. Novartis earnings report
2.Amid impressive growth, Novartis" blockbuster Entresto falls short in post-heart attack trial
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