Novartis Pelacarsen Miss Rattles Lp(a) Drug Race — SkimNews
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- Novartis reported that pelacarsen — developed jointly with Ionis Pharmaceuticals — reduced Lp(a) cholesterol in a late-stage cardiovascular trial but failed to significantly reduce heart attacks and strokes; Novartis stock fell 3% on Monday.
- Amgen shares dropped about 5% and Ionis Pharmaceuticals sank 10% in extended trading Friday, as Citi analysts said the first dedicated outcomes failure in the Lp(a) drug race "lowers confidence across the class."
- NewAmsterdam Pharma, a Netherlands-based competitor also developing an Lp(a)-lowering treatment, saw its U.S.-listed shares fall 12% in extended trading Friday.
- Amgen's olpasiran faces the clearest readthrough, while Eli Lilly's lepodisiran is being tested on a broader patient population — including some without established cardiovascular disease — limiting direct comparison, Citi analysts said.
- Analysts had modeled peak annual sales of $4 billion to $5 billion for pelacarsen, which would have cushioned Novartis as it faces what CEO Vas Narasimhan called "the steepest patent cliff in its history."
- Lp(a) — discovered in 1963, genetically determined, and unresponsive to diet or exercise — elevates cardiovascular risks for roughly one in five people worldwide, and there is currently no approved targeted treatment.
- Citi analysts said "the Lp(a) hypothesis is weakened, but not disproven," noting the miss could reflect pelacarsen's mechanism, trial design, or a broader challenge to the hypothesis that lowering Lp(a) reduces cardiovascular events.
Why it matters: Novartis had counted on pelacarsen for $4-5 billion in peak annual sales to offset the looming loss of Entresto's patent exclusivity. With no approved Lp(a) treatment existing for the roughly one-in-five people worldwide with elevated levels, rival drugs from Amgen and Eli Lilly now face heightened pressure to prove that deeper cholesterol reductions translate into fewer heart attacks and strokes.
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