MSD licenses Lp(a) heart drug from Hengrui in $2bn deal
Dr Dean Li, president of Merck Research Laboratories
MSD has fleshed out its cardiovascular disease pipeline by licensing an oral Lp(a) inhibitor from China's Jiangsu Hengrui Pharma for $200 million upfront.
The deal gives MSD exclusive rights to the HRS-5346 candidate outside the Greater China region and also includes milestone payments tied to development, regulatory, and commercial targets that could be worth up to $1.77 billion.
MSD – known as Merck & Co in the US and Canada – said that HRS-5346 is currently in a phase 2 trial in China. It expects the licensing deal to complete in the second quarter of the year.
The candidate offers an oral alternative to other drugs in the pharma industry pipeline that are targeting Lp(a), including Novartis/Ionis' pelacarsen in phase 3 – dosed by subcutaneous injection once per month – and Amgen's olpasiran which is injected every three months and also in late-stage clinical testing. Both are antisense-based therapeutics.
Eli Lilly meanwhile has an RNA interference drug lepodisiran that could be dosed once a year is in phase 3, as well as a daily oral candidate called muvalaplin in phase 2, while Silence Therapeutics' RNAi-based zerlasiran is in a mid-stage trial and has been shown to inhibit Lp(a) for five months with a single dose.
Novartis has also tapped Ionis for a follow-up Lp(a) candidate that so far remains largely under wraps, and has said that it expects pelacarsen to have multibillion-dollar peak sales potential.
Elevated Lp(a) is recognised as an independent genetic risk factor for coronary artery disease, heart attack, stroke, peripheral arterial disease, and aortic stenosis. Currently, there are no approved drugs to reduce levels of the lipoprotein.
It is estimated that about 50% of atherosclerotic cardiovascular disease is not driven by LDL-cholesterol – the target of most lipid-lowering drugs, including statins and PCSK9 inhibitors – and that the majority of those cases are associated with Lp(a).
"Elevated blood concentrations of Lp(a) provides a well-documented risk factor for atherosclerotic cardiovascular disease, affecting as many as one in five adults globally," said Dr Dean Li, president of Merck Research Laboratories.
"HRS-5346, an investigational oral small molecule inhibitor of Lp(a) formation, is an important addition that expands and complements our cardio-metabolic pipeline," he added.
