Merck bets $200M on a new type of heart pill

Dive Brief:

• Merck & Co. has entered a competitive race for a new type of heart drug, announcing Tuesday it will pay China-based Jiangsu Hengrui Pharmaceuticals $200 million upfront to license a pill that blocks a protein particle believed to contribute to blood vessel blockages.
• Per deal terms, Merck will receive rights outside of the greater China region to the therapy, dubbed HRS-5346 and is currently in Phase 2 testing. Jiangsu Hengrui could receive another $1.77 billion in additional payments, as well as sales royalties, if the drug hits certain development, regulatory and commercial milestones.  
• Jiangsu Hengrui’s pill is one of many experimental LpA-blocking drugs in clinical development. The furthest along is an RNA-based medicine from Novartis that’s currently in Phase 3 testing. Cardiovascular outcomes data are expected in 2026 and considered an important indicator of how strongly these drugs impact heart health.

Dive Insight:

Merck was one of the pioneers of the cholesterol-lowering statins that launched in the 1980s and 1990s and changed medical practice. But it hasn’t been as successful with cholesterol medicines since then, with cancer immunotherapy, not heart disease, now its main revenue driver. 

Still, Merck has shown an interest in making heart medicines a bigger part of its future. A drug it acquired in a buyout of Acceleron Pharma is now approved for pulmonary arterial hypertension and expected to become a future blockbuster. An oral medication aimed at PCSK9, a target of marketed injectable medicines, is currently in Phase 3 testing. And with Tuesday’s deal, the company has bought into the potential of drugs that block Lp(a). 

The alliance gives the company “an important addition that expands and complements our cardio-metabolic pipeline,” said Dean Li, president of Merck Research Laboratories, in a statement.

The frontrunners in the chase, among them Novartis and Amgen, are using oligonucleotide therapies to stop production of Lp(a). But oral alternatives are advancing, too. A Lilly drug called muvalaplin has completed Phase 2 trials, while AstraZeneca paid China-based biotech CSPC Pharmaceutical $100 million for an Lp(a)-blocking drug in preclinical testing. 

The deal “suggests the industry is moving towards orals,” wrote Jefferies analyst Dennis Ding, in a Tuesday note to clients.

The drug Merck has licensed is currently in a Phase 2 trial in Beijing. Jiangsu Hengrui has been recruiting volunteers with heart disease or at high risk of developing it, and is testing three doses against a placebo to see how well the drug lowers Lp(a) levels over 12 weeks. That trial is expected to conclude by the end of the year.

Early data from the injectable RNA therapies have set a high bar for Merck to clear, stimulating greater than 90% reduction of Lp(a) in clinical testing, Jefferies analyst Ding wrote. Lilly’s muvalaplin has done almost as well, with up to an 85% reduction. 

Still, Ding noted that effective oral medicines might compete with injectables in the 10% to 15% of people with very high levels of Lp(a). They could also capture the “vast majority” of people with Lp(a) levels that aren’t high enough to qualify for injectable therapies, he added. 

“Regardless, the Lp(a) market is very large and we consider this as pharma white space given [there are] no approved therapies,” Ding wrote.

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