Novartis Enters RNA Therapeutics with Medicines Company Merger

Luxturna gene therapy blindness Europe

Novartis is to acquire The Medicines Company and its late-stage RNA interference drug designed to protect against cardiovascular disease in twice-yearly shots.

Novartis will pay €8.8B ($9.7B) to acquire The Medicines Company, which is based in the US and focuses on developing the RNA drug inclisiran for the treatment of cardiovascular disease and renal impairment. The drug has met the primary endpoint in three phase III trials for the treatment of cardiovascular disease, and The Medicines Company expects to apply for market approval in the US later this year, and in the EU in early 2020. 

Statins are currently the gold standard for reducing the levels of blood cholesterol in people at risk of cardiovascular disease. However, some patients aren’t able to use high doses of statins because the drugs cause too many side-effects such as muscle aches and headaches. 

Inclisiran is an RNA drug that blocks the production of a protein called PCSK9 in a process called RNA interference, or RNAi. Blocking the production of this protein protects against cardiovascular disease because the protein increases the blood levels of low-density lipoprotein cholesterol, an unhealthy form of cholesterol that increases the risk of cardiovascular disease. 

Inclisiran works in a different way to existing PCSK9-blocking drugs on the market such as Praluent. While other drugs block the protein after it is made in the cell, inclisiran stops cells from making the protein in the first place in a longer-lasting process. A big selling point for patients is that, while other drugs require injections up to once a month, inclisiran is designed to be injected just twice per year. 

Inclisiran was originally developed by US company Alnylam Pharmaceuticals, from whom The Medicines Company licensed the drug. According to Novartis, inclisiran could become one of its best-selling products if approved because of its long-lasting effects and the huge cardiovascular disease market. 

After decades of research, the first RNAi therapies have begun to arrive on the market. The first RNAi therapy to get market approval was Alnylam’s Onpattro last year for the treatment of an incurable rare neurological disease. Just last week, Alnylam followed up with the FDA approval of another RNAi therapy; Gilvaari, for the treatment of a rare genetic liver condition. Novartis’ takeover of The Medicines Company is the first acquisition of a company developing an RNAi drug, taking place only a year after the first RNAi drug approval.

Companies in Europe also working on RNAi technology include the UK biotech Silence Therapeutics and Spanish company Sylentis.

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