It’s less than a week before the J.P. Morgan Healthcare Conference begins in San Francisco, and one large pharmaceutical company is kicking off the year with the announcement that it has completed its deal to buy a company developing an RNA-targeting drug for cholesterol.
Novartis said Monday that it had completed its $9.7 billion acquisition of Parsippany, New Jersey-based The Medicines Company, which that company and the Basel, Switzerland-based drugmaker had announced in November.
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The Medicines Company’s lead product candidate is inclisiran, an RNA-interference (RNAi) drug for atherosclerotic cardiovascular disease and familial hypercholesterolemia. The drug was submitted for regulatory approval to the Food and Drug Administration for both diseases in December.
The drug, which is being developed under a partnership with Cambridge, Massachusetts-based Alnylam Pharmaceuticals, works by blocking production of the protein PCSK9, which is involved with production of LDL cholesterol. Currently, there are two anti-PCSK9 drugs on the market, namely Amgen’s Repatha (evolucumab) and Sanofi’s Praluent (alirocumab). But in contrast to inclisiran, they work by targeting PCSK9 directly and must be administered every two to four weeks, while inclisiran is designed to be given only twice per year.
“Acquiring The Medicines Company and inclisiran gives Novartis a unique opportunity to open up a new chapter on the treatment of the world’s leading cause of mortality and disability with a vaccine-like approach,” Novartis CEO Vas Narasimhan said in a statement.
Alnylam President Barry Greene has previously noted that the combined market cap for companies with RNA-targeting drugs is more than $55 billion.
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Last year, The Medicines Company presented data at the American Heart Association’s annual meeting from the Phase III ORION-9 and ORION-10 studies of inclisiran, respectively testing the drug in patients with heterozygous familial hypercholesterolemia (HeFH) and atherosclerotic cardiovascular disease (ASCVD). In ORION-9, inclisiran achieved 50 percent lowering of LDL cholesterol with time-adjusted reductions of 45 percent over 18 months. In ORION-10, it showed a 58 percent lowering, with time-adjusted reductions of 56 percent sustained over 18 months of treatment. Both studies compared the drug against placebo.
RNAi drugs represent a growing field with two therapies currently on the market, both made by Alnylam. One is Onpattro (patisiran), which is approved for treating polyneuropathy in patients with hereditary transthyretin-mediated amyloidosis, a rare and fatal disease. The other is Givlaari (givosiran), approved for acute hepatic porphyria, a liver enzyme deficiency disease.
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