Novartis to acquire The Medicines Co., maker of cholesterol-lowering drug, for $9.7B

The deal will give the Swiss drugmaker control of inclisiran, a drug for which The Medicines Company plans to file for approval in lipid disorders starting this quarter.

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One of the world’s largest drugmakers will acquire a firm developing a drug for cholesterol for nearly $10 billion.

Basel, Switzerland-based Novartis said Sunday it would acquire Parsippany, New Jersey-based The Medicines Company for $9.7 billion, or $85 per share. Shares of The Medicines Company opened 22.5 percent higher on the Nasdaq Monday morning following the news.

The Medicines Company’s lead product candidate is inclisiran, which it is developing under a partnership with Cambridge, Massachusetts-based Alnylam Pharmaceuticals. The drug is an RNA-interference agent designed to prevent production of PCSK9, which is the molecular target of two approved drugs made by Amgen and a partnership between Sanofi and Regeneron Pharmaceuticals. Amgen’s drug is Repatha (evolocumab), while Sanofi and Regeneron’s is Praluent (alirocumab). Inclisiran is administered twice per year, whereas Repatha and Praluent are administered once every two to four weeks.

“With tens of millions of patients at higher risk of cardiovascular events from high LDL-C, we believe that inclisiran could contribute significantly to improved patient outcomes and help healthcare systems address the leading global cause of death,” Novartis CEO Vas Narasimhan said in a statement. “The prospect of bringing inclisiran to patients also fits with our overall strategy to transform Novartis into a focused medicines company and adds an investigational therapy with the potential to be a significant driver of Novartis’ growth in the medium to long term.”

Two weeks ago, 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.

The company said that it expects to file for Food and Drug Administration approval during the fourth quarter of this year, followed by European filings in Europe in the first quarter of 2020.

In a note to investors Monday, B. Riley FBR analyst Mayank Mamtani wrote that inclisiran’s reduced cost, medication burden and logistics are particularly attractive in the context of the primary care setting, which accounts for around 70 percent of patients with high cholesterol and 95 percent of prescriptions for lipid-lowering drugs. Mamtani pointed to several factors driving that attractiveness. In particular its overall pricing comes in below that of antibodies and is competitive with oral drugs, It is available as a pre-filled syringe and doesn’t require refrigeration, which would enable long-term storage in the clinic or even at home, enabling healthcare providers to offer in-home administration enabled by technology platforms like Uber and Google. And the buy-and-bill mechanism comes into play, with providers motivated to participate in patient care and patients not bogged down with out-of-pocket co-pays.

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