Comments from The Medicines Company

Here is what Mark Timney, Chief Executive Officer of The Medicines Company said about the transaction.“Our company’s singular, relentless focus and the unwavering commitment of our employees have led to this opportunity to unlock the intrinsic value of inclisiran for patients and to maximize value for our shareholders. We are excited that millions of patients with atherosclerotic cardiovascular disease and familial hypercholesterolemia will potentially benefit from this transformational therapy.”

Alexander J. Denner, Ph.D., Chairman of The Medicines Company Board of Directors, said: “This $9.7 billion transaction is a great outcome for shareholders of The Medicines Company. Not so long ago, The Medicines Company was at a crossroads due to the loss of its key revenue driver. I am proud of the company’s transformation under a reconstituted board into a lean, highly focused team successfully advancing an exciting new therapy and creating tremendous value for patients and shareholders.” 

Dr. Denner continued, “Our vision for inclisiran is an affordable, widely available treatment that will dramatically reduce both the medical and economic burden of cardiovascular disease. Given the enormous capital required to realize its full potential, we have decided to sell to a company with resources and scale in excess of ours.”

When Is the Transaction Expected

The transaction is expected in the first quarter of 2020 pending the successful completion of the tender offer and other customary closing conditions. Until that time, The Medicines Company will continue to operate as a separate and independent company. The company expects to file regulatory submissions for inclisiran in the U.S. in the fourth quarter of 2019 and in Europe in the first quarter of 2020.

The Medicines Company obtained global rights to develop, manufacture and commercialize inclisiran under a license and collaboration agreement with Alnylam Pharmaceuticals (ALNY).

Prohost Observations  

Novartis is immersed in treating genetic-derived diseases and has already a gene therapy product, Zolgensma, approved and marketed for spinal muscular atrophy (SMA). There was no doubt that the successful results of the RNAi product, in lowering the bad cholesterol and the risk of cardiovascular disease, would attract Novartis’ attention. Inclisiran is the first and only cholesterol-lowering therapy in the siRNA (small-interfering RNA) class. It harnesses the body’s natural process of RNA interference to specifically prevent the production of the PCSK9 protein in the liver which enhances the liver’s ability to remove LDL-C from the bloodstream thereby lowering LDL-C levels.

In Phase 3 studies, inclisiran reduced LDL-C up to 58% and sustained durable time-adjusted LDL-C reductions of up to 56% throughout a twice-yearly dosing schedule when administered along with statins and/or ezetimibe. Inclisiran is not yet approved by the FDA or any other regulatory authority.  

We congratulate The Medicines Company, Alnylam, the creator of inclisiran, and The Medicines Company’s shareholders.  

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