Over 50 million secondary prevention patients worldwide with atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia (FH) on current standard of care do not achieve LDL cholesterol (LDL-C) goal and remain at increased risk of cardiovascular events1
The Medicines Company submitted the New Drug Application (NDA) for inclisiran to the FDA in December 2019
Comprehensive Phase III inclisiran program showed potent and durable reduction of >50% in LDL-C on top of standard of care, with excellent safety profile2,3,4
Adds potentially soon-to-launch, first-in-class investigational product, leveraging significant synergies with existing global cardiovascular commercial capabilities
Basel, January 6, 2020 — Novartis AG (NYSE: NVS) (“Novartis”) today announced that it has completed the acquisition of The Medicines Company (the “Company”) through the consummation of a merger of its indirect wholly-owned subsidiary, Medusa Merger Corporation (“Purchaser”), with and into the Company, with the Company surviving the merger, without a vote of the Company’s stockholders in accordance with Section 251(h) of the Delaware General Corporation Law. In the merger, each share of the Company’s common stock outstanding immediately prior to the effective time of the merger (other than shares owned by Novartis, Purchaser, the Company, any other subsidiary of Novartis or any subsidiary of the Company, or shares that are held in the Company’s treasury or shares held by any Company stockholder who has properly demanded and perfected appraisal rights under Delaware law) has been converted into the right to receive USD 85.00 per share, net to the seller in cash, without interest and subject to any tax withholding. As a result of the merger, the Company became an indirect wholly-owned subsidiary of Novartis and the Company’s shares have ceased to be traded on the NASDAQ Global Select Market.
Vas Narasimhan, CEO of Novartis, said: “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. It’s a significant step forward on our journey to focus the company, to reimagine medicine, and to bend the curve of life.”
Marie-France Tschudin, CEO, Novartis Pharmaceuticals said: “I’m looking forward to welcoming associates from The Medicines Company to Novartis. There is a real unmet need for patients living with atherosclerotic cardiovascular disease or familial hypercholesterolemia on current standard of care, who are not achieving LDL cholesterol goals and remain at significant risk of cardiovascular events. With a unique twice yearly, subcutaneous dosing regimen which integrates seamlessly with routine HCP visits, inclisiran has the potential to improve adherence and, potentially, patient outcomes for the millions of people living with ASCVD or FH.”
In December 2019, The Medicines Company submitted the New Drug Application (NDA) for inclisiran to the FDA for use in secondary prevention patients with atherosclerotic cardiovascular disease (ASCVD) and familial hypercholesterolemia (FH).
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References
1. Novartis. Data on file
2. Raal FJ et al. Safety and Efficacy of Inclisiran in Patients With Heterozygous Familial Hypercholesterolemia. Data presented at: AHA Scientific Sessions 2019, Nov 16-18; Philadelphia, USA.
3. Wright RS et al. Inclisiran for subjects with ASCVD and elevated low-density lipoprotein cholesterol. Data presented at: AHA Scientific Sessions 2019, Nov 16-18; Philadelphia, USA
4. Ray K et al. Impact of inclisiran on LDL-C over 18 months in patients with ASCVD or risk-equivalent. Data presented at: European Society of Cardiology Congress, Aug 29 – Sept 2; Paris, France
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