Novartis is acquiring New Jersey-based biopharma, The Medicines Company, in a $9.7 billion deal that adds a “potentially transformational” investigation cholesterol-lowering therapy to its pipeline.
“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,” said Novartis CEO Vas Narasimhan.
“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.”
The Medicines Company recently announced data from its comprehensive clinical program consisting of three Phase III trials (ORION-9, 10 and 11) for inclisiran involving over 3,600 high-risk patients with ASCVD and FH. In all trials, inclisiran demonstrated potent and durable LDL-C reduction with an excellent safety and tolerability profile.
Furthermore, inclisiran’s potentially first-in-class, twice-yearly dosing schedule allows administration during patients’ routine visits to their healthcare professionals and will likely contribute to improved patient adherence and sustained, lower LDL-C levels.
The Medicines Company expects to file regulatory submissions in the US in the fourth quarter of 2019 and in Europe in the first quarter of 2020.
An ongoing clinical trial (ORION-4) will evaluate the cardiovascular morbidity and mortality benefits of inclisiran.
The transaction is expected to close in the first quarter of 2020, subject to the satisfaction or waiver of all closing conditions.
Until closing, Novartis and The Medicines Company will continue to operate as separate and independent companies.