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Novartis Builds Cardiovascular Drug Pipeline with The Medicines Company Acquisition

Novartis Builds Cardiovascular Drug Pipeline with The Medicines Company Acquisition

  • Posted by ISPE Boston
  • On December 5, 2019

Novartis announced today that it has entered into an agreement to acquire The Medicines Company for USD 85.00 per share in cash, valuing the company at approximately USD 9.7 billion on a fully diluted equity basis. The transaction has been unanimously approved by the Boards of Directors of both companies and is expected to close in the first quarter of 2020, subject to the satisfaction or waiver of all closing conditions.

The planned acquisition of The Medicines Company would add inclisiran, a potentially first-in-class siRNA inhibitor targeting PCSK9,  and would allow Novartis to continue building pipeline depth in a key therapeutic area – a central pillar of its M&A strategy. Inclisiran has the potential to fundamentally change the treatment of elevated low-density lipoprotein cholesterol (also known as LDL-C) in high risk patients and is thus aligned with the Novartis strategic priority of delivering truly transformational medicines for patients.

Additionally, with The Medicines Company expecting to file regulatory submissions in the U.S. in the fourth quarter of 2019 and in Europe in the first quarter of 2020, inclisiran represents a near-term product launch opportunity and is expected to contribute to sales from 2021. Furthermore, broadening the cardiovascular portfolio would enable Novartis to leverage its core commercial capabilities including its strong cardiovascular field force both in the US and globally. Finally, the transaction is consistent with Novartis’ capital allocation priorities to invest in transformative innovation and long term value creation for shareholders.

Inclisiran, potentially the first and only cholesterol-lowering therapy in the siRNA (small-interfering RNA) class, is The Medicines Company’s investigational twice-yearly therapy in Phase III clinical development to evaluate its ability to reduce LDL-C. As a siRNA, inclisiran harnesses the body’s natural process of RNA interference to specifically prevent 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.

Inclisiran is not yet approved by the FDA or any other regulatory authority. The Medicines Company obtained global rights to develop, manufacture and commercialize inclisiran under a license and collaboration agreement with Alnylam Pharmaceuticals. On January 23, 2018, the FDA granted orphan drug designation to inclisiran for the treatment of homozygous familial hypercholesterolemia. (Source: Novartis Website, 24 November, 2019)

 

 

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