Novartis has added potential blockbuster cholesterol treatment inclisiran to its pipeline following the completion of its $9.7bn acquisition of The Medicines Company.
When Novartis first announced its intention to acquire MedCo, it highlighted inclisiran as the main attraction of the deal, and has reiterated the importance of the drug now that it has successfully completed the takeover.
In a statement, Novartis said that the acquisition of MedCo and inclisiran “adds a potentially soon-to-launch, first-in-class investigational product, leveraging significant synergies with existing global cardiovascular commercial capabilities”.
MedCo’s inclisiran is a small, interfering RNA (siRNA) drug which works by blocking the synthesis of PCSK9 in the liver rather than targeting the protein itself.
This allows more receptors on the liver cell surface to capture LDL cholesterol to break down. By lowering LDL levels – so-called ‘bad’ cholesterol – the likelihood of major cardiac events decreases.
Its mechanism means it can be administered as a subcutaneous injection initially, and then again at three months and every six months thereafter.
This dosing schedule means that MedCo’s drug could pose a major challenge to established drugs in the class, including Amgen’s Repatha (evolocumab) and Sanofi/Regeneron’s Praluent (alirocumab).
Repatha and Praluent are dosed more frequently – either monthly or bi-monthly. Both drugs have struggled to grow, mainly due to payer resistance, with their respective developers offering discounts from $14,000 per year at launch to around $6,000.
Analysts have suggested that Novartis is likely to price inclisiran at a discount to its rivals at launch to help it make headway in the market.
The drug also fits nicely into Novartis’ cardiovascular portfolio alongside Entresto (sacubitril/valsartan), its heart failure medication which has grown since its launch to bring in at least $1.2bn last year.
The planned approval for inclisiran is set to be completed in the first quarter of this year, with Novartis expecting the drug to begin to contribute to group sales from 2021.
“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,” said Vas Narasimhan, CEO of Novartis.
“It’s a significant step forward on our journey to focus the company, to reimagine medicine, and to bend the curve of life,” he added.