Novartis announces intent to collaborate with NHS England to tackle burden of cardiovascular disease in the UK

• Novartis aims to bring first-in-class cholesterol lowering drug via a world-first, population health model to large at risk NHS patient population with atherosclerotic cardiovascular disease (ASCVD)

• Inclisiran is an investigational cholesterol-lowering treatment, currently in Phase III clinical development and expected to be filed for regulatory approval in Q1 2020

• The collaboration encompasses three proposals: a primary prevention clinical trial, a population health access model for high risk ASCVD patients (upon marketing authorisation and NICE approval) and a proposal to look at manufacturing synergies that could improve oligonucleotide manufacturing scale and efficiency

• The programme is part of the Novartis commitment to collaborate and their belief that the future of life sciences lies in different organisations working together

London, UK. 18:00 GMT, 13 January 2020 – Novartis today announced its intent to collaborate with NHS England focused on addressing cardiovascular disease (CVD); a significant cause of disability and death in the UK1.

The current proposal is to create a pioneering collaboration that brings together three projects that aim to tackle – directly or indirectly – the healthcare challenge of CVD, whilst also providing increased opportunities for UK life science sector development. The current Memorandums of Understanding (MOUs), which form the basis of the collaboration, were negotiated and signed by The Medicines Company prior to its acquisition by Novartis.

The investigational drug inclisiran is currently in Phase III development for secondary prevention patients with expected European Medicines Agency (EMA) regulatory filing in Q1 2020. The first proposal, upon regulatory approval and the National Institute for Health and Care Excellence (NICE) assessment, would be to provide inclisiran to secondary prevention ASCVD patients through a population-level agreement. Providing inclisiran to this high-risk population could make a significant contribution towards meeting the NHS long-term commitment2 to preventing 150,000 cardiovascular deaths over 10 years.

The second proposal is to explore a large-scale clinical trial to evaluate the use of inclisiran to patients at very high risk of having their first cardiac event (primary prevention).

The final proposal includes the creation of an industry and academic consortium to look at manufacturing synergies that could improve the efficiency and scale at which the UK can manufacture oligonucleotide medicines, such as inclisiran.

“Novartis has a unique opportunity with inclisiran to open up a new chapter in the treatment of cardiovascular disease, the world’s leading cause of mortality and disability.  

We’re confident that innovative approaches like this will enable us to accelerate access timelines, deliver on our broader commitment to generating leading scientific evidence, and ensure continuous improvement in manufacturing efficiency and optimization.” said Vas Narasimhan, Chief Executive Officer of Novartis.

Cardiovascular disease is responsible for around 64,000 deaths in the UK each year3. The NHS Long Term Plan identified cardiovascular disease as a clinical priority and the single biggest condition where lives can be saved by the NHS over the next 10 years.