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.
Atherosclerotic cardiovascular disease (ASCVD) is a leading cause of death worldwide. ASCVD results from a thickening and loss of elasticity in the arterial wall. It is a severe disorder and the leading cause of morbidity (sickness) and mortality (death) in most developed countries. High levels of LDL cholesterol build up on the walls of blood vessels. This build up is called “plaque.” As blood vessels build up plaque over time, the insides of the vessels narrow. This narrowing blocks blood flow to and from the heart and other organs and eventually causes heart disease or stroke.
Inclisiran, potentially the first cholesterol-lowering therapy in the siRNA (small-interfering RNA) class, is an investigational twice-yearly therapy following initial and three-month doses in Phase III clinical development. 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.
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach more than 750 million people globally and we are finding innovative ways to expand access to our latest treatments. About 105 000 people of more than 140 nationalities work at Novartis around the world. Find out more at www.novartis.com.
In the UK, we employ approximately 1,500 people to serve healthcare needs across the whole of the UK, as well as supporting the global operations of Novartis. Since 2014, Novartis has invested over £200 million in R&D and is a leading sponsor of clinical trials, in the UK. For more information, please visit www.novartis.co.uk