Novartis global centre for major cardiovascular clinical trial

Pharma News: Novartis reaffirmed its commitment to the UK as it announced the country will become the global centre of a major new clinical trial to investigate the use of inclisiran in improving cardiovascular outcomes (including heart attack or stroke) by reducing Low Density Lipoprotein Cholesterol (LDL-C).

The announcement is made on the same day the company formally opens its new headquarters in White City, London, and pledged to expand its digital Biome programme to the UK.

Novartis is currently planning a primary prevention study with inclisiran in the UK, building on the methods used to recruit 500,000 patients into the UK Biobank and to conduct ORION-4, the ongoing study for patients who have already had a heart attack or stroke. This second study would see the UK become the global trial centre. Novartis will work in partnership with the Nuffield Department of Population Health at Oxford University, the NHS and the National Institute for Health Research (NIHR) as part of this programme.

In addition, the innovative collaboration between Novartis and the NHS pioneers a world-first, population health model to a large at-risk patient population with atherosclerotic cardiovascular disease. Following regulatory approval and the National Institute for Health and Care Excellence (NICE) assessment, the proposed population-level agreement would provide access to treatment for secondary prevention ASCVD patients as part of a distribution programme for patients not reaching their LDL-C target on statins alone.

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“As a company working to improve and extend human life, we’re optimistic about today’s announcement and what this could mean in the ongoing battle against cardiovascular disease—the world’s leading cause of death and disability. We see the UK, with its deep commitment to life sciences, as an attractive place to reimagine medicine,” commented Vas Narasimhan, Chief Executive Officer at Novartis.

“This new trial offers an important opportunity to test the ability of inclisiran to lower the risk of heart disease and stroke in a broad range of people. At the same time, it will demonstrate how a new generation of streamlined trials can provide reliable information about novel treatments for conditions that affect large numbers of NHS patients,” commented Sir John Bell, Regius Professor of Medicine at Oxford University.

Last week Novartis formally opened their new UK headquarters in White City Place which is quickly becoming home to several pioneering life sciences companies at the forefront of innovation and will bring Novartis in close proximity to Imperial College London’s major new research and innovation campus.

“The UK life sciences sector is at a crossroads, with many opportunities available for cutting-edge innovation and partnerships. White City is fast becoming one of the UK’s most exciting new hubs for life sciences, and puts us in the perfect position to continue working with our partners to find new ways to innovate and collaborate to build a healthier tomorrow,” commented Haseeb Ahmad, Managing Director, UK, Ireland and Nordics, Novartis Pharmaceuticals and Country President, Novartis UK.

Professor Alice Gast, President of Imperial College London, said “Novartis is a leader in the world of medicines and we welcome them to White City. Their move is another sign that White City is becoming a vibrant and exciting life sciences cluster. There are unprecedented opportunities for academia, businesses and entrepreneurs in White City as our campus provides strength and leadership in molecular sciences, bioengineering and public health and close proximity to our medical research and translation work at Hammersmith Hospital. Imperial and Novartis’ proximity will enhance our collaboration as we work together to tackle healthcare challenges of our time”.

In further confirmation of the Novartis commitment to the UK, the company confirmed it will expand its Biome programme to the UK. The Novartis Biome is a digital innovation lab that aims to empower and engender health tech companies and people passionate about disrupting healthcare through the use of data and digital technologies. The Novartis Biome is being built for entrepreneurs with a shared passion to innovate healthcare by solving real-world problems. It is intended to open up access to key Novartis resources, including relevant datasets, mentorship and customised curriculums.

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