Novartis and NHS partner to improve manufacture of oligonucleotides

Henrietta Strickland
January 15, 2020

The three-part deal consists of an access agreement for high-risk patients, a large-scale trial of the gene-silencing PCSK9 inhibitor that is due to get underway this year, and the creation of a consortium with academic groups to try to improve the manufacturing of oligonucleotide drugs like inclisiran in the UK.

Prof Ray said: "This has the potential to overcome a huge issue which is non-adherence to medications which must be taken daily".

The pact also calls for a United Kingdom clinical trial, based on proprietary NHS data, to identify patients at risk of heart disease for whom conventional treatment has not worked, as well as a collaboration on manufacture of cutting-edge drugs like inclisiran, which targets "bad cholesterol", a culprit behind heart attacks and strokes.

The drug, which is pending approval in the US, will seemingly be provided on a "population foundation" to sufferers with atherosclerosis in the United Kingdom once it is tested in a colossal scientific trial and authorised for exhaust there.

Inclisiran is now in phase 3 testing as an add-on to statin therapy in ASCVD patients, with a European filing due late this quarter, but the new agreement means it will be made available in the United Kingdom as quickly and widely as possible after regulatory approval and review by cost-effectiveness watchdog NICE.

Lord David Prior, chair of NHS England, said that the "innovative" collaboration could transform the health outlook of tens of thousands of people living with CVD.

Heart disease is the world's biggest killer and the second biggest cause of death in the United Kingdom and 2 and a half million patients now relying on statins to lower their cholesterol. Providing inclisiran to this high-risk population could make a significant contribution towards meeting the NHS long-term commitment to preventing 150,000 cardiovascular deaths over 10 years. It is a severe disorder and the leading cause of morbidity (sickness) and mortality (death) in most developed countries. "This collaboration has the potential to save 30,000 lives over the next ten years and is proof that the United Kingdom continues to be the world-leading destination for revolutionary healthcare".

Inclisiran is a twice-yearly injection, while Repatha and Praluent are injected every two weeks.

The Swiss pharma giant is now investigating the bi-annual injection in a Phase III trial, with expected European Medicines Agency (EMA) regulatory filing as a preventative add-on treatment to statins for patients who have already been diagnosed with cardiovascular disease later this year.

"If licensed, it will allow the drug to be put through the NICE approval process at the earliest opportunity possible, making it available to NHS patients much earlier", Britain's Department of Health and Social Care (DHSC) said, in response to Reuters questions.

The ground-breaking collaboration includes Novartis, NHS England and the National Institute for Health Research (NIHR) and Oxford University.

We will also collaborate with industry experts, academics and doctors to look into how the United Kingdom can become a pioneer for this type of treatment.

Other reports by Click Lancashire

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