SAN FRANCISCO — Novartis and the U.K. government are planning to run a large-scale clinical trial to test the Swiss pharma's new heart drug inclisiran as a preventive therapy for people at high cardiovascular risk, the drugmaker said Monday on the first day of the J.P. Morgan Healthcare conference.
The deal was negotiated and signed by inclisiran's original developer The Medicines Company, which Novartis spent nearly $10 billion to acquire last month. Novartis has blockbuster sales ambitions for the drug and is expecting to file for European approval in the first three months of 2020.
The collaboration, Novartis said, would also establish a "world-first" population-level agreement to provide inclisiran to British patients with established heart disease, and set up a consortium to find ways of improving manufacturing for drugs like inclisiran.
For the U.K., the agreement is expected to contribute to its long-term national goal of preventing 150,000 cardiovascular-related deaths over a decade.
While inclisiran is now at the center of Novartis' plans in heart disease, acquiring the Medicines Co. wasn't high on the pharma's agenda a year ago, Novartis CEO Vas Narasimhan said Monday. But clinical data that emerged this year from the RNA-targeting therapy changed the company's view, leading the chief executive to talk up a billion-dollar future for the heart drug.
"I believe inclisiran has the potential to be one of the largest, if not the largest, medicine at Novartis in our history," Narasimhan said Monday in a session at the JPM conference.
At a press conference later in the day, Narasimhan added inclisiran could potentially become a treatment akin to a vaccine for heart disease.
To determine that potential, Novartis will run the primary prevention trial with significant help from U.K. health officials. These outcomes trials are huge multi-year affairs, often requiring more than $1 billion to run with tens of thousands of patients, experts said.
“As a former vaccine clinical trialist, doing large-scale studies can be immensely expensive," said Narasimhan. "To find a way to do this through leveraging the NHS data systems and technologies that the U.K. have invested in, enables us to do a primary prevention study in a much more cost-effective way," he said, referring to Britain's National Health Service.
While the details on the study's design are still being worked out, he expects it to enroll a vast majority of patients from the U.K. and is aiming for it to be inclisiran's pivotal study in the primary prevention population.
John Bell, a professor who led the U.K. government's life sciences strategy, called the cost savings from this new approach "eye-watering" compared to a typical study.
"The advantage of this methodology is you go immediately to the population you want to recruit," Bell said. "The whole front end, which can take years, gets completely reduced to something that is really simple."
While Novartis now leads the initiative, these ideas originated from The Medicines Co. founder and former CEO Clive Meanwell, along with his successor, Mark Timney.
Meanwell said Monday the secondary trial of inclisiran, ORION-4, "sprung some interesting discussions about how you would take on the primary prevention question."He added the U.K.'s National Institute for Health and Care Excellence was involved from the the first meeting, and thinks without that early relationship, this collaboration never would have gotten this far.
"He and Mark have acted as rather effective midwives for this," Bell said, "and the baby's delivered and dropped in Vas's lap."