SAN FRANCISCO—In a multibillion-dollar bet on the cholesterol drug candidate inclisiran, Novartis late last year picked up the Medicines Company in one of 2019's largest biopharma M&A deals. Now, it's unveiled a partnership with the British government to make the as-yet-unapproved med widely available for high-risk cardiovascular disease patients.
At the J.P. Morgan Healthcare Conference, Novartis CEO Vas Narasimhan and British health officials said they'd agreed to provide the drug—after it’s cleared by regulators and reviewed by cost watchdog NICE—to high-risk patients.
Negotiated and signed with MedCo before Novartis bought the company, the “population-level agreement” would be a world-first, officials said. As a novel approach, it could inspire similar deals in other markets. And it could pose a threat to rival PCSK9 drugs Repatha, from Amgen, and Praluent, from Regeneron and Sanofi—both of which have never lived up to their initial hype.
Aside from the access deal, Novartis and England’s National Health Service plan to study the drug in a large-scale clinical trial in primary prevention patients with atherosclerotic cardiovascular disease.
The deal “demonstrates how this medicine in particular can transform population health like few other drugs could in the past," Narasimhan said Monday.
Inclisiran is currently in phase 3 testing in secondary prevention patients, a group that already has cardiovascular disease. Treatment is aimed at preventing the disease from worsening and staving off CV events such as heart attacks. In primary prevention patients, treatment aims to stop the disease from developing—and, as such, could form a much bigger market for the Novartis drug if it proves itself.
Officials expect the drugmaker to file the med for its initial indication in Europe during the first quarter of 2020, according to NHS.
Inclisiran has generated considerable interest in biopharma over the last year as data this summer showed the drug is as effective as the existing PCSK9 therapies. At the American Heart Association Scientific Sessions in November, the company released late-stage data showing the med helped patients dramatically cut their LDL cholesterol.
Amgen, Regeneron and Sanofi launched their PCSK9 drugs in 2015, but the treatments never lived up to original expectations. Payers didn’t want to cover their high prices—around $14,000 per year before discounts when they launched—so they played hardball with the drugmakers.
The companies ended up offering high rebates to secure access, and more recently have deeply discounted the drugs. Further, Sanofi is “right-sizing” its investment in Praluent under new CEO Paul Hudson, a former Novartis exec.
With Novartis taking over inclisiran's launch, the rival companies will have yet another challenge ahead, particularly in England, where patients will have access to the new option under the Novartis and NHS partnership.