Novartis wasn’t kidding when it said it wanted to help with the global COVID-19 fight earlier this year. The company racked up back-to-back manufacturing pacts with Pfizer-BioNTech and CureVac, and, now, it’s taking the battle to the therapeutic front.
Novartis has penned an initial deal with Roche to reserve active pharmaceutical ingredient (API) capacity for the company’s rheumatoid arthritis med Actemra, which has run the gamut of COVID-19 trials over the past year—some successful and others not.
Novartis will hold space at its drug substance facility in Singapore, where the partners expect the technology transfer to occur in the second quarter. The initial deal covers tech transfer and process validation, while the eventual plan is for Novartis to produce the API and ship it back to Roche, a company spokesperson said via email. Exact quantities will be determined by Roche, she added.
Novartis didn't specify a timeline for production to start.
The drugmaker is "fully committed to collaborating with Roche in offering our proven biologics production capabilities,” Steffen Lang, Ph.D., head of technical operations at Novartis, said in a statement. “As one of the world’s largest producers of medicines, Novartis can mobilize its manufacturing capabilities on multiple fronts.”
So far in 2021, the Swiss Big Pharma has done just that. In late January, the company penned an initial agreement allowing Pfizer’s mRNA partner BioNTech to use its facility in Stein, Switzerland, for COVID-19 vaccine production. Manufacturing is pegged to start in the second quarter, with deliveries expected to roll out in the third quarter.
“We expect this to be the first of a number of such agreements,” Lang said in a statement at the time.
Then, in March, Novartis tied up with another German mRNA specialist—CureVac—to produce mRNA and bulk drug substance for the biopharma’s late-stage pandemic vaccine. The partners hope to boost CureVac’s overall vaccine capacity by 50 million doses in 2021 and 200 million doses by next year.
Despite a number of authorized vaccines now rolling out across the globe, the industry has continued to stumble on COVID-19 treatments.
Actemra, for its part, has been a mixed bag. Early this year, a non-peer-reviewed trial sponsored by the U.K.'s National Institute for Health Research showed the med, as well as Sanofi and Regeneron's fellow IL-6 inhibitor Kevzara, could cut hospital stays for COVID-19 patients sent to intensive care by 10 days. The meds also lowered the risk of death by 24% in patients who got either drug within a day of admission.
With those data in hand, the U.K. government urged the National Health Service to roll out the treatments for COVID-19.
Two months later, Roche disclosed phase 3 results showing Actemra plus Gilead Sciences' approved COVID-19 treatment Veklury, also known as remdesivir, didn't reduce the time patients with severe COVID-19 spent in the hospital versus Veklury alone.
It's a familiar trajectory for Actemra during the pandemic. In Roche's COVACTA trial, Actemra failed to beat placebo at improving clinical status or preventing death in severe COVID-19 patients. The silver lining, albeit not statistically significant, was a positive trend suggesting Actemra might shorten the time to hospital discharge.
It fared better in the EMPACTA trial, which showed Actemra cut the risk of mechanical ventilation in patients who already needed some oxygen support. It failed to distinguish itself from placebo on death rate, but, again, there was some suggestion Actemra might help patients get out of the hospital sooner.
Meanwhile, Roche reported a large increase in Actemra sales last year. The drug generated about $2.9 billion, a 32% increase from the prior year. The drugmaker noted that several countries included Actemra in their severe COVID-19 treatment guidelines. Sales increases came from the U.S., Russia, India and Spain, Roche said.