Novartis has signed an initial agreement with Roche to help produce its repurposed COVID-19 treatment Actemra/RoActemra.
Actemra/RoActemra (tocilizumab) is already approved to treat a number of inflammatory conditions, including rheumatoid arthritis, paediatric juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, giant cell arteritis and CAR-T cell-induced cytokine release syndrome.
During the COVID-19 pandemic, Roche repurposed the drug to evaluate its potential benefit against the novel virus.
Earlier this year, the UK-based RECOVERY trial found that Roche’s anti-inflammatory drug reduced the risk of death in patients hospitalised with COVID-19
Tocilizumab was found to reduce the relative risk of death by 14% when used alongside the steroid medication dexamethasone in COVID-19 patients requiring oxygen in the RECOVERY trial.
Researchers discovered that 29% of patients in the tocilizumab group died within 28 days compared to 33% of patients in the placebo group, which is an absolute difference of 4%.
The drug reduced the chance of death or the need for mechanical ventilation from 38% to 33%.
Treatment with tocilizumab, plus dexamethasone, also reduced the time patients spent in hospital by five days, the researchers found.
Roche will transfer the manufacturing process expertise to Novartis’ Drug Substance Singapore site during the second quarter of 2021, with the initial agreement covering the technology transfer and the process validation.
“Novartis is fully committed to collaborating with Roche in offering our proven biologics production capabilities,” said Steffen Lang, head of Novartis technical operations and member of the Novartis executive committee.
“As one of the world’s largest producers of medicines, Novartis can mobilise its manufacturing capabilities on multiple fronts,” he added.
In March, Novartis signed an initial manufacturing agreement with CureVac to help manufacture the latter’s mRNA-based COVID-19 vaccine candidate CVnCoV.
Novartis plans to manufacture the mRNA and bulk drug product for CureVac’s CVnCoV of up to 50 million doses by the end of 2021, with further scale-up to 200 million doses in 2022.
Deliveries of the CVnCoV doses from Novartis’ Kundl, Austria manufacturing site are expected to begin in summer 2021.
“At the Kundl site, Novartis is a pioneer and has decades of experience in pharmaceutical production of proteins and in more recent years of nucleic acids. We are currently expanding our site with additional capacities for the production of mRNA in order to best serve the increasing demand,” commented Lang.