Novartis to Support Roche in Scaling Up Production of Actemra/RoActemra (Tocilizumab) Amid COVID-19 Pandemic

April 15, 2021 News /BioonBIOON/ -- Novartis and Roche recently jointly announced that the two parties have signed an initial agreement,NovartisRetain production capacity and implement technology transfer for the manufacture of the active pharmaceutical ingredient (API) for Roche’s anti-inflammatory drug Actemra/RoActemra® (Chinese brand name: Yameiluo®; generic name: tocilizumab). Actemra/RoActemra is an IL-6 receptor inhibitor approved for multiple indications, including rheumatoidRheumatoid Arthritis（RA）。

Currently, Actemra/RoActemra is also being used in multipleClinical Trialto conduct tests to study the safety and efficacy of treating COVID-19-related pneumonia. Under the terms of the preliminary agreement, Roche'sManufacturing ProcessProfessional expertise will be transferred in the second quarter of this year toNovartisAPI Singapore Plant. The initial agreement included technology transfer and process validation.

Steffen Lang, Head of Technical Operations at Novartis and member of the Novartis Executive Committee, stated: “Novartis is fully committed to collaborating with Roche to provide our proven biologic manufacturing capabilities. As one of the largest pharmaceutical manufacturers in the world,”Novartis"can mobilize its manufacturing capabilities in multiple areas."

In March this year, Novartis also announced a preliminary agreement to produce CureVac’s COVID-19 candidate vaccine, CVnCoV, at a new high-tech production facility within its Kundl, Austria plant, to help combat the COVID-19 pandemic. In January of this year, the company also signed a preliminary agreement with BioNTech to manufacture its vaccine at its site in Stein, Switzerland.NovartisThe factory produces COVID-19 vaccines for it.

Actemra/RoActemra is the first humanized interleukin-6 (IL-6) receptor antagonist monoclonal antibody approved for administration via both intravenous (IV) infusion and subcutaneous (SC) injection, with multiple approved indications, including: rheumatoidRheumatoid Arthritis(RA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), giant cell arteritis (GCA), cytokine release syndrome (CRS), Castleman disease, and Takayasu arteritis. Actemra/RoActemra includes intravenous (IV) formulations and subcutaneous (SC) pre-filled syringe (PFS) formulations, with specific indications varying by country and region. To date, Actemra/RoActemra has been approved in more than 110 countries worldwide.

In March this year, the U.S. FDA approved a new indication for Actemra/RoActemra: to slow the rate of decline in lung function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). SSc-ILD is a debilitating condition with very limited treatment options. Notably, Actemra/RoActemra is the first biologic therapy approved by the U.S. FDA for the treatment of SSc-ILD. SSc-ILD is alsoFDAThe sixth approved therapeutic indication for Actemra/RoActemra.

Systemic sclerosis (SSc), also known as scleroderma, is a destructiveAutoimmunitySystemic sclerosis is a progressive, incurable disease that worsens over time. It occurs when immune system dysfunction leads to thickening and hardening of the skin and lung tissues. Approximately 2.5 million people worldwide are affected by systemic sclerosis (SSc). Interstitial lung disease (ILD) may develop in approximately 80% of patients with SSc, causing pulmonary inflammation and fibrosis, and can be life-threatening.

In September 2019, Boehringer Ingelheim’s oral small-molecule tyrosine kinase inhibitor Ofev (nintedanib) capsules received U.S. FDA approval for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). This approval made Ofev the firstFDADrug Approved for the Treatment of This Rare Lung Disease. (Bioon.com)

Original Source: Novartis signs initial agreement to reserve capacity and implement the technology transfer for the production of the active pharmaceutical ingredient for Roche’s Actemra/RoActemra®