Novartis (NVS) Collaborates with Roche for API of RA Drug Actemra
Zacks Investment Research | Apr 16, 2021 04:07AM ET
Swiss pharma giant Novartis RHHBY (OTC:RHHBY) to reserve capacity and implement the technology transfer for the production of the active pharmaceutical ingredient (API) for the latter’s rheumatoid arthritis drug, Actemra/RoActemra (tocilizumab).
The safety and efficacy of the drug, which is already approved for the treatment of pediatric juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, giant cell arteritis and CAR-T cell-induced cytokine release syndrome, is being evaluated in various studies for COVID-19-associated pneumonia.
Per the terms of the initial agreement, the manufacturing process expertise of Roche will be transferred to the Novartis Drug Substance Singapore site during the second quarter of this year. The initial agreement covers the technology transfer and process validation.
This is the third manufacturing deal for Novartis, as last month, it announced an agreement to manufacture the mRNA and bulk drug product for CureVac’s CVAC COVID-19 vaccine candidate, CVnCoV.
In January, Novartis announced an agreement with BioNtech BNTX to provide manufacturing capacity for a COVID-19 vaccination at the Novartis site in Stein, Switzerland. Novartis has also collaborated with Molecular Partners to develop two DARPin therapies designed for potential use against COVID-19.
Novartis’ shares have lost 7.2% in the year so far against the industry ’s growth of 0.6%.
Meanwhile, Novartis also announced new encouraging post hoc data from the phase III ASCLEPIOS studies. Data showed that Kesimpta (ofatumumab) reduced the risk of disability progression independent of relapse activity (PIRA) up to almost 60% compared to the first-line treatment with Aubagio in a subgroup of newly diagnosed, treatment-naïve patients with relapsing forms of multiple sclerosis (RMS). The positive data further support Kesimpta as a first-choice treatment option for adults with RMS.
Kesimpta is an anti-CD20 monoclonal antibody that enables the targeted depletion of B-cells, specifically in lymph nodes.
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Last month, the European Commission approved Kesimpta for the treatment of RMS in adult patients with active disease defined by clinical or imaging features. It is approved in the United States to treat RMS including clinically isolated syndrome, relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (SPMS).
Novartis currently carries a Zacks Rank #4 (Sell). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here .
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