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® | Novartis
- Initial agreement covers reservation of the large-scale state-of-the-art biologics facility in Singapore site for the production of the active pharmaceutical ingredient for Roche’s Actemra/RoActemra®
- Follows recent initial agreements for providing manufacturing capacity for CureVac and BioNtech
Basel, April 15, 2021 — Novartis has signed an initial agreement with Roche to reserve capacity and implement the technology transfer for the production of the active pharmaceutical ingredient (API) for Roche’s Actemra/RoActemra® (tocilizumab), a treatment for rheumatoid arthritis which is also being tested in various clinical trials investigating the safety and efficacy in COVID-19 associated pneumonia.
Under 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 this year. The initial agreement covers 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 mobilize its manufacturing capabilities on multiple fronts.”
Actemra/RoActemra® is also approved for the treatment of paediatric juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, giant cell arteritis and CAR-T cell-induced cytokine release syndrome. Actemra/RoActemra® is available in both subcutaneous and intravenous formulations.
In March, Novartis announced an initial agreement to manufacture the mRNA and bulk drug product for the COVID-19 vaccine candidate CVnCoV from CureVac to aid in the fight against the COVID-19 pandemic in a new high-tech production facility at the Novartis site in Kundl, Austria. And in January, an initial agreement with BioNtech was also signed to provide manufacturing capacity for a COVID-19 vaccination at the Novartis site in Stein, Switzerland.
This media update contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding the agreement with Roche to reserve capacity and implement the technology transfer for the production of active pharmaceutical ingredient, or regarding potential future revenues from such agreement. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the agreement with Roche to reserve capacity and implement the technology transfer for the production of active pharmaceutical ingredient will achieve its objectives in any particular time frame, or at all. Nor can there be any guarantee that the planned technology transfer will succeed. In particular, our expectations regarding this agreement and such technology transfer could be affected by, among other things, the uncertainties inherent in development and manufacturing processes, and technology transfers; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise.
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