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Written by Martin Lynch, European News Editor for Industrial Info (Galway, Ireland)--Novartis is planning to build a new production plant for cell and gene therapies at its Stein site in Switzerland following approval for its chimeric antigen receptor T cell (CAR-T) cancer drug Kymriah by the European Commission (EC).
The company is planning to invest $91 million in the facility, where it said around 260 new jobs will be created initially, with the potential for up to 450 new positions over three years. The first therapies are expected to be available in early 2020 for patients in Europe and Switzerland. Novartis has already established the manufacturing process for Kymriah at the Fraunhofer Institute for Cell Therapy and Immunology in Leipzig, Germany, which currently supports the manufacture of Kymriah for clinical trials worldwide and post-approval manufacturing. The company already operates a cell and gene therapy manufacturing facility in Morris Plains, New Jersey, in the U.S.
"The decision announced today to locate a plant for the production of cell-based therapies in Stein is an example of how Novartis invests in innovative technologies in Switzerland," said Matthias Leuenberger, president of Novartis Switzerland. "It also shows how the production landscape changed. As we invest in new, advanced technologies, the importance of some traditional manufacturing industries will diminish."
Last May, the company announced plans to shed 500 jobs at its Basel headquarters in Switzerland over the next 18 months, while at the same time promising to create 350 new posts, mainly in its biotech business. Novartis employs 13,000 people in Switzerland and a total of 118,000 in 155 countries.
The CAR-T cell therapy Kymriah is for the treatment of B-cell acute lymphoblastic leukaemia in children and young adults. It is described as a "one-time treatment that uses a patient's own T cells to fight cancer" and the only CAR-T therapy to receive regulatory approval in the European Union (EU) for these two distinct B-cell malignancies. Kymriah was also the first CAR-T cell therapy ever approved by the U.S. Food and Drug Administration (FDA).
"The Kymriah approval is a transformational milestone for patients in Europe in need of new treatment options," said Liz Barrett, chief executive officer of Novartis Oncology. "Novartis will continue to build a global infrastructure for delivering CAR-T cell therapies where none existed before, remaining steadfast in our goal of reimagining cancer."
"Bringing Kymriah to patients in the EU advances the treatment paradigm in an unprecedented way and delivers a lifesaving therapy to young patients with ALL who have not been successfully treated with existing therapies, and who have limited options left," added Prof. Peter Bader, head of the division for Stem Cell Transplantation and Immunology and principal investigator of the ELIANA study at the University Hospital for Children and Adolescents in Frankfurt/Main.
Industrial Info Resources (IIR), with global headquarters in Sugar Land, Texas, six offices in North America and 12 international offices, is the leading provider of global market intelligence specializing in the industrial process, heavy manufacturing and energy markets. Our European headquarters are located in Galway, Ireland. Follow IIR Europe on: Facebook - Twitter - LinkedIn For more information on our European coverage send inquiries to info@industrialinfo.eu or visit us online at Industrial Info Europe.
The company is planning to invest $91 million in the facility, where it said around 260 new jobs will be created initially, with the potential for up to 450 new positions over three years. The first therapies are expected to be available in early 2020 for patients in Europe and Switzerland. Novartis has already established the manufacturing process for Kymriah at the Fraunhofer Institute for Cell Therapy and Immunology in Leipzig, Germany, which currently supports the manufacture of Kymriah for clinical trials worldwide and post-approval manufacturing. The company already operates a cell and gene therapy manufacturing facility in Morris Plains, New Jersey, in the U.S.
"The decision announced today to locate a plant for the production of cell-based therapies in Stein is an example of how Novartis invests in innovative technologies in Switzerland," said Matthias Leuenberger, president of Novartis Switzerland. "It also shows how the production landscape changed. As we invest in new, advanced technologies, the importance of some traditional manufacturing industries will diminish."
Last May, the company announced plans to shed 500 jobs at its Basel headquarters in Switzerland over the next 18 months, while at the same time promising to create 350 new posts, mainly in its biotech business. Novartis employs 13,000 people in Switzerland and a total of 118,000 in 155 countries.
The CAR-T cell therapy Kymriah is for the treatment of B-cell acute lymphoblastic leukaemia in children and young adults. It is described as a "one-time treatment that uses a patient's own T cells to fight cancer" and the only CAR-T therapy to receive regulatory approval in the European Union (EU) for these two distinct B-cell malignancies. Kymriah was also the first CAR-T cell therapy ever approved by the U.S. Food and Drug Administration (FDA).
"The Kymriah approval is a transformational milestone for patients in Europe in need of new treatment options," said Liz Barrett, chief executive officer of Novartis Oncology. "Novartis will continue to build a global infrastructure for delivering CAR-T cell therapies where none existed before, remaining steadfast in our goal of reimagining cancer."
"Bringing Kymriah to patients in the EU advances the treatment paradigm in an unprecedented way and delivers a lifesaving therapy to young patients with ALL who have not been successfully treated with existing therapies, and who have limited options left," added Prof. Peter Bader, head of the division for Stem Cell Transplantation and Immunology and principal investigator of the ELIANA study at the University Hospital for Children and Adolescents in Frankfurt/Main.
Industrial Info Resources (IIR), with global headquarters in Sugar Land, Texas, six offices in North America and 12 international offices, is the leading provider of global market intelligence specializing in the industrial process, heavy manufacturing and energy markets. Our European headquarters are located in Galway, Ireland. Follow IIR Europe on: Facebook - Twitter - LinkedIn For more information on our European coverage send inquiries to info@industrialinfo.eu or visit us online at Industrial Info Europe.
