Novartis funnels $300M into early biologic drug manufacturing - BioPharma Dive

Novartis will spend $300 million to bolster its development and production capabilities for biologic medicines, which make up an increasing share of its drug pipeline.

The Swiss drugmaker will invest $110 million in clinical manufacturing capacity in Mengeš, Slovenia and $60 million in development manufacturing capacity at its Schaftenau campus in Austria, to better embed biologics development within existing facilities, it said Monday.

Novartis will also spend $100 million to establish a biologics hub near its Novartis Institutes of BioMedical Research biologics center in Switzerland to foster research and attract talent.

“Collectively these commitments will enhance development processes targeting faster transition times from pre-clinical to first in human studies,” it said.

Biologic medicines are a major part of the pharmaceutical industry’s pipeline, making up about half of recent drug approvals. Novartis is no exception. Its top-selling inflammatory disease drug Cosentyx, with $1.3 billion in sales in the second quarter, and its recently approved multiple sclerosis drug Kesimpta are both monoclonal antibodies.

Its pipeline includes the antibody drug candidates cancer drugs tislelizumab, ociperlimab and sabatolimab, as well as the food allergy treatment ligelizumab, and autoimmune drugs lanalumab and iscalimab. All are in late-stage development or before regulators.

Novartis’ investment in early-stage development and technical know-how could also help it avoid manufacturing missteps as therapies advance through clinical testing and as it expands beyond conventional monoclonal antibodies to more complex medicines.

The investment in biologics comes amid a company reorganization that will cut 8,000 jobs and save $1.5 billion by 2024. Several top executives stepped down earlier this year and the head of its NIBR research arm, well-known researcher Jay Bradner, will leave next month.

In recent years, Novartis has suffered several high-profile manufacturing setbacks. It for years struggled to manufacture its CAR-T cell therapies for leukemia and lymphoma and, in May, suspended production of two radiopharmaceutical drugs because of potential quality issues. A hang-up getting a manufacturing facility inspected also delayed Food and Drug Administration review of its cholesterol drug Leqvio in 2020.

“The science of developing biologics is increasingly sophisticated, and we are excited to meet its challenges head-on,” said Novartis head of biologics technical research Jonathan Novak.

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