Novartis is putting $200 million into its radioligand therapy manufacturing capabilities with a new site in California and the expansion of an existing site in Indianapolis.
The Indianapolis site will produce radioisotopes for the drugmaker’s products Pluvicto and Lutathera. The new location in Carlsbad, CA, will be Novartis’ third radioligand therapy manufacturing site in the US, and is part of an effort to “create resiliency in its manufacturing network and optimize the delivery of medicines to patients on the West Coast,” according to the company.
“We are investing in our supply chain capabilities today to ensure that we are prepared to consistently deliver these complex treatments to the growing number of eligible patients in the long-term,” Novartis US president Victor Bultó said in a statement.
New Jersey-based Novartis struggled with Pluvicto supply last year, with patients sometimes waiting months for the treatment and the company temporarily suspending new patient starts. Then in January, Novartis got the go-ahead from the FDA to manufacture Pluvicto at its facility in Indianapolis to ramp up capacity.
In addition to other radiopharmaceutical products in its pipeline, the company is working on adding an expanded label for Pluvicto. In April, it said it would file with regulators in the second half of this year to treat prostate cancer patients who have been treated with hormone therapy, but not chemotherapy. Pluvicto is currently approved for patients who have had chemo as part of their treatment.
Also in April, Lutathera became the first radiopharmaceutical approved for patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, or GEP-NETs, a rare gut cancer.
Lutathera pulled in $175 million in the second quarter, and Pluvicto had sales of $345 million. The company said in its most recent financial report that “with supply now unconstrained, the focus is on increasing share in established RLT sites, opening new sites and referral pathways, and initiating new patients” on Pluvicto.
A representative for Novartis told Endpoints News that the company currently has a production capacity target of more than 250,000 doses annually in 2024 “and beyond.”