Novartis says Dendreon plant deal will drive CAR processing
The purchase of the US FDA-approved manufacturing facility in New Jersey late last year is a positive action in the continuation of its CLT09 therapy, as well as future Chimeric antigen receptor (CAR) immunotherapies. The site is located just 6 miles from Novartis’ US headquarters.
Novartis spokeswoman Julie Masow told in-Pharmatechnologist.com the deal “included the purchase of all fixed assets and all equipment, machineries, utilities, and cell therapy related plant infrastructure.”
Masow said the plant “has the technological competence and equipment to support both clinical and commercial production for CTL019 as well as other therapies in the area of human autologous cellular immunotherapy products.”
She added that Novartis will “retain nearly half of the former employees as they have experience with the production of human cell therapy products.”
CTL019 and CAR Immunotherapies
CAR immunotherapy works by drawing T cells direct from a patient’s blood and encoding them with a set of genetic instructions to seek out and destroy the patient’s cancer cells. When infused back into the patient, the modified T cells help to fight the cancer by effectively becoming part of the patient’s immune system.
CTL019 is Novartis’ first candidate CAR therapy and is currently being studied as a test pilot at the University of Pennsylvania. Other autologous cell therapies have previously been approved by the FDA, including the melanoma targeting therapy Yervoy, acquired by Bristol-Myers Squibb in 2011 and the prostate cancer treatment Provenge.
Provenge was developed by Dendreon and was being processed at the New Jersey plant until the Novartis deal.
Masow confirmed that “Novartis will not manufacture Dendreon products at this facility,” the sale of which followed Dendreon’s decisions to reassess Provenge after slower-than-expected sales.
Despite the $43 million generated by the sale, Dendreon’s finances are still a subject of debate.
Katherine Xu from William Blair & Company expresses doubt over Provenge’s long term profitability, citing competition Johnson & Johnson’s Zytiga – a recently approved prostate drug - as a concern. “Zytiga will likely be sequenced in front of Provenge, because of better efficacy, ease of administration, and stronger cost-benefit arguments.”
