Manufacturing quality and costs always play some part in the cost of a new drug, but they are the elephant in the room when looking at CAR-T, personalized cancer medications now under development. That is because of the extensive process to genetically code a patient’s T cells to hunt and kill cancer cells, along with the need for speed.
Instead of grabbing a medicine off the shelf or even infusing a mass-produced biologic at a doctor’s office, the process requires that blood be taken from a patient, cryopreserved, shipped to a facility, reprogrammed and manufactured in the lab, and then shipped back for infusion into the patient, all in the shortest time possible to try to outrun aggressive cancers.
Novartis and Kite, which have the two leading CAR-T candidates, have not provided much insight into pricing. They have, however, given glimpses into their manufacturing and the turnaround times they will need to treat patients for lymphomas.
Novartis talked about manufacturing after it released data on its candidate last week, which will be reviewed by an advisory committee July 12. Novartis officials said that the Swiss company expects to have the turnaround time for its treatment down to 22 days at the time of commercial launch, with 10 to 12 of those days being “the actual cell processing time.”
Santa Monica, California-based Kite says its time is even shorter, although not the 14 days it had initially striven for. “Our manufacturing process delivery time—what we call vein to vein—is between 16 to 18 days,” a spokeswoman said in an email. “This is from the time of leukapheresis to when the cells are back with the clinician for infusion into the patient. This includes 6 to 7 days needed for the cell engineering, as well as quality control and travel time.”
She said the biotech is looking for ways to speed the process further and points out that its manufacturing success rate during clinical trials was 99%.
Novartis is claiming that with continuous process improvements over the course of its Juliet trial, its manufacturing success rate improved to 97% for the last 30 patients. That followed some early issues in which 9 of 141 patients, or 6%, had to discontinue treatment due to “an inability to manufacture an adequate dose of CAR-T cells.”
The company says it has gotten on top of the complicated process. It is now being overseen by Spencer Fisk, who took over as global head cell & gene technical development and manufacturing in Morris Plains, New Jersey, after Karen Walker departed several months ago for a position with Seattle Genetics.
“As for manufacturing, we are confident we will be able to meet the required manufacturing demands moving forward,” a Novartis spokesperson told FierceBiotech last week.
Novartis also has an agreement with the Fraunhofer Institute for Cell Therapy and Immunology for the cell processing of its personalized T cell therapy in Europe.
Kite is producing its chimeric antigen receptor (CAR) and T-cell receptor (TCR) candidate in a new 43,500-square-foot plant it purposely built next to an airport. The plant is estimated to have the capacity to produce up to 5,000 patient therapies per year.
Novartis converted to its use a plant built by the former Dendreon, which used a similar process of altering cells for its once-promising prostate cancer vaccine Provenge. Dendreon sold its 173,000-square-foot plant in Morris Plains, one of three, to Novartis in 2012 for $43 million to pick up some fast cash.
Dendreon’s experience hangs over this new manufacturing method since the company went bankrupt trying to establish Provenge. Its cost of goods at one point was 77%, before it dropped that to about 53% with process changes. That compares to about 10% for many biotechs.
RELATED: Dendreon, done in by expensive, complex manufacturing, files for bankruptcy
While Dendreon failed to find a price point to compete with established, mass-produced drugs, makers of the new cancer drugs will have the luxury of setting a foundational price for their treatments, which have the potential to be curative.
Neither Kite or Novartis have offered any hard guidance on pricing, but Novartis R&D chief Vas Narasimhan has told Bloomberg that stem cell treatment prices could offer a benchmark. Stem cell transplants and follow-up treatment can cost upwards of $800,000. He also said the company is looking at pay-for-performance deals.