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Novartis, Juno face production hurdles for new blood cancer drugs

The logo of Swiss pharmaceutical company Novartis is seen on its headquarters building in Basel, Switzerland October 27, 2015.

As drugmakers including Novartis, Juno Therapeutics and Kite Pharma race to launch what may be the most effective treatments ever seen for leukemia and other blood cancers, they are grappling with how to make them widely available in a reliable and cost-efficient way.

The new therapies, known as CAR T cells, are made by extracting immune system T cells from an individual patient, altering their DNA to sharpen their ability to spot and kill cancer cells, and infusing them back into the same patient. In some early-stage clinical trials, the treatments eliminated all trace of leukemia and lymphoma in 40 percent to 90 percent of patients who had run out of other options.

Industry analysts expect CAR T cell therapies will begin to reach the market in 2017 and command prices of up to $450,000 if such remarkable results are replicated in larger trials. The cost is for a one-time application after which, if it works, signs of the cancer are eliminated and the patient needs no more treatment.

"CAR T cell treatments are one of great advances in cancer therapy in the last decade," said Dr. James Ferrara, head of hematological cancer research at Mount Sinai Hospital in New York, who has not personally tested them, but believes they could become the standard of care among the estimated 10,000 U.S. patients who have exhausted other treatment options. "In patients that have been unresponsive to the most effective therapies we have, including bone marrow transplants, leukemia seems to completely disappear."

But the production process takes about two weeks per patient, representing a challenge to provide individualized medications for large numbers of people. Wall Street expects Swiss-based Novartis, which owns a New Jersey plant already producing CAR T cells for its clinical trials, to seek approval next year for the first CAR T cell therapy, months before its smaller rivals. Novartis bought the facility in 2013 from Dendreon, whose Provenge treatment for prostate cancer also required a personalized manufacturing process but failed to take off, leading the company into bankruptcy.

"We feel confident we can scale up to thousands of patients a year with a true global facility," said Usman Azam, Novartis' head of cell and gene therapies. That would be enough to satisfy commercial demand for at least a few years after the treatment is first approved, he said, adding that a second plant could be...