Novartis has won an approval to sell its landmark CAR-T therapy Kymriah in Japan at a discount price as it continues its slow rollout around the globe while it gradually builds up its manufacturing operations.
Japan’s Central Social Insurance Medical Council offered Novartis a shot at offering the drug to an estimated 216 new cancer patients a year suffering from acute lymphoblastic leukemia and adult patients with diffuse large B-cell lymphoma.
It’s a small market, but a step along CEO Vas Narasimhan’s plan to make Kymriah — with only $45 million in Q1 sales — a blockbuster at some point. The OK in Japan comes with a price of $305,000, compared to $475,000 for ALL patients in the US.
That price has been criticized by a number of groups, including Patients for Affordable Drugs, who believe it should be sold for far less.
A company spokesperson told Reuters that the pharma giant’s rollout in Japan will avoid the challenge on product specification standards that have forced the pharma giant to provide the drug for free sometimes in the US. The FDA set a higher standard for commercial specifications that Novartis has struggled to maintain.
Novartis has also been dogged by an inability to deliver the drug reliably when needed.
In the meantime, Gilead has been making progress with its rival CAR-T — Yescarta, with $96 million in Q1 revenue — as a host of rivals line up off-the-shelf programs aimed at replacing the personalized treatments built with patient cells.
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