With today’s $12 billion purchase of Santa Monica-based Kite Pharma, Gilead has not only validated the CAR-T industry, but also put a price on what the technology is worth. With their product likely to new approved by November, Kite has been recognized as an industry leader in the emerging field of cell therapy, which uses a patient’s own immune cells to fight cancer. The company has developed engineered cell therapies that express either a chimeric antigen receptor (CAR) or an engineered T cell receptor (TCR), depending on the type of cancer. Kite’s most advanced therapy candidate, axicabtagene ciloleucel (axi-cel), is a CAR T therapy currently under priority review by the U.S. Food and Drug Administration (FDA).
The buyout moves Gilead into a leading position in the adoptive cell therapy market, competing with Novartis’ bioengineered T-cell drug CTL019 (which got a favorable decision from an Food and Drug Administration [FDA] Advisory Committee back in July and which should get FDA approval earlier than Kite’s axe-cel). Although several other companies are developing the CAR-T therapies, axi-cel is awaiting an FDA decision for non-Hodgkin lymphoma (that decision is due by November 29). Although the approval seems pretty certain, there has been questions about whether Kite could capitalize on the treatment before competition hits the market.
Axi-cel’s peal sales could be as high as $2 billion per year, but for their $12 Billion that Gilead is also getting a significant pipeline of next generation cancer therapies. Its new blood cancer therapy, axi-cel, faces questions about competition, the complexity of its manufacturing process and how it will be paid for by insurers.
“The acquisition of Kite establishes Gilead as a leader in cellular therapy and provides a foundation from which to drive continued innovation for people with advanced cancers,” said John F. Milligan, PhD, Gilead’s President and Chief Executive Officer. “The field of cell therapy has advanced very quickly, to the point where the science and technology have opened a clear path toward a potential cure for patients. We are greatly impressed with the Kite team and what they have accomplished, and share their belief that cell therapy will be the cornerstone of treating cancer. Our similar cultures and histories of driving rapid innovation in order to bring more effective and safer products to as many patients as possible make this an excellent strategic fit.”
Gilead had been looking for an acquisition to diversify its portfolio beyond its leading position in infectious-disease treatments and provide a new revenue stream as sales of the company’s hepatitis C drugs decline.
The deal for Kite would be one of Gilead’s biggest, more than the $11 billion purchase of liver-disease drugmaker Pharmasset in 2012, which provided Gilead with hepatitis C therapies that are among the world’s top-selling drugs.
About CAR-T
CAR-T is different from typical small molecule or biologic therapies because it is manufactured for each individual patient using their own cells. During the treatment process, T cells are drawn from a patient’s blood and reprogrammed in the manufacturing facility to create T cells that are genetically coded to express a chimeric antigen receptor to recognize and fight cancer cells and other B-cells expressing a specific antigen.