Gilead Sciences Announces $11.9 Billion Purchase of CAR-T Developer Kite Pharma

Gilead Sciences will acquire Kite Pharma by the end of 2017 in an $11.9 billion transaction that will place Gilead at the forefront of chimeric antigen receptor-T (CAR-T) cell therapy development.

The news was announced in a press release issued by both Gilead and Kite. In a deal that is expected to close in the fourth quarter of 2017, Gilead will pay $180 in cash per share, which puts Kite’s valuation at $11.9 billion. The acquisition was unanimously approved by both companies’ Boards of Directors.

The major driver of this substantial valuation is Kite’s work on CAR-T therapy, a form of cancer-fighting immunotherapy. The company had been buoyed by a string of good news regarding its most advanced CAR-T therapy in recent months, from encouraging clinical trial results to its acceptance for priority review by the FDA.

The treatment, axicabtagene ciloleucel, showed positive results in data from the ZUMA-1 study published in March, where it produced a 41% objective response rate and a 36% complete response rate in 101 trial participants with chemotherapy-resistant aggressive B-cell non-Hodgkin lymphoma (NHL). This was followed up in July by results from a trial in 7 patients with diffuse large B-cell lymphoma (DLBCL); 5 demonstrated complete remission and 4 of these remissions were durable long term for as long as 56 months, by the time of publication, without relapse.

In between these 2 promising clinical findings, Kite declared in May that its application for priority review had been accepted by the FDA, meaning the review process will now take just 6 months rather than 10. The target action date set under the Prescription Drug User Fee Act is November 29, 2017. Observers expect it to be approved, which would make it the first CAR-T therapy on the US market for refractory aggressive NHL, including DLBCL, transformed follicular lymphoma, and primary mediastinal B-cell lymphoma.

Besides this frontrunner, known as axi-cel, Kite also has clinical trials ongoing for several other immuno-oncology drug candidates, including the CAR-T therapy KITE-585 for use in multiple myeloma. Gilead expressed enthusiasm about this strong pipeline and the broader future of CAR-T therapy in its announcement of the purchase.

“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, president and CEO of Gilead. “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.”

Kite also voiced excitement about the transaction and its implications for developing more innovative immunotherapies.

“CAR-T has the potential to become one of the most powerful anti-cancer agents for hematologic cancers,” said Arie Belldegrun, MD, FACS, chairman, president, and CEO of Kite, in the joint statement. “With Gilead’s expertise and support, we hope to fulfill that potential by rapidly accelerating our robust pipeline and next-generation research and manufacturing technologies for the benefit of patients around the world.”