Just a few months before the U.S. Food and Drug Administration is expected to reach a decision on Kite Pharma‘s application seeking approval for its therapy axicabtagene ciloleucel (axi-cel) for the treatment of aggressive non-Hodgkin’s lymphoma, the company is being acquired by Gilead Sciences for approximately $11.9 billion.
The FDA had previously granted priority review for Kite’s axicabtagene ciloleucel, and set a target action date of Nov. 29 for its decision.
If axi-cel is approved by the regulatory agency, it will become the first commercially available CAR T-cell therapy for the treatment for refractory aggressive non-Hodgkin’s lymphoma, which includes diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL).
Kite also submitted an application to the European Medicines Agency requesting marketing approval for axi-cel for the the same indications, representing the first submission in Europe for a CAR T-cell therapy. The European Commission is expected to make a decision on whether to approve axi-cel in 2018.
“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,” John F. Milligan, PhD, president and CEO of Gilead, said in a press release.
“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,” Milligan added. “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.”
Gilead will continue promoting the ongoing therapeutic programs of Kite, which include several drug candidates targeting hematologic and solid cancers. These includes the CAR T-cell therapy KITE-585, designed to target the BCMA protein at the surface of myeloma cells, and which is currently in Phase 1 clinical trials.
“From the release of our pivotal data for axi-cel, to our potential approval by the FDA, this is a year of milestones,” said Arie Belldegrun, MD, the chairman, president, and CEO of Kite.
“CAR T has the potential to become one of the most powerful anti-cancer agents for hematologic cancers,” Belldegrun said. “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.”
The transaction, which is expected to close by the year’s end and was unanimously approved by the boards of directors of both Gilead and Kite, agrees that Gilead will purchase Kite for $180 per share, for a value of about $11.9 billion. Both companies are based in California.
According to the press release, the $180 per share acquisition price is a 29 percent premium to Kite’s closing on Aug. 25, and a 50 percent premium to Kite’s one-month average stock price.
Gilead will finance the purchase with a combination of cash on hand, bank debt and senior unsecured notes, the release said.