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Gilead will gain a robust pipeline of cell therapy products, with one lead candidate, a CAR T therapy, anticipated to gain FDA approval in the fourth quarter.
On Aug. 28, 2017, Gilead Sciences announced it has agreed to acquire Kite Pharma (Santa Monica, CA), a cell therapy company, for $180 per share in cash, or approximately $11.9 billion. The transaction was unanimously approved by both the Gilead and Kite boards of directors and is anticipated to close in the fourth quarter of 2017.
Under the merger agreement, a wholly owned subsidiary of Gilead will promptly commence a tender offer to acquire all of the outstanding shares of Kite’s common stock at a price of $180 per share in cash. Following successful completion of the tender offer, Gilead will acquire all remaining shares not tendered in the offer through a second-step merger at the same price as in the tender offer.
Among the benefits Gilead will gain is a robust pipeline of cell therapy products. Kite 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 lead therapy candidate, axicabtagene ciloleucel (axi-cel), is a CAR T therapy currently under priority review by FDA for treating refractory aggressive non-Hodgkin lymphoma (NHL), which includes diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL). FDA has set a target action date of Nov. 29, 2017 under the Prescription Drug User Fee Act.
A marketing authorization application has also been filed for axi-cel for treating relapsed/refractory DLBCL, TFL, and PMBCL with the European Medicines Agency, representing the first submission in Europe for a CAR T therapy. Approval in Europe is expected in 2018. Kite has additional candidates in clinical trials in both hematologic cancers and solid tumors, including KITE-585, a CAR T therapy candidate that targets B-cell maturation antigen expressed in multiple myeloma.
“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 Milligan, PhD, Gilead’s president and CEO, in a company 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. 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.”
Research and development as well as the commercialization operations for Kite will remain based in Santa Monica, CA, with product manufacturing remaining in El Segundo, CA.
“From the release of our pivotal data for axi-cel, to our potential approval by FDA, this is a year of milestones. Each and every accomplishment is a reflection of the talent that is unique to Kite. We are excited that Gilead, one of the most innovative companies in the industry, recognized this value and shares our passion for developing cutting-edge and potentially curative therapies for patients,” said Arie Belldegrun, MD, FACS, chairman, president and CEO of Kite, in a company press release. “CAR T has the potential to become one of the most powerful anti-cancer agents for hematologic cancers. 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.”
Source: Gilead Sciences