SANTA MONICA, Calif. & SHANGHAI--(EON: Enhanced Online News)--Kite Pharma (Nasdaq:KITE) and Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma) (600196.SH,02196.HK), today announced a joint venture, Fosun Pharma Kite Biotechnology Co., Ltd. (company name subject to the approval of relevant registration authorities), to develop, manufacture and commercialize axicabtagene ciloleucel in China with the option to include additional products, including two T cell receptor (TCR) product candidates from Kite. Axicabtagene ciloleucel (KTE-C19), Kite’s lead product candidate, is an investigational chimeric antigen receptor (CAR) T-cell therapy under development for the treatment of B-cell lymphomas and leukemias.
“organic growth, external expansion and integrated development”
The joint venture will be registered in Shanghai and owned equally between Kite Pharma, a pioneer in the field of engineered T-cell therapy for cancer, and Fosun Pharma, a leading healthcare group in China.
Under the terms of the agreement, Fosun Pharma will provide the RMB equivalent of $20 million in funding to support clinical development and manufacturing activities and Kite will provide certain technical transfer services to the joint venture. Each party will share in any profits from the joint venture with Kite Pharma receiving 40 percent and Fosun Pharma receiving 60 percent. Kite will also receive an upfront fee of $40 million from the joint venture, funded by Fosun Pharma, regulatory and commercial milestones totaling $35 million and mid-single digit sales royalties for axicabtagene ciloleucel (KTE-C19).
“We are committed to bring engineered T-cell therapy to patients in China who are suffering from cancer,” said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer of Kite. “This joint venture allows us to access a critically important market and meet a major objective of expanding our global reach. Fosun Pharma is an innovator and market-maker, which makes them an ideal partner to develop and commercialize axicabtagene ciloleucel in China. Together, we look forward to addressing significant unmet need in China.”
The joint venture will initially focus on axicabtagene ciloleucel, Kite’s lead CAR product candidate for the treatment of B-cell lymphomas and leukemias. The joint venture will also have the option to license additional product candidates including KITE-439, a TCR therapy directed against the human papillomavirus type 16 E7 oncoprotein and KITE-718, a TCR therapy directed against MAGE A3 and MAGE A6, antigens frequently found in solid tumors including bladder, esophageal, head and neck, lung and ovarian cancers. Opt-in and milestone payments for KITE-439 and KITE-718 could total $140 million plus profit sharing and mid-single digit sales royalties.
“Today’s announcement with a global industry leader in CAR-T and TCR therapy such as Kite, is an important and strategic step to build a long-term foundation for T cell therapy in China,” said Qiyu Chen, Chairman of Fosun Pharma. "This partnership, which leverages each company’s respective strengths, will help us bring novel cancer treatments to patients in need.”
China is the second largest pharmaceutical market in the world after the US. With increasing incidence and mortality, cancer is the leading cause of death in China with over 4 million new cases per year. According to recent estimates, there are approximately 73,000 newly diagnosed cases of non-Hodgkin lymphoma (NHL) in China each year.1
Kite announced in December 2016 that it has initiated the rolling submission to the U.S. Food and Drug Administration (FDA) of the Biologics License Application (BLA) for KTE-C19 as a treatment for patients with refractory aggressive B-cell NHL.
About axicabtagene ciloleucel
Kite Pharma's lead product candidate, axicabtagene ciloleucel, is an investigational therapy in which a patient's T cells are engineered to express a chimeric antigen receptor (CAR) to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells. Axicabtagene ciloleucel has been granted Breakthrough Therapy Designation status for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) regulatory support for DLBCL in the EU.
About Fosun Pharma
Established in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma) (600196.SH,02196.HK) is a leading healthcare group in the PRC. Fosun Pharma strategically covers important segments of the healthcare industry value-chain, including pharmaceutical manufacturing and R&D, healthcare services, medical diagnosis, medical devices manufacturing and agent, as well as pharmaceutical distribution and retail, making contribution to improving people’s health. Fosun Pharma maintains a National Recognized Enterprise Technology Centre and a highly capable international R&D team, focusing on innovation and research of therapeutic areas including cardiovascular system, central nervous system, blood system, metabolism and alimentary system, anti-infection and anti-tumor. With its commitment to innovation for good health and creating a better future, Fosun Pharma will continue insisting on the strategic development approach of “organic growth, external expansion and integrated development,” striving to be one of the leading enterprises in the global healthcare market.
About Kite Pharma
Kite Pharma, Inc., is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a primary focus on engineered autologous cell therapy (eACT™) designed to restore the immune system's ability to recognize and eradicate tumors. Kite is based in Santa Monica, CA. For more information on Kite Pharma, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at http://www.twitter.com/kitepharma.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability of the joint venture to be registered in China, and to develop and commercialize axicabtagene ciloleucel in China; and the expectations regarding the clinical effectiveness and safety of T-cell therapies. Various factors may cause differences between Kite's expectations and actual results as discussed in greater detail in Kite's filings with the Securities and Exchange Commission, including without limitation in its Form 10-Q for the quarter ended September 30, 2016. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Kite assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
1 Cancer Statistics in China, 2015, A Cancer Journal for Clinicians; IMS Health China estimates