Kite to Receive Upfront Payment of $40 Million, Milestone Payments,
Profit Share and Sales Royalties Upon Commercialization of
Axicabtagene Ciloleucel (approved USAN name for KTE-C19) in China
Fosun Pharma to Provide $20 Million in Initial Funding to Support
Clinical Development and Manufacturing Activities of the Joint Venture
50/50 Owned Joint Venture to be Based in Shanghai
Initial Focus on Development, Manufacturing and Commercialization of
Axicabtagene Ciloleucel with Option to Include Additional Products
Including Two T Cell Receptor Product Candidates
SANTA MONICA, Calif. & SHANGHAI--(BUSINESS WIRE)--
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
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.
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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
View source version on businesswire.com: http://www.businesswire.com/news/home/20170110005587/en/
SVP, Corporate Communications &
VP, Investor Relations
Source: Kite Pharma, Inc.
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