- 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
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.
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
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170110005587/en/
Kite PharmaChristine CassianoSVP, Corporate Communications &
Investor Relationsccassiano@kitepharma.comorGreg MannVP, Investor
Relationsgmann@kitepharma.com
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