Upfront and Milestone Payments Total $250 Million Plus Double Digit
Accelerates Development of Axicabtagene Ciloleucel for Aggressive
Non-Hodgkin Lymphoma (NHL) in Third-Largest Pharmaceutical Market in
SANTA MONICA, Calif.--(BUSINESS WIRE)--
Kite Pharma (Nasdaq:KITE)
announced today that it has entered into a strategic partnership with
Daiichi Sankyo Co., Ltd. (Daiichi Sankyo) for axicabtagene ciloleucel
(approved USAN for KTE-C19) in Japan. Axicabtagene ciloleucel, Kite's
lead product candidate, 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.
Under the terms of the partnership agreement, Daiichi Sankyo will be
responsible for development and commercialization of axicabtagene
ciloleucel in Japan. Daiichi Sankyo will make an upfront payment to Kite
of $50 million and Kite will be eligible to receive future payments
totaling up to $200 million for development and commercial milestones.
Kite is also entitled to receive sales royalties in the low to mid
double digit range.
"We are thrilled to partner with Daiichi Sankyo, a market leader in
Japan who shares our vision for engineered T-cell therapy and has strong
development capabilities in oncology," said Arie Belldegrun, M.D., FACS,
Chairman, President, and Chief Executive Officer of Kite. "We have a
strategic roadmap to commercialize axicabtagene ciloleucel globally
while focusing Kite's development and commercialization efforts in the
United States and Europe. Daiichi Sankyo's commitment to bring
autologous T-cell therapy to patients in Japan will complement our
strategy and demonstrates the significant value in our pipeline, as well
as the commercial potential for autologous T-cell therapy globally."
As part of the transaction, Kite will provide certain technical transfer
services to Daiichi Sankyo. In addition, Daiichi Sankyo has a certain
period of time to license additional Kite product candidates for Japan
including KITE-718, Kite's T cell receptor product candidate targeting
MAGE-A3/A6 and certain other product candidates that proceed to a U.S.
investigational new drug application filing over the next three years.
Upfront and milestone payments for each additional product candidate
could equal up to $200 million plus low to mid double digit sales
royalties. Kite retains all development and commercialization rights
outside of Japan.
"We are very enthusiastic about this partnership with Kite which has the
most advanced technology platform in this area and the potential for
cell-based therapy to change the way in which we treat cancer in Japan,"
said Koichi Akahane, Japan Head of Oncology R&D, Daiichi Sankyo. "We
believe we can leverage the pioneering research conducted by Kite to
potentially accelerate development and commercial availability of
axicabtagene ciloleucel in Japan for those patients suffering from
Japan, the third-largest pharmaceutical market in the world, has
implemented an accelerated approval pathway for regenerative medicine
and cell therapy products under the Pharmaceuticals and Medical Devices
Act (PMD Act) in November 2014. There are approximately 9,300 new cases
of aggressive NHL and 1,400 new cases of acute lymphoblastic leukemia
(ALL) diagnosed per year in Japan, with similar treatment rates and
prescribing patterns as the United States and Europe.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 non-Hodgkin lymphoma (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 Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of
innovative pharmaceutical products to address diversified, unmet medical
needs of patients in both mature and emerging markets. With over 100
years of scientific expertise and a presence in more than 20 countries,
Daiichi Sankyo and its 16,000 employees around the world draw upon a
rich legacy of innovation and a robust pipeline of promising new
medicines to help people. In addition to a strong portfolio of medicines
for hypertension and thrombotic disorders, under the Group's 2025 Vision
to become a "Global Pharma Innovator with Competitive Advantage in
Oncology," Daiichi Sankyo research and development is primarily focused
on bringing forth novel therapies in oncology, including
immuno-oncology, with additional focus on new horizon areas, such as
pain management, neurodegenerative diseases, heart and kidney diseases,
and other rare diseases. For more information, please visit: www.daiichisankyo.com.
Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is a
member of the Daiichi Sankyo Group. For more information on Daiichi
Sankyo, Inc., please visit: www.dsi.com.
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
Daiichi Sankyo to develop and commercialize axicabtagene ciloleucel in
Japan and of Kite to develop and commercialize axicabtagene ciloleucel
in the United States, Europe and other territories; 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 IMS Health, Pharmaceutical and Medical Devices Agency
(PMDA) website, Decision Resources Group and Kite estimates.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170109005381/en/
SVP, Corporate Communications &
VP, Investor Relations
Source: Kite Pharma, Inc.
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