Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company
dedicated to the discovery, development, and commercialization of
novel therapies for the treatment of cancer, today announced that
it has expanded its strategic partnership with Chinese drug
company, Guangzhou Xiangxue Pharmaceutical Co., Ltd. (“Xiangxue”),
to exclusively develop and commercialize Athenex’s oncology product
candidates Oral Paclitaxel (both the capsule and the tablet
formulations), Oral Irinotecan, as well as Tirbanibulin (KX2-391,
also known as KX-01) Ointment, including for the treatment of
actinic keratosis (AK) in the Territory.
Under the terms of the license agreement, subject to the
satisfaction of certain conditions, Athenex will receive an upfront
payment of $30 million. Athenex will also be eligible to
receive development, sales and other milestone payments up to $170
million, and tiered royalties ranging from the sub-teen to low
twenties based on annual net sales of licensed products in the
Territory and a percentage of sublicensing revenue. The total deal
size is potentially $200 million, excluding the royalty
payments.
The agreement provides for joint decision making through a Joint
Steering Committee with respect to the development and
commercialization of the licensed products in the Territory.
Athenex and Xiangxue will jointly lead the clinical development
programs with Athenex to coordinate the global drug development
efforts while Xiangxue will oversee commercialization activities in
the Territory.
Mr. YongHui Wang, Chairman and CEO of Xiangxue,
said, "We are thrilled about this strategic partnership extension
with Athenex in China which complements our successful
collaboration on KX2-361 (also known as KX-02) for brain tumors
(including glioblastoma multiforme) and TCR-T immunotherapy. Our
collaboration has been highly rewarding, and we have also witnessed
Athenex’s strong execution track record, in terms of research and
development as well as business expansion. The oral paclitaxel and
encequidar data are extremely exciting, with clear benefits on
tumor response, improved survival and less neuropathy. We believe
the results pave the way for oral irinotecan to follow its success.
The promising tirbanibulin data have also shown significant
clinical benefits to patients with AK in two randomized, controlled
clinical studies. Our assessment is that there is compelling market
potential for oral paclitaxel and encequidar in China, and that
tirbanibulin ointment will address an underserved market in
AK.”
“This extended strategic partnership, together with KX2-361,
expands our novel drug portfolio into a strong pipeline consisting
of two Phase 3 product candidates with positive clinical trial
results, one product candidate with proof-of-concept data that is
ready to advance to Phase 2, and one Phase 1 product candidate,”
continued Mr. YongHui Wang. “We expect the partnership will enable
us to lead these innovative therapies into commercialization and
position us to further tap into one of the largest and most
promising healthcare markets worldwide. We will be expanding our
marketing and sales capacity to allow us to maximize the potential
of these exciting opportunities.”
Dr. Johnson Lau, Chief Executive Officer and Chairman of
Athenex, stated, “We are pleased with the extension on the
strategic partnership with Xiangxue, and their confidence in our
clinical data. We believe this serves as an important validation of
our science and product portfolio. We have selected Xiangxue
as our partner based on our long term productive collaboration, and
because their commitment to develop this portfolio is aligned with
our global strategy. Xiangxue also plans to expand its marketing
and sales infrastructure to focus on China to capture the full
potential of these products. We look forward to leading the global
clinical development of these advanced clinical stage products with
the ultimate goals of serving patients and addressing the
attractive market opportunities that exist in China.”
The Orascovery platform was initially developed by Hanmi
Pharmaceuticals and licensed exclusively to Athenex for all major
worldwide territories except Korea, which is retained by Hanmi.
Athenex has an exclusive license agreement with Almirall, S.A.
to the rights to tirbanibulin ointment in the following
territories: USA, European Union, Russia and Turkey. Details of
this arrangement were disclosed in December 2017.
About Athenex, Inc.Founded in 2003, Athenex,
Inc. is a global clinical stage biopharmaceutical company dedicated
to becoming a leader in the discovery, development and
commercialization of next generation drugs for the treatment of
cancer. Athenex is organized around three platforms, including an
Oncology Innovation Platform, a Commercial Platform and a Global
Supply Chain Platform. The Company’s current clinical pipeline is
derived from four different platform technologies: (1) Orascovery,
based on non-absorbed P-glycoprotein inhibitor, (2) Src kinase
inhibition, (3) T-cell receptor-engineered T-cells (TCR-T), and (4)
Arginine deprivation therapy. Athenex’s employees worldwide are
dedicated to improving the lives of cancer patients by creating
more active and tolerable treatments. Athenex has offices in
Buffalo and Clarence, New York; Cranford, New Jersey; Houston,
Texas; Chicago, Illinois; Hong Kong; Taipei, Taiwan; multiple
locations in Chongqing, China; Manchester, UK; Guatemala City,
Guatemala and Buenos Aires, Argentina. For more information, please
visit www.athenex.com.
About Guangzhou Xiangxue Pharmaceutical Co., Ltd.
(XPH)XPH was founded in 1997 and is located in Guangzhou
Science City, Guangzhou Economic & Technical Development
District (GETDD), which is part of the core area of Guangdong, Hong
Kong and Macao, or the Greater Bay Area. XPH is a high-tech
enterprise integrating manufacturing, operation and R&D of
products including pharmaceuticals, biological medicine, functional
food, Chinese medicines and medical devices. XPH is recognized as
one of pharmaceutical enterprises with most development potential
in the industry in China and was listed in Shenzhen Stock Exchange
in 2010 (stock code: 300147). XPH has directed its attention to
leading biomedical technologies since 2012. XPH has built an
international cooperative innovation system focusing on focused
scientific research led by talent teams to introduce new medical
innovative technologies. One important focus is on clinical
immunotherapy development using the cutting-edge technologies
involving high affinity specific T-cell receptor (TCR). Xiangxue
Life Sciences (XLifeSc) is a wholly-owned subsidiary of Xiangxue
Pharmaceutical, focused on TCR-based therapies for cancer and has
developed a new generation TCR-T, named TAEST (TCR affinity
enhanced specific T-cell-therapy), consisting of the expression of
affinity enhanced T-cell receptors on the engineered T-cells to
target HLA-antigenic peptide complex on certain types of cancer
cells. Early clinical studies in China demonstrated a good safety
profile in patients. For more information about XPH, visit
www.xphcn.com
Forward-Looking StatementsExcept for historical
information, all of the statements, expectations, and assumptions
contained in this press release are forward-looking statements.
These forward-looking statements are typically identified by terms
such as “anticipate,” “believe,” “continue,” “could,” “estimate,”
“expect,” “foresee,” “goal,” “guidance,” “intend,” “likely,” “may,”
“plan,” “potential,” “predict,” “preliminary,” “probable,”
“project,” “promising,” “seek,” “should,” “will,” “would,” and
similar expressions. Actual results might differ materially
from those explicit or implicit in the forward-looking statements.
Important factors that could cause actual results to differ
materially include: the development stage of our primary clinical
candidates and related risks involved in drug development, clinical
trials, regulation, manufacturing and commercialization; our
reliance on third parties for success in certain areas of Athenex’s
business; our history of operating losses and need to raise
additional capital to continue as a going concern; our ability to
integrate CIDAL’s assets into our existing operations; competition;
intellectual property risks; risks relating to doing business in
China; the uncertainty of when, if at all, we will be able to
resume producing API in our Chongqing plant; and the other risk
factors set forth from time to time in our SEC filings, copies of
which are available for free in the Investor Relations section of
our website at
http://ir.athenex.com/phoenix.zhtml?c=254495&p=irol-sec or upon
request from our Investor Relations Department. All information
provided in this release is as of the date hereof and we assume no
obligation and do not intend to update these forward-looking
statements, except as required by law.
CONTACTSInvestor Relations:Tim McCarthyManaging
Director, LifeSci Advisors, LLCDirect: 212-915-2564
Athenex, Inc.:Randoll SzeChief Financial
OfficerEmail: RandollSze@athenex.com
Jacqueline LiCorporate Development and Investor RelationsEmail:
JacquelineLi@athenex.com
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