Athenex Announces Strategic Global Initiatives to Expand Clinical Operations
June 28 2019 - 7:00AM
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
the Company has strategically expanded its presence in Europe and
Latin America to grow its global clinical research and development
capacity. The Company believes these initiatives have the potential
to enhance Athenex’s capacity to conduct global clinical studies
and support its regional marketing decision process. They are part
of the Company’s strategy to build on its current strong presence
in U.S. and Asia, and help maximize the global potential of its
pipeline.
Athenex’s oncology-focused pipeline currently has nine clinical
candidates, including two drug candidates in Phase III development.
In line with the Company’s goal to expand its capability and
bandwidth to optimize global development and commercialization of
its pipeline products, Athenex has been evaluating operational
opportunities in Europe and Latin America.
As part of Athenex’s strategy to establish operations in Europe,
the second largest healthcare market in the world, the Company has
formed a subsidiary in the United Kingdom and established offices
in Manchester. The Company is currently conducting clinical studies
in the United Kingdom and intends to continue expanding its
research and development capabilities in the region.
In Latin America, Athenex recently entered into a definitive
agreement to acquire certain assets of CIDAL Limited in exchange
for shares of Athenex common stock, subject to customary closing
conditions. CIDAL is a contract research organization with
headquarters in Guatemala and operations in various countries in
Latin America. CIDAL has provided important CRO services and
support to Athenex, including for its Phase III study of oral
paclitaxel and encequidar for metastatic breast cancer. The asset
purchase is expected to strengthen Athenex’s clinical research and
operations capabilities and support the Company’s clinical
development worldwide.
“These initiatives represent an important step in our ongoing
strategic efforts to expand our clinical research and operations
for global development, with the potential for increased clinical
research efficiencies and cost-effectiveness” said Dr. Johnson Lau,
Chairman and Chief Executive Officer of Athenex. “Our office in
Manchester will enable us to evaluate the best strategy for Europe,
an important market for Athenex. We have been engaging with many
experienced pharma/biotech specialists who are already contributing
to our research programs and look forward to working more closely
with these talents. We are also delighted to extend our operations
in Latin America through CIDAL, which we believe will increase our
bandwidth for clinical research and regulatory development. We
believe having a stronger presence in these territories will
position us well to evaluate new R&D and commercialization
opportunities in Europe and Latin America.”
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; and Manchester, U.K. For more
information, please visit www.athenex.com.
About CIDAL LimitedCIDAL is a contract
research/site management organization, founded in 2002, that
implements and executes Phase I to Phase IV clinical trials in
Latin America and the Caribbean. CIDAL currently operates in 12
Latin American countries: Guatemala, El Salvador, Honduras, Costa
Rica, Panamá, Dominican Republic, Colombia, Perú, Argentina, Chile,
Ecuador, and Brazil. CIDAL’s local knowledge and operational
expertise enabled it to deliver unparalleled ethical, effective and
efficient clinical research services. Moreover, CIDAL has played an
important role in providing training activities to develop
expertise in the region in Good Clinical Practice (GCP). It has
conducted 34 training sessions certifying more than 750
professionals in GCP. In parallel, in a partnership with
Universidad Galileo in Guatemala, CIDAL develops pensum(s) for
Clinical Research Associates (CRAs - Clinical Monitors) and for
Study Coordinators (SC) leading to university certification for
CRAs and (Site) SCs.
Forward-Looking Statements Except 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,” “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 uncertain impact of inspections to be
performed by the Department of Emergency Management of Chongqing on
the production of API in our Chongqing plant and our business
generally; 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.
CONTACTS Investor Relations: Tim McCarthy
Managing Director, LifeSci Advisors, LLC Tel: +1
716-427-2952 Direct: +1 212-915-2564
Athenex, Inc.: Randoll Sze Chief Financial Officer
Email: randollsze@athenex.com Jacqueline Li Corporate
Development and Investor Relations
Email: jacquelineli@athenex.com
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