Athenex Announces Strategic Global Initiatives to Expand Clinical Operations

BUFFALO, N.Y., June 28, 2019 (GLOBE NEWSWIRE) -- 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 .

About CIDAL Limited

CIDAL 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  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



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Athenex, Inc.:

Randoll Sze

Chief Financial Officer

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Jacqueline Li

Corporate Development and Investor Relations

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