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Athenex Announces FDA Allowance of Investigational New Drug Application of Eribulin ORA to Begin Clinical Trials

BUFFALO, N.Y., Oct. 29, 2018 (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 and related conditions, announced today that the FDA has allowed the Investigational New Drug (IND) application for Athenex's oral version of Eribulin currently named Eribulin ORA.

This FDA action allows Athenex to commence its clinical trial program, currently planned for first half of 2019.  Eribulin, an effective treatment for metastatic breast cancer and liposarcoma, is currently limited to intravenous administration.  Utilizing Athenex’s proprietary Orascovery platform with Eribulin, we were able to demonstrate that good oral absorption of Eribulin is possible, based on preclinical studies. In addition, the Eribulin active pharmaceutical ingredient (API) has been developed internally using a novel synthetic approach. We believe these developments demonstrate the broad utility of the Orascovery platform and commitment of Athenex to becoming a major global oncology biopharmaceutical company.

Dr. Michael Smolinski, Athenex’s Head of Preclinical Research, commented, “Athenex is delighted that the FDA has allowed the IND of Eribulin ORA.  The demonstration of a favorable pharmacokinetic profile, with lowered peak plasma concentration and longer duration of the drug within the desired plasma concentration range, provides the potential for a better efficacy and an improved safety profile for Eribulin, similar to what we have observed with Oraxol (oral form of paclitaxel) and others. We have also developed a novel and efficient synthetic process for Eribulin with an excellent purity profile. This is the eighth US IND allowance that Athenex has obtained, reflecting the passion and dedication of the company to bringing new therapies to cancer patients.”

Eribulin is an anticancer drug marketed by Eisai Company under the trade name Halaven.  It is used to treat certain patients with breast cancer and liposarcoma. Eribulin is a synthetic derivative of the natural product Halichondrin B.  The potent anticancer effects of this agent come primarily from its unique means of targeting microtubule dynamics, a process critical to cell proliferation. 

Dr. Rudolf Kwan, Athenex’s Chief Medical Officer, stated, “Eribulin is approved for the treatment of metastatic breast cancer patients who have received at least two prior chemotherapy regimens for late-stage disease, including both anthracycline- and taxane-based chemotherapies. It is important to note that Eribulin is active in paclitaxel resistant tumors. This profile is expected to create a number of synergistic opportunities with the other drug candidates in our Orascovery clinical pipeline. We look forward to initiating the Phase I clinical studies soon.”

The lead compound in Athenex’s Orascovery program, Oraxol, is currently in a pivotal Phase III study. The Orascovery platform was developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.

About Athenex, Inc.
Founded in 2003, Athenex, Inc. is a global clinical stage biopharmaceutical company dedicated to becoming a leader in the discovery and development 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 and multiple locations in Chongqing, China. For more information, please visit www.athenex.com.

Forward-Looking Statement
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,” “probable,” “project,” “seek,” “should,” “will,” 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; competition; intellectual property risks; risks relating to doing business in China; 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
Email: jacquelineli@athenex.com

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Athenex, Inc.