Athenex Announces License Agreement with PharmaEssentia for Oradoxel (Oral Formulation of Docetaxel) in Several Areas in Asia

Athenex, Inc., a global biopharmaceutical company dedicated to the research of new therapies for cancer and related diseases, Development and commercialization) announced today that it has reached an agreement with PharmaEssentia Corporation (Taiwan, China Cabinet Buying Center: 6446) to authorize the development and commercialization of Athenex's Oradoxel in Taiwan, China, Singapore and Vietnam. This is an extension of the existing licensing agreement with PharmaEssentia for Oraxol (oral preparation of paclitaxel) and Oratecan (oral preparation of irinotecan), including the milestone payment for Oradoxel (oral formulation of docetaxel). Athenex and PharmaEssentia signed a licensing agreement in December 2013 to authorize PharmaEssentia to develop and commercialize Oraxol and Oratecan in Taiwan, China and Singapore. The agreement was revised in December 2016 to extend the scope of authorization to Vietnam.

Under the terms of the extended agreement containing Oradoxel, Athenex will receive a cash payment and is expected to receive additional milestone payments for a number of development and regulatory milestones in the relevant region by Oradoxel. PharmaEssentia will be responsible for all clinical development, regulatory approval and commercialization activities and related expenses of Oradoxel in the relevant regions.

Docetaxel is an anticancer chemotherapeutic agent widely used in the treatment of breast cancer, prostate cancer, stomach cancer, head and neck cancer and lung cancer. Oradoxel is an oral preparation of Docetaxel in combination with HM30181A, a novel gastrointestinal specific P-glycoprotein pump inhibitor. Oradoxel is currently in Phase I clinical research in the United States and New Zealand and is preparing to enter Phase II clinical studies, which is scheduled to begin in the first half of 2019.

Dr. Kochung Lin, CEO of PharmaEssentia, said: "Athenex's Orascovery drug candidate, especially Oraxol, has been very encouraging in clinical trials. The oral chemotherapeutic drug is expected to greatly improve efficacy and safety and improve patient quality of life. Athenex Both Oratecan and Oradoxel have shown good data in Phase I clinical trials, and we are very pleased to be involved in the development of these products in Taiwan, China, Singapore and Vietnam to help realize the full potential of the platform. We appreciate the execution of the Athenex team. It is a pleasure to reach the cooperation of Oradoxel and continue to deepen and expand our partnership."

Athenex CEO and Chairman Dr. Johnson Lau said: "This agreement is based on our long-standing relationship with PharmaEssentia. PharmaEssentia has been Committed to the development of cancer drugs, we believe that we have the ability to successfully deliver Oradoxel to patients in authorized areas."

The Orascovery platform was originally developed by Hanmi Pharmaceuticals, and Athenex was awarded an exclusive license for the platform in all major regions of the world except South Korea (reserved by Hanmi).

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