Athenex (ATNX) Announces U.S. Launch of Klisyri and Licensing of Additional Territories for Tirbanibulin

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 that today marks the U.S. launch of Klisyri® (tirbanibulin) in the United States, led by the Company’s partner Almirall. Athenex announced the licensing of additional territories for tirbanibulin to its partner PharmaEssentia Corp. (Taiwan Exchange: 6446). Athenex received approval from the U.S. Food and Drug Administration (FDA) for Klisyri® for the topical treatment of actinic keratosis of the face or scalp on December 14, 2020.

“We are thrilled to announce the U.S. launch of Klisyri® and the expansion of our successful collaboration with PharmaEssentia to now include the Japanese and South Korean markets,” said Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex. “Throughout our partnership, PharmaEssentia has demonstrated strong execution and a commitment to drug research and development. We are confident that this will further our mission to bring a valuable treatment option to benefit patients globally.”

PharmaEssentia (PEC) adds licensing rights to tirbanibulin for Japan and South Korea to already licensed territories, which include Taiwan, Singapore, and Malaysia. Under the expanded agreement, Athenex will receive an upfront payment from PharmaEssentia, and will be eligible to receive milestone payments associated with the achievement of certain development and sales milestones. Athenex will also be eligible to receive tiered double-digit royalties on net sales of tirbanibulin in Japan and South Korea.

Dr. Ko-Chung Lin, Chief Executive Officer of PharmaEssentia, added, “We are delighted by the news of the U.S. FDA approval of Klisyri®. We believe that Klisyri® will disrupt and change the AK treatment paradigm and provide good options for patients in Asia, particularly for those in Taiwan, Japan, Korea, Vietnam, Malaysia and Singapore.”

Klisyri® launched today in the U.S., led by our partner Almirall. Under the terms of the license agreement with Almirall, Athenex is eligible to receive up to $65 million in milestone payments associated with today’s launch and expansion into additional indications. Additionally, Athenex is eligible for additional sales-related milestone payments. The agreement includes tiered royalties starting at 15% based on annual net sales.

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