On December 16, 2019 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer, reported that it has expanded its strategic partnership with Chinese drug company, Guangzhou Xiangxue Pharmaceutical Co., Ltd. ("Xiangxue"), to exclusively develop and commercialize Athenex’s oncology product candidates Oral Paclitaxel (both the capsule and the tablet formulations), Oral Irinotecan, as well as Tirbanibulin (KX2-391, also known as KX-01) Ointment, including for the treatment of actinic keratosis (AK) in the Territory (Press release, Athenex, DEC 16, 2019, View Source [SID1234552384]).
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Under the terms of the license agreement, subject to the satisfaction of certain conditions, Athenex will receive an upfront payment of $30 million. Athenex will also be eligible to receive development, sales and other milestone payments up to $170 million, and tiered royalties ranging from the sub-teen to low twenties based on annual net sales of licensed products in the Territory and a percentage of sublicensing revenue. The total deal size is potentially $200 million, excluding the royalty payments.
The agreement provides for joint decision making through a Joint Steering Committee with respect to the development and commercialization of the licensed products in the Territory. Athenex and Xiangxue will jointly lead the clinical development programs with Athenex to coordinate the global drug development efforts while Xiangxue will oversee commercialization activities in the Territory.
Mr. YongHui Wang, Chairman and CEO of Xiangxue, said, "We are thrilled about this strategic partnership extension with Athenex in China which complements our successful collaboration on KX2-361 (also known as KX-02) for brain tumors (including glioblastoma multiforme) and TCR-T immunotherapy. Our collaboration has been highly rewarding, and we have also witnessed Athenex’s strong execution track record, in terms of research and development as well as business expansion. The oral paclitaxel and encequidar data are extremely exciting, with clear benefits on tumor response, improved survival and less neuropathy. We believe the results pave the way for oral irinotecan to follow its success. The promising tirbanibulin data have also shown significant clinical benefits to patients with AK in two randomized, controlled
clinical studies. Our assessment is that there is compelling market potential for oral paclitaxel and encequidar in China, and that tirbanibulin ointment will address an underserved market in AK."
"This extended strategic partnership, together with KX2-361, expands our novel drug portfolio into a strong pipeline consisting of two Phase 3 product candidates with positive clinical trial results, one product candidate with proof-of-concept data that is ready to advance to Phase 2, and one Phase 1 product candidate," continued Mr. YongHui Wang. "We expect the partnership will enable us to lead these innovative therapies into commercialization and position us to further tap into one of the largest and most promising healthcare markets worldwide. We will be expanding our marketing and sales capacity to allow us to maximize the potential of these exciting opportunities."
Dr. Johnson Lau, Chief Executive Officer and Chairman of Athenex, stated, "We are pleased with the extension on the strategic partnership with Xiangxue, and their confidence in our clinical data. We believe this serves as an important validation of our science and product portfolio. We have selected Xiangxue as our partner based on our long term productive collaboration, and because their commitment to develop this portfolio is aligned with our global strategy. Xiangxue also plans to expand its marketing and sales infrastructure to focus on China to capture the full potential of these products. We look forward to leading the global clinical development of these advanced clinical stage products with the ultimate goals of serving patients and addressing the attractive market opportunities that exist in China."
The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.
Athenex has an exclusive license agreement with Almirall, S.A. to the rights to tirbanibulin ointment in the following territories: USA, European Union, Russia and Turkey. Details of this arrangement were disclosed in December 2017.