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Under the realignment,
a) Orascovery Program – Extension of Athenex’s territories to worldwide apart from Korea. In previous agreements,
Athenexin-licensed the rights of the Orascovery Program from Hanmi Pharmaceuticalfor the US, Europe, Latin America, Japan, Chinaand the rest of Asia(apart from Korea). The revised agreement will also provide Athenexwith rights to the Middle Eastand North Africa(“MENA”) as well as South Africa. Given the excellent progress that has been made in the various clinical programs, Athenexand Hanmi Pharmaceuticalbelieve that global development of the Orascovery Program under Athenexwill result in more rapid advancement of the clinical and regulatory process across the globe. Hanmi Pharmaceutical, as a leader of the pharmaceutical industry in Korea, will continue to oversee the development and regulatory efforts in Korea.
b) KX-01 Oral Formulation –
Athenexwill receive back from Hanmi Pharmaceuticalthe rights to KX-01 Oral Formulation for Korea, Chinaand other Asian territories. As recently announced, KX-01 Ointment (KX2-391) was shown to be effective and safe for actinic keratosis (AK) in two Phase 3 clinical studies conducted in the US, with both studies having met their primary endpoint of 100% clearance of AK lesions at Day 57 within the treatment areas, with statistical significance (p<0.0001). The arrangement will allow Athenexto explore the potential of KX-01 Oral Formulation globally.
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. Athenex’s Oncology Innovation Platform generates clinical candidates through an extensive understanding of kinases, including novel binding sites and human absorption biology, as well as through the application of Athenex’s proprietary research and selection processes in the lab. 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) metabolic manipulation of cancer. The Orascovery platform is based on the novel oral P-glycoprotein pump inhibitor molecule HM30181A, which is able to facilitate oral absorption of traditional cytotoxics, which Athenex believes may offer improved patient tolerability and efficacy as compared to IV administration of the same cytotoxics. 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. The Src Kinase Inhibition platform refers to novel small molecule compounds that have multiple mechanisms of action, including the inhibition of the activity of Src Kinase and the inhibition of tubulin polymerization during cell division. The TCR-T platform is a cancer immunotherapy platform originally developed by Xiangxue Life Sciences. Athenex has established and is leading a Joint Venture with Xiangxue Life Sciences that owns the global rights to this program, apart from China. The metabolic manipulation of cancer was through depletion of circulating arginine, an amino acid that can be made by normal cells but not by a significant proportion of cancer through interruption of their urea cycle, a pathway essential for the synthesis of arginine, and thereby starving the cancer cells with interrupted urea cycle. Athenex believes the combination of these mechanisms of action provides a broader range of anti-cancer activity as compared to either mechanism of action alone. 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,
Managing Director, LifeSci Advisors, LLC
Tel: +1 212-915-2564