EirGenix Completes Neoadjuvant Treatment and Surgery for Last Patient in Phase III Clinical Trial

[Taipei, Taiwan] – For the Phase III clinical trial of its breast cancer drug EG12014 (Trastuzumab biosimilar, also called EGI014), EirGenix, Inc. (6589.TT) has completed neoadjuvant treatment and surgery of its last patient. Following analysis of the main efficacy data (pathological complete response [pCR] at the time of surgery) for all patients in the Phase III clinical trial, EG12014 will be compared with the originator drug (Roche’s Herceptin®) to confirm bioequivalence. 

Earlier this year on March 25th, 2020, the last patient was randomized of its 807-patient, multi-national phase III clinical trial for EG12014/EGI014 (Trial No.: EGC002).

In April 2019, EirGenix signed a global licensing agreement with Sandoz AG, a global leader in generics and biosimilars. The licensing agreement authorized Sandoz AG to the exclusive commercial rights to EirGenix’s EG12014 (Trastuzumab biosimilar, also called EGI014) in all markets except mainland China and Taiwan. The licensing agreement includes a signing fee and milestone payments valued at a total of US$ 70 million, and additional royalty payment in the authorized markets after product launch. The signing fee of US$ 5 million was already received by EirGenix in June 2019.  In addition, EirGenix has fulfilled the first, second and third milestones of its licensing agreement with Sandoz AG.  The revenue from the milestone payment will be recognized in stages in accordance with standard accounting procedures and will serve to benefit the company’s current operations and further development. 

EirGenix is currently the first and only biopharmaceutical company in Taiwan to have successfully signed a licensing agreement with a global pharmaceutical company for a biosimilar in active development, while also retaining responsibility for production and rights to profit-sharing on sales in the territories. The collaboration between EirGenix and Sandoz AG leverages the combined strength of EirGenix’s biosimilar medicine R&D and manufacturing capabilities together with Sandoz AG’s substantial experience in global commercialization and market access capabilities. With such a positive outlook EirGenix hopes to fully meet its investors’ expectations.