Positive Phase III Clinical Results for EirGenix's Proposed Trastuzumab Biosimilar

In a press conference today, EirGenix, Inc. announced that the Phase III clinical trial (Trial No.: EGC002, NCT03433313) of its breast cancer biosimilar, EG12014 (proposed trastuzumab biosimilar, also called EGI014), has met its primary endpoint. EG12014 has shown equivalent efficacy to Herceptin® in regards to its clinical response (pathologic complete response, pCR), in addition to demonstrating a comparable safety profile.  EirGenix will proceed with the preparations for submissions of Biologics License Application (BLA) to the U.S. FDA, Market Approval Application (MAA) to European Medicines Agency (EMA) and New Drug Application to TFDA, exact timings remain confidential.

This phase III clinical trial is a multi-national, multi-center, randomized, double-blinded study involving female with early, HER2-positive breast cancer. The purpose of the trial was to demonstrate the therapeutic equivalence in terms of efficacy between EG12014 to Herceptin®, and to compare the safety, immunogenicity and PK between the two trastuzumab products. A total of 807 enrolled patients were randomly assigned in a 1:1 ratio to one of the two parallel treatment groups and received anthracycline-based chemotherapy every 3 weeks for 12 weeks (cycle 1 to 4). After chemotherapy, patients received EG12014 or Herceptin® in combination with paclitaxel, every 3 weeks for 12 weeks (cycle 5 to 8). All patients were scheduled for tumor removal surgery (breast and axillary lymph nodes) 3 to 6 weeks after completion of neoadjuvant therapy (pre-operative treatment). Two (2) to 6 weeks after surgery, eligible patients continued with trastuzumab therapy in the adjuvant study to complete 12 months of overall trastuzumab treatment (adjuvant cycle 1 to 13), followed by a 20-week long-term safety follow-up (after final dose of trastuzumab).

During tumor removal surgery, samples were collected for assessment of a pathologic complete response (pCR) by an independent central laboratory. The primary endpoint of pCR is defined as absence of invasive cancer in the breast and axillary nodes, irrespective of ductal carcinoma in situ (ypT0/is ypN0). Demonstration of therapeutic equivalence in regards to the pCR between the two treatment groups (EG12014 vs Herceptin®) in the pre-operative treatment setting was based on the pre-specified risk ratio (0.741 – 1.349) and probability difference (-0.13 – 0.13). The topline results demonstrated that EG12014 met equivalence to Herceptin® in terms of clinical response in both analysis populations (per-protocol and full-analysis sets). Additionally, the safety profiles of the two treatment arms were shown to be comparable in the pre-operative treatment setting.

According to Roche's annual report, global sales of Herceptin® totaled 3.73 billion CHF in 2020. The US and EU market are 1.36 billion CHF and 0.67 billion CHF respectively. Herceptin® sales were 34% lower than in 2019, driven by biosimilar competition, which was introduced in the second half of 2019 in the US and mid-2018 in Japan and Europe. Upon approval Sandoz AG, a global leader in generics and biosimilars will sell EG12014 globally in all markets except for Taiwan, China and Mainland China, as per the licensing agreement signed with EirGenix in April 2019. The licensing agreement included a signing fee and milestone payments , and a profit sharing of product sales in the authorized markets after product launch. The revenue from the milestone payments will be recognized in stages in accordance to standard accounting procedures and will serve to benefit the company's current operations and further development. In 2019, Taiwan, China's National Health Insurance (NHI) paid approximately 1.657 billion New Taiwan, China Dollars (NTD) for Herceptin®.

Current demand for complex biological drugs has increased and will continue to rise in the future. With the drug patents of major biological drugs set to expire in the near future, the development of biosimilars has been greatly encouraged within the industry. The demand has been driven by the need for more cost-effective drugs in countries with limited medical resources.  EirGenix is currently the first and only biopharmaceutical company in Taiwan, China to have successfully signed a licensing agreement with a global pharmaceutical company for a biosimilar. EirGenix is also one of only a handful of Taiwan, Chinaese biopharmaceutical companies to have independently developed a biosimilar product into Phase III clinical trials and successfully demonstrating its equivalent efficacy. With such developmental achievements, EirGenix is rightfully worthy of investors' attention and expectations.