In a press conference today, EirGenix, Inc. (6589.TT) 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(R) 
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(R), 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(R) 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(R)) 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(R) totaled 3.73 
billion CHF in 2020. The US and EU market are 1.36 billion CHF and 0.67 billion 
CHF respectively. Herceptin(R) 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 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's National Health Insurance (NHI) paid approximately 1.657 billion 
New Taiwan Dollars (NTD) for Herceptin(R). 

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 to have 
successfully signed a licensing agreement with a global pharmaceutical company 
for a biosimilar. EirGenix is also one of only a handful of Taiwanese 
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.

SOURCE  EirGenix, Inc.