PR88594

TAIPEI, March 23, 2021 /PRNewswire=KYODO JBN/ --

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.