BIOLOGICS LICENSE APPLICATION (BLA) SUBMITTED TO U.S FDA FOR EIRGENIX'S TRASTUZUMAB BIOSIMILAR

[Taipei, Taiwan] – EirGenix, Inc. (6589.TT), announced today that its exclusive global (excluding Taiwan and Mainland China) marketing partner, Sandoz AG, of their Her2 positive breast cancer drug EG12014 (proposed trastuzumab biosimilar, also called EGI014) submitted the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). With that U.S. FDA will now begin its audit of the BLA documents. Subsequent submissions to health authorities in other countries will proceed on schedule, including the submission to Taiwan's Food and Drug Administration under the Ministry of Health and Welfare and European Medicines Agency (EMA). Earlier this year on March 23rd, it was announced that the Phase III clinical trial (Trial No.: EGC002, NCT03433313) of EG12014 had met its primary endpoint. The analyzed results indicated that EG12014 had shown equivalent efficacy to the originator drug Herceptin® regarding its clinical response (pathologic complete response, pCR), in addition to demonstrating a comparable safety profile.  

According to Roche's annual report, global sales of Herceptin® totaled 3.73 billion CHF in 2020. The U.S. and EU market are 1.36 billion CHF and 0.67 billion CHF respectively. Herceptin® sales were 34% lower than in 2019, which was driven by biosimilar competition. Biosimilars allowed continued increases of clinical users of trastuzumab around the world. Upon approval Sandoz AG, a global leader in generics and biosimilars, is entitled to sell EG12014 in all markets except for Taiwan and Mainland China, as per the licensing agreement signed with EirGenix in April 2019. The licensing agreement authorizes EirGenix to maintain the manufacturing rights to EG12014 and authorizes EirGenix to a signing fee, 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 with 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®, ranking 9th in the top 10 drugs purchased by NHI. After the application to U.S. FDA has been reviewed, EirGenix will proceed with application for market authorization in Taiwan and make preparations for product launch and market sales.
 
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 most cost-effective drugs in countries with limited medical resources. In the U.S. and European markets along, the market share for biosimilars have increased 40% year-by-year. The efficacy and safety of approved biosimilars by highly regulated regulatory agencies have been proven countless times through analytical and preclinical data and in international clinical trials over the years, further affirming the benefits and value of developing biosimilars. EirGenix is currently one of the first biopharmaceutical companies in Taiwan to have successfully signed a licensing agreement with a global pharmaceutical company for a biosimilar in active development. 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 submitted BLA to U.S. FDA. With such developmental achievements, EirGenix is rightfully worthy of investors' attention and expectations.