EirGenix Inc (台康生技), a contract development and manufacturing organization (CDMO) and biosimilars maker, yesterday said it expects to begin the global phase III trial for its Herceptin (trastuzumab) biosimilar EG12014 in the second quarter of next year at the earliest.
“We have successfully completed four batches of 1,000 liters of EG12014 this year, as part of preparations for the phase III trial,” EirGenix president and CEO Liu Lee-cheng (劉理成) told an investors’ conference.
EirGenix was spun off from the Development Center for Biotechnology in December 2012 and officially registered as a new company in March 2013 with a paid-in capital of NT$540 million (US$17.98 million at the current exchange rate).
The company has two main business units: CDMO and product development, which includes the development of biosimilars, specialty biologics and novel biologics, Liu said.
EirGenix has seven product lines, four of which are biosimilars, he said, adding that the development of EG12014 is progressing faster than the company’s other biosimlars.
After a comprehensive similarity assessment, EG12014 was found to be highly similar to Herceptin at all tested scales, and across all structural and functional tests, Liu said.
Herceptin is used to treat breast or metastatic stomach cancers.
The global phase III trial is to cost between 50 million and 60 million euros (US$58.8 million and US$70.5 million) and is to involve 800 patients in 20 nations, he said.
Due to the sizeable costs of the trial, EirGenix is in talks with five potential strategic partners to share the expense, and to market and sell the product when it is commercialized, he added.
“Two of the five potential partners have entered the critical negotiation stage with EirGenix,” Liu said. “We hope to strike a deal with one of them soon.”
Chang Chih-jung (張志榮), vice president of EirGenix’s CDMO unit, said the company’s CDMO business broke even in the first half of this year and turned profitable last quarter.
Revenue from EirGenix’s overseas clients accounted for nearly 40 percent of the firm’s total revenue in the first three quarters of the year, he said, adding that the company expects the revenue contribution from overseas clients to reach 50 percent next year.
EirGenix estimated that revenue from the CDMO unit would continue to grow by a double-digit percentage next year on the back of newly added clients in China, the US and Europe, Chang said.
The firm’s new plant in Hsinchu County’s Jhubei City (竹北市) is to become operational next year to support the CDMO unit’s growing orders, he added.
The company reported net losses of NT$94.75 million in the first half of the year, compared with net losses of NT$40.08 million in the same period last year, a filing with the Taiwan Stock Exchange showed.
The firm has not yet reported its earnings performance for last quarter.
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