Wed, May 03, 2017 - Page 12 News List

Trials of cancer drug a success, EirGenix says

By Ted Chen  /  Staff reporter

EirGenix Inc (台康生技) yesterday said that the phase I clinical trial conducted on its new biosimilar drug, codenamed EG12014, for treating breast cancer and stomach cancer was a success.

The outcome paves the way for new opportunities for lower-priced biosimilar drugs as patents on mainstream oncology drugs approach their expiration dates in the next few years, EirGenix said.

A biosimilar drug is a near-identical copy of an original biologic medical product that can be manufactured by a different company following the expiration of the original product’s patent.

EG12014 is a biosimilar of trastuzumab, a monoclonal antibody sold by Swiss pharmaceutical giant Roche under the brand name Herceptin.

The study, which was conducted in Europe on 84 healthy males, showed that EG12014 had met its primary endpoint of producing a pharmacokinetics profile that is comparable to Herceptin, the company said.

Due to the precedents set in the approval of Herceptin, European regulators do not require the company to conduct a phase II study, the company said.

The company said that it has begun preparations for a phase III trial and that it is expecting to submit drug license reviews to regulators in the US and Europe in about two years, a filing with the Taiwan Stock Exchange said.

The upcoming phase III trial would be conducted in the US and 19 European nations, the company said, adding that it is aiming to enroll 800 early-stage breast cancer patients.

The company said that last year Herceptin contributed sales of 6.78 billion Swiss francs (US$6.8 billion) for Roche, according to the Swiss company’s annual report.

EirGenix reported a net loss of NT$112.41 million (US$3.74 million) last year, translating to a loss per share of NT$1.15.

That was an improvement from a net loss of NT$134.58 million, or a loss per share of NT$1.69, in 2015.

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