Medigen Biotechnology Corp (基亞) on Monday said an interim study of its new liver cancer drug did not yield positive results.
The results would delay regulatory approval for the firm’s leading product candidate and cast a shadow on its profitability this year.
Medigen shares extended their slide for a second day, closing at NT$379 yesterday in Taipei trading.
In the interim analysis, researchers discovered that the disease-free survival of PI-88 was no better than a placebo, although there is no safety concern over the treatment, the company said in a filing with the Taiwan Stock Exchange.
US-based BioClinica Inc would conduct a further study to verify the interim study results, with the data likely to come out next month or in September, Medigen said.
Yesterday, Medigen said it has decided to continue the phase-three trials, which involve the application of the PI-88 treatment on the remaining 40 percent of all test subjects recruited over the past year.
The move is expected to increase the company’s operating expenditure by NT$100 million, Medigen said.
From 2012 through this month, the company had recruited 520 people for the clinical trials, with 140 reporting cancer recurrence.
“The results are lower than market expectation,” SinoPac Securities Investment Service Corp (永豐投顧) analyst Fion Chen (陳奕均) said in a research note on Monday.
“Medigen either has to announce the failure of its clinical trials once and for all, or to wait for the overall results of the phase three trials set to come in about two to three years from now,” she said.
With the effectiveness of PI-88 cast in doubt, SinoPac downgraded its investment recommendation on the company’s shares to “neutral” from “buy.”
The brokerage also forecast Medigen would post losses of NT$350,000 (US$11,700), or NT$0.26 per share, this year. Last month, SinoPac predicted Medigen this year would post a net profit of NT$400,000, or NT$0.3 per share.
From January through last month, Medigen registered revenue of NT$177.88 million, up 3.4 times from NT$40.32 million a year ago.
SinoPac said revenue for the whole of this year is likely to total NT$370 million, up 4.07 times from NT$73.01 million last year.
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