Sinphar Group (杏輝醫藥集團) yesterday said that a moment of truth is coming for its decade-long venture into new drug development, with a global phase III clinical trial to commence next year.
SynCore Biotechnology Co (杏國), which is overseeing the development of Sinphar’s pancreatic cancer drug SB05, said that it expects to finish enrolling 218 people required for the trial, which has been approved by seven countries.
Toward the end of the first half of next year, the mortality rate among those participating in the trial is expected to reach the threshold to conduct an interim analysis, SynCore general manager Su Muh-hwan (蘇慕寰) said at an earnings conference in Taipei.
The outcome of the interim analysis would be pivotal to gauge the success of SB05, as well as to gain regulatory approval and for global commercialization, Su said.
If all goes well, SB05 could be launched in 2021 to tap into the global market for pancreatic cancer treatments, worth as much as US$13 billion, Su said, citing findings by Florida-based consulting firm Market Research Engine.
Su said that a Taiwanese patient was the first to enrol in the phase III trial.
Since its founding in 2008, SynCore’s development costs have been a burden for its parent company, Sinphar Group chairman Tim Lee (李志文) said.
While Sinphar Pharmaceuticals Co Ltd (杏輝), the group’s biggest subsidiary, has been generating sufficient profits to sustain the development of new drugs, the parent’s profitability has suffered in the past few years, with earnings per share falling from NT$1.6 in 2013 to NT$0.2 at the end of last year.
The clinical trial is expected to cost the company at least US$20 million for support services provided by contract research organizations, Lee said.
“By next year, we would know whether the student has graduated, or flunked,” Lee said, referring to SynCore.
“Sinphar Group would either see a tremendous new revenue stream, or a significant drop in its costs,” he said.
The group is also counting on other revenue drivers next year, Lee said, adding that investments in automation and advanced manufacturing would begin to pay off.
Sinphar Pharmaceuticals expects to see additional income from its contract manufacturing business next year, with two new cancer drugs to be released in Taiwan, Lee said.
Sinphar Pharmaceuticals is also undergoing manufacturing assessments by authorities in Indonesia and the Philippines to gain access to those markets, he said.
The company would also continue to expand factory tours with its pharmacy chain unit to bolster brand loyalty and awareness, he said.
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