Drug developer PharmaEngine Inc (智擎) yesterday said that it would make a milestone payment of US$1 million to its France-based partner Nanobiotix SA as its new medical device for treating soft tissue sarcoma is about to enter pivotal trials by the end of this year.
“The device is expected to enter the European and Asian markets by the end of 2016 after completing the pivotal trials and acquiring subsequent legal approval,” PharmaEngine director Peter Wu (吳兆升) said by telephone.
Nanobiotix will start recruiting patients in Europe for the device — PEP503 (NBTXR3) — by the end of this year, while PharmaEngine will conduct the trials in Asia, Wu said.
PharmaEngine is prepared to spend US$450,000 to recruit 30 patients in Asia.
After the completion of the trials in Asia, PharmaEngine will license the device to other companies or sell the right to sell the device in Asia to Nanobiotix, he said.
About 60 percent of cancer patients receive radio therapies, and PharmaEngine expects 15 percent of these patients to use the device, he said.
Europe accounts for about 40 percent of the global total of cancer patients, while Asia — including China and Japan — makes up 30 percent, he said.
Nanobiotix last week established a division in the US, which accounts for about 35 percent of the world cancer population, and the company will seek local partners to conduct pivotal trials for the device in the country, Wu said.
PharmaEngine acquired the right to sell the device in Asia from Nanobiotix in 2012, and Nanobiotix completed the pilot study of the device in France in June.
The company reported revenue of NT$223.31 million (US$7.34 million) from January through last month, up more than seven times from NT$26.9 million the previous year, bolstered by NT$211.65 million in licensing income, according to a company filing with the Taiwan Stock Exchange.
In the first half of this year, the company posted losses of NT$37.45 million, or NT$0.37 per share, compared with the year-earlier level of losses of NT$27.32 million, or NT$0.3 per share, the filing showed.
PharmaEngine’s shares declined 2.94 percent to NT$264 yesterday, underperforming the TAIEX, which was down 0.95 percent.
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