Mon, Apr 08, 2019 - Page 16 News List

PharmaEngine partner gains European approval

By Chen Cheng-hui  /  Staff reporter

Drug developer PharmaEngine Inc (智擎生技) said its French partner Nanobiotix SA has received European market approval for PEP503 (NBTXR3), enabling commercialization of the nanoparticle radio-enhancer in the EU for the treatment of locally advanced soft-tissue sarcoma.

PEP503 would be marketed in the 27 EU countries under the brand name Hensify, PharmaEngine said in a filing with the Taiwan Stock Exchange on Saturday.

PharmaEngine in August 2012 acquired the exclusive rights from Nanobiotix to develop and commercialize PEP503 in the Asia-Pacific region.

PharmaEngine might be able to license the treatment to other companies in the region in the near term, the Chinese-language Commercial Times reported yesterday, adding that royalty revenue from sales could start from US$200 million.

PEP503 is a nanoparticle formulation of crystalline hafnium oxide that was designed to enhance the efficacy of radiotherapy for cancer treatment, the company said.

In addition to the treatment of soft-tissue sarcoma, PEP503 is being evaluated for other cancer types, such as head-and-neck cancer, liver cancer, rectal cancer and prostate cancer, PharmaEngine said.

In the US, the treatment has gained approval for a clinical trial in combination with anti-PD-1 immunotherapies for patients of non-small-cell lung cancer and head-and-neck cancer, the company said.

PharmaEngine reported cumulative revenue of NT$61.04 million (US$1.98 million) for the first two months of the year, up 96.29 percent from NT$31.1 million the previous year, a company regulatory filing showed.

The surge in revenue was mainly due to contributions from its pancreatic cancer drug, Onivyde, which has received reimbursements of NT$26,400 per vial from the National Health Insurance Administration since August last year.

The company posted net profit of NT$129.36 million for last year, or NT$0.88 in earnings per share, compared with the year-earlier level of NT$387.06 million, or NT$2.62 per share.

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