TaiMed Biologics Inc (中裕新藥) yesterday said that it plans to market its Trogarzo HIV treatment in Germany by the end of this year, expressing confidence that it would obtain marketing approval from European regulators in October.
The European Medicines Agency’s (EMA) human medicines committee had a positive opinion on Trogarzo at a meeting on Friday last week, TaiMed chief financial officer Jack Chen (陳怡成) said.
That is important for TaiMed’s business in Europe, as the European Commission takes the committee’s recommendation into account when deciding on marketing approval for new treatments, Chen said.
“If everything goes smoothly, it is likely that we will receive marketing approval in early October,” Chen said.
TaiMed and its business partner, Canada-based Theratechnologies Inc, have decided that Germany would be Trogarzo’s first European market, he said.
Germany has a high income per capita and its regulations on drug prices are more friendly to pharmaceutical companies, he said.
Drug companies there can market their products before wholesale prices are finalized by the regulator, unlike other European markets, he added.
The price of Trogarzo is set at US$118,000 for a year of treatment in the US, but it is expected to fall by 25 to 35 percent in European markets, Chen said.
Theratechnologies, which helps sell Trogarzo in the US, would be responsible for negotiating the price with local regulatory bodies in Europe, he said.
As TaiMed did not conduct any clinical trials in Europe and used the data generated from its trials in the US for the European review, it is required by EMA to establish a mechanism to monitor local patients and to collect data, Chen said.
TaiMed has seen US sales of Trogarzo rise since the US Food and Drug Administration approved the treatment in March last year, he said.
The company posted cumulative revenue of NT$283 million (US$9.1 million) in the first half of this year, up 638 percent year-on-year, thanks to the rising sales of Trogarzo in the US, Chen said.
European sales are expected to boost whole-year revenue to about NT$800 million, he added.
Contract manufacturer WuXi Biologics Co (無錫生物製藥) would be responsible for the production of Trogarzo for European markets, as TaiMed’s new contract manufacturing partner Samsung BioLogics Co’s new plant in Hsinchu County’s Jhubei City (竹北) is still preparing for production, Chen said.
In the US clinical trial, Trogarzo was proven to have a long-lasting impact on HIV-1, with 83 percent of patients reducing their HIV-1 viral load after receiving a single dose of the drug, the company said.
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