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.
Hon Hai Precision Industry Co (鴻海精密) yesterday said that its research institute has launched its first advanced artificial intelligence (AI) large language model (LLM) using traditional Chinese, with technology assistance from Nvidia Corp. Hon Hai, also known as Foxconn Technology Group (富士康科技集團), said the LLM, FoxBrain, is expected to improve its data analysis capabilities for smart manufacturing, and electric vehicle and smart city development. An LLM is a type of AI trained on vast amounts of text data and uses deep learning techniques, particularly neural networks, to process and generate language. They are essential for building and improving AI-powered servers. Nvidia provided assistance
STILL HOPEFUL: Delayed payment of NT$5.35 billion from an Indian server client sent its earnings plunging last year, but the firm expects a gradual pickup ahead Asustek Computer Inc (華碩), the world’s No. 5 PC vendor, yesterday reported an 87 percent slump in net profit for last year, dragged by a massive overdue payment from an Indian cloud service provider. The Indian customer has delayed payment totaling NT$5.35 billion (US$162.7 million), Asustek chief financial officer Nick Wu (吳長榮) told an online earnings conference. Asustek shipped servers to India between April and June last year. The customer told Asustek that it is launching multiple fundraising projects and expected to repay the debt in the short term, Wu said. The Indian customer accounted for less than 10 percent to Asustek’s
‘DECENT RESULTS’: The company said it is confident thanks to an improving world economy and uptakes in new wireless and AI technologies, despite US uncertainty Pegatron Corp (和碩) yesterday said it plans to build a new server manufacturing factory in the US this year to address US President Donald Trump’s new tariff policy. That would be the second server production base for Pegatron in addition to the existing facilities in Taoyuan, the iPhone assembler said. Servers are one of the new businesses Pegatron has explored in recent years to develop a more balanced product lineup. “We aim to provide our services from a location in the vicinity of our customers,” Pegatron president and chief executive officer Gary Cheng (鄭光治) told an online earnings conference yesterday. “We
LEAK SOURCE? There would be concern over the possibility of tech leaks if TSMC were to form a joint venture to operate Intel’s factories, an analyst said Taiwan Semiconductor Manufacturing Co (TSMC, 台積電) yesterday stayed mum after a report said that the chipmaker has pitched chip designers Nvidia Corp, Advanced Micro Devices Inc and Broadcom Inc about taking a stake in a joint venture to operate Intel Corp’s factories. Industry sources told the Central News Agency (CNA) that the possibility of TSMC proposing to operate Intel’s wafer fabs is low, as the Taiwanese chipmaker has always focused on its core business. There is also concern over possible technology leaks if TSMC were to form a joint venture to operate Intel’s factories, Concord Securities Co (康和證券) analyst Kerry Huang (黃志祺)
RSS