Amgen Inc yesterday launched a Taiwanese affiliate to oversee the marketing of three new drugs that the US-based biotechnology giant has reacquired from GlaxoSmithKline PLC.
The company in December last year reacquired rights to three of its medicines from GlaxoSmithKline in 48 markets and the new affiliate, Amgen Taiwan (台灣安進藥品), has submitted marketing authorization transfer applications to the Food and Drug Administration.
The three drugs are comprised of two types of denosumab injections, Prolia and Xgeva, and Vectibix, an monoclonal antibody injection.
“At the time, the arrangement with GlaxoSmithKline made sense for both parties. However, once Amgen has established a foothold in Asia, the company is aiming to increase its global presence significantly,” Amgen Asia regional corporate communications director Mary Klem said.
Klem said that in addition to marketing, Amgen Taiwan is among the company’s five fully-fledged affiliates in Asia.
Amgen Taiwan’s priorities are to continue investing in clinical trials and promote its parent company’s products in the local market, bringing additional treatments for cardiovascular diseases, as well as oncology and biosimilar medicines, to the local market, Klem said.
GlaxoSmithKline held selected regional rights to the three products since 2010 and generated approximately US$111 million in combined sales from those licenses in 2014, Amgen data showed.
In the five-year period leading up to the launch of its Taiwanese affiliate, Amgen has invested about NT$120 million (US$3.68 million) in clinical trials in Taiwan, Amgen Taiwan general manager Kelvin Chen (陳光冠) said.
Although Chen did not rule out the possibility of local contractors manufacturing Amgen’s products, he said that option is not likely as the US-based company has ample capacity overseas.
“Several studies have taken place in Taiwan and more than 10 studies are ongoing, with more than 200 patients enrolled in clinical trials,” Chen said.
Amgen Taiwan has about 50 employees, Chen said.
Amgen Taiwan has also retained Lin Fu-kuen (林福坤) as a consultant. Lin played an instrumental role in isolating and then cloning erythropoietin, the principal hormone regulating red blood cell production.
Lin’s discoveries led to the commercialization of Amgen’s Epogen, which is used to treat a lower than normal number of red blood cells caused by chronic kidney disease in patients on dialysis.
Prolia is a treatment for osteoporosis for postmenopausal women at a high risk of bone fractures who are intolerant of other forms of osteoporosis therapy.
Xgeva prevents skeletal-related events in patients with bone metastases from solid tumors, such as radiation of the bones, pathologic fractures and spinal cord compression.
Vectibix is used in combination with chemotherapy as a first-line treatment of metastatic colorectal cancer.
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