Amgen ($AMGN) said that the approval for Repatha (evolocumab) in Japan, filed by Amgen Astellas Biopharma K.K., a joint venture with Tokyo-based Astellas Pharma, could be launched within months pending reimbursement details.
In Japan, Repatha is indicated for patients with familial hypercholesterolemia or hypercholesterolemia with a high risk of cardiovascular events. The move expands Amgen's geographical reach outside of the United States, Europe and Canada, said Bob Bradway, chairman and CEO, on the Jan. 28 earnings call, adding that this was "our first product approval for this Japanese partnership."
It was also the first approval of a PCSK-9 inhibitor in Japan.
|Amgen's Tony Hooper|
Tony Hooper, executive vice president for global commercial operations, said the timetable to launch was within sight as it gets assessed on pricing by Japan's Central Social Insurance Medical Council, known as Chuikyo.
"Along with our partner Astellas, we are looking forward to launching the product in the next few months after securing reimbursement," he said.
Hooper went on to say that overall the company, like its peers, took a hit on foreign exchange.
"Foreign exchange negatively impacted year-over-year sales by two percentage points in both the fourth quarter and the full year," Hooper said on the call, adding that further expansion into new countries was also linked to cost savings, including a plant to come online this year in Singapore.
"In manufacturing, our teams are significant contributors to our transformation efforts, driving down our cost of sales and making final preparations for the licensure of our next generation bio manufacturing facility in Singapore," Hooper said.
- here's the release