Amgen has presented top-line data from a Phase III study in heart failure patients which shows that its anaemia blockbuster Aranesp failed to meet its primary endpoints.
Specifically, the trial, which began in 2006, involved 2,278 systolic heart failure patients with anaemia who received either Aranesp (darbepoetin alfa) or placebo. Amgen noted that its drug did not reduce the composite endpoint of time to death from any cause or first hospital admission for worsening heart failure. Full results will be presented at an upcoming medical meeting.
There were no new safety findings identified in the study, the US biotech major noted. The most frequently reported adverse events in the study included cardiac failure, diarrhoea, congestive heart failure and dizziness.
Aranesp, which is approved for treating anaemia in kidney disease patients and some cancer sufferers, is a big earner for Amgen, and sales of the drug in the third quarter of 2012 came in at $497 million. However that was down 17% and revenues have beeb declining over the last couple of years, due to reimbursement problems and label changes, restricting its use.
Last month, Amgen admitted conducting illegal marketing practices to promote the drug in the USA, agreeing to pay more than $760 million in fines and the resolution of various whistleblower lawsuits.
$200 million for Singapore plant
Meantime, Amgen has unveiled plans to construct a new manufacturing plant in Singapore, its first such facility in Asia.
The biotech will pump $200 million into the plant, in the Tuas Biomedical Park area of Singapore, over the next several years. It will initially focus on expanding Amgen’s manufacturing capability for monoclonal antibodies.
Madhu Balachandran, head of operations at Amgen, said the new facility forms "part of our global expansion strategy", adding that Singapore is "an ideal location to further our manufacturing efforts based on its rich talent pool and friendly business environment".
Construction is expected to begin in the next few months, and Amgen is currently partnering with local universities to recruit for a number of positions in manufacturing and quality.