2014 was a watershed year for Amgen, with four new products submitted for approval and revenues passing the $20bn mark for the first time, according to chief executive Bob Bradway.
Speaking to investors yesterday, Bradway said Amgen is in the midst of a new product launch cycle, including three drugs on course to be launched prior to the end of the year. These are evolocumab for high cholesterol, heart failure drug Corlaner (ivabradine) and talimogene laherparepvec (T-VEC) for melanoma.
The three planned launches come on top of the recent green light for immuno-oncology Blincyto (blinatumomab) for acute lymphoblastic leukaemia (ALL) and a new filing for multiple myeloma therapy Kyprolis (carfilzomib) in patients who have relapsed after just one prior therapy rather than two.
Despite the upbeat comments, Amgen did reveal that Corlaner and T-VEC have both been delayed by requests for additional data by the FDA, with the agency now aiming to deliver its verdict on the applications by May 28 and October 27, respectively.
For the fourth quarter, Amgen reported sales up 6% to $5.33bn – ahead of analyst expectations and buoyed by an 11% increase in sales of flagship immunotherapy Enbrel (etanercept) to $1.34bn – with net profit rising 27% to $1.3bn.
Long-acting white blood cell stimulator Neulasta (pegfilgrastim) grew 7% to $1.1bn, although its short-acting predecessor Neupogen (filgrastim) slumped 11% thanks to competition from biosimilars. Neupogen could come under additional pressure this year with the likely approval of a biosimilar from Sandoz in the US in the next few months.
Amgen’s denosumab franchise – Prolia for osteoporosis and Xgeva for bone metastases in cancer – grew 23% to $640m, while Kyprolis advanced 25% to $91m with sales for the year reaching $331m in the first full-year since Amgen acquired the drug as part of its $10.4bn acquisition of Onyx Pharmaceuticals in 2013.
Bradway also highlighted the approval of a new on-body injector designed to make administration of Neulasta easier, as well as a possible marketing application for hyperparathyroidism therapy velcalcetide (AMG 416) in the coming months and the start of phase III trials of migraine candidate AMG 334.
Amgen is expecting 2015 revenues to be in the $20.8bn to $21.3bn range.