Amgen’s shares closed up 3.1% at $46.12 last night and continued to climb in after-hours trading as investors brushed off the firm’s disappointing outlook for 2008 and focused on news that its osteoporosis drug outperformed Fosamax in a Phase III study.

Denosumab is the first fully human monoclonal antibody in late-stage clinical development that specifically targets RANK Ligand, a crucial mediator of the cells that break down bone, and is being studied in a range of bone loss conditions including postmenopausal osteoporosis, rheumatoid arthritis and cancer treatment-induced bone loss.

This particular head-to-head, double-blind study looked at the effects of twice-yearly subcutaneous injections of denosumab compared to weekly oral doses of Merck & Co’s Fosamax (alendronate) on bone mineral density in postmenopausal women.

The results showed that the magnitude of improvement in the hip was around 40% greater in the denosumab group compared to those taking Fosamax, a significant finding given Merck’s drug currently pulls in sales of around $3 billion a year.

Q4 sales beat expectations
Meanwhile, Amgen reported higher-than expected fourth-quarter sales of its flagship drugs and managed to generate a small growth in profit despite it having been a rather tough year for the firm, during which it was shaken by regulatory and reimbursement changes that shaved sales of its anaemia drugs Epogen (epoetin alfa) and Aranesp (darbepoetin alfa).

The group turned in net earnings of $835 million, or $0.76 cents per share, compared with a profit of $833 million, or $0.71 per share, for the fourth quarter of 2006.

Sales for the period were down 2% at $3.7 billion, after a 17% jump in international sales was dragged down by a 7% fall in US sales to $2.9 billion, primarily due the continued demise of its anaemia drug franchise. Worldwide sales of Aranesp dropped 25% to $827 million as turnover in the US plummeted nearly 40% to $462 million, on lower market demand. Worldwide sales of Epogen fell 3% $638 million.

On the flip side, combined worldwide turnover of its white blood cell stimulators Neulasta (pegfilgrastim) and Neupogen (filgrastim) climbed 9% to $1.1 billion, North American sales of the anti-inflammatory Enbrel (etanercept) rose 8% to $856 million, and global revenues for Sensipar (cinacalcet), for the treatment of secondary hyperparathyroidism in dialysis patients, leapt 31% to $128 million.

‘Challenging’ year
For the full year, Amgen booked revenues of $14.8 billion, marking growth of 4% over 2006, while earnings grew 7% to $3.2 billion, or $2.82 a share.

“2007 was Amgen's most challenging year,” commented Kevin Sharer, chairman and chief executive of the group, but he remained upbeat about the group’s performance and business potential in the coming year. "Despite the unexpected reduction in revenues of our erythropoietin products, we delivered earnings per share very close to the low end of our original guidance. 2008 presents challenges and opportunities and while we are optimistic, we are ready for whatever might come our way,” he concluded.

The firm said it expects earnings this year of $4.00-$4.30 per share, excluding special items, on sales of $14.2-$14.6 billion, falling under general expectations of around $4.35 a share and $14.5 billion, respectively, according to media reports.