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New Bone Therapy Denosumab vs Fosamax
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Amgen says denosumab vs Fosamax trial meets goals
LOS ANGELES, Jan 24 (Reuters) - Amgen Inc (AMGN.O: Quote, Profile, Research) said on Thursday that a head-to-head trial comparing its experimental osteoporosis drug denosumab to Merck & Co Inc's (MRK.N: Quote, Profile, Research) Fosamax in post-menopausal women with low bone mineral density met all of its goals.
Amgen said the one-year study involving just over 1,000 patients showed that the relative magnitude of bone mineral density improvement at the hip was about 40 percent greater in patients injected with denosumab, compared with the group treated with oral Fosamax.
The company also said the study showed similar side effects, including infection rates, for both arms of the trial.
"The rate of serious adverse events was completely balanced," said Roger Perlmutter, head of research and development at Thousand Oaks, California-based Amgen.
The results are seen as key to denosumab's market potential, since lower-priced generic versions of Fosamax, also known as alendronate, are expected to be available before the Amgen drug is launched.
Still, data from a pivotal-stage trial designed to measure the ability of denosumab to reduce bone fractures is not expected until the second half of this year.
"We would expect a lot more safety information from that trial," which is a three-year study involving around 8,000 patients, Perlmutter said.
Pharmatimes.com
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.
Amgen sees its sales dip amid FDA scrutiny
By Christopher Bowe in New York
http://www.ft.com
Published: January 25 2008 02:34 | Last updated: January 25 2008 02:34
Amgen, the US biotechnology drugmaker, revealed the continuing fallout from Food and Drug Administration scrutiny of its crucial anti-anaemia treatments as fourth-quarter net income rose only slightly while sales fell.
The once fast-growing group said fourth-quarter profits, excluding restructuring items, increased 3 per cent to $1.1bn, or $1 per share, exceeding Wall Street expectations.
But its revenues fell 2 per cent in the quarter to $3.74bn, due to plunging sales of Aranesp and Epogen, its most important products.
Amgen was forced to restructure last year as questions over the safety of these anti-anaemia treatments caused a reassessment on how they, and similar products by Johnson & Johnson and Roche, should be used.
But Amgen also provided a glimmer of hope for the future with favourable data on its most important pipeline drug, Denosumab.
The experimental osteoporosis drug helped improve bone mineral density 40 per cent better than Fosamax, which is a commonly used treatment by Merck of the US.
Shares of Amgen were trading 5 per cent higher at $48.45 in after-hours trading in New York.
Kevin Sharer, chief executive, said that although 2007 was Amgen's "most challenging" year, it illustrated the company's size and financial flexibility to offset significant problems.
Mr Sharer said: "I am also encouraged by our recent Denosumab trial results and the potential of our pipeline. 2008 presents challenges and opportunities and, while we are optimistic, we are ready for whatever might come our way."
Amgen's outlook for this year remained cautious. It expects earnings, excluding items, to remain flat at best or fall up to 7 per cent at worst.
The group forecast earnings this year to fall to a range of $4 to $4.30 per share.
Last year, Amgen profits increased 4 per cent to $4.8bn while earnings per share increased 10 per cent to $4.29.
The group expects sales this year also to fall slightly to $14.2bn-$14.6bn, compared with $14.8bn last year.
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