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Osteoporosis treatment post breast cancer may rescue Amgen

US biotech Amgen is developing denosumab to prevent fractures in breast cancer patients receiving hormonal therapy to make up for flagging sales of anaemia drug, Aranesp

US biotech Amgen is developing denosumab to prevent fractures in breast cancer patients receiving hormonal therapy to make up for flagging sales of anaemia drug, Aranesp.

Denosumab is a highly specific monoclonal antibody, which interrupts the development of specialised cells that break down bone. Because it is highly specific, the chance of systemic effects in other parts of the body is low, so patients do not need routine laboratory monitoring.

Aromatase inhibitors are currently used to prevent the recurrence of breast cancer in postmenopausal women, but they are associated with loss of bone density and an increased risk of fractures.

Dr Georgiana Ellis from the Seattle Cancer Care Alliance presented results of a phase III clinical trial using denosumab at the San Antonio Breast Cancer Symposium on 14 December.

To test the effectiveness of denosumab in preventing bone loss caused by aromatase inhibitors, the two-year clinical trial recruited 252 patients who had been treated for early stage breast cancer and for whom treatment with anastrozole, an aromatase inhibitor, was planned. Half of the patients were given denosumab, while the other half was not. All patients were instructed to take daily doses of calcium and vitamin D.

By the end of the first year, the bone density in the spines of the women receiving denosumab had increased by nearly five per cent, while the women who did not receive denosumab had bone density decreases of almost one per cent.

By the end of the second year, the difference was even greater: in the women receiving denosumab, bone density had increased by almost six per cent, while the bone density of the women who did not receive denosumab decreased by nearly two per cent. Similar effects on bone density were seen at the hip and the wrist.

Denosumab to Amgen's rescue?
The year 2007 has been a bad one for Amgen. Safety concerns about anaemia drugs led to an FDA warning and caused sales of Amgen's most profitable drug, Aranesp, to plummet.

Amgen is now looking to take advantage of the USD 7bn osteoporosis market with denosumab. According to optimistic analysts, denosumab could achieve sales topping USD 2bn a year if and when approved for both osteoporosis and cancer patients. That would go a long way in turning around the company's fortunes. Amgen hopes to file an NDA for the drug in 2009.

Friedman, Billings and Ramsey analysts are less positive. They say that annual denosumab sales could reach USD 875m by 2012, which would not enough to save the company. They said that Amgen's best option to ensure future growth is to acquire a younger, fast-growing biotech like Celgene.

16th December 2007

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