Amgen’s Prolia approved in Europe
pharmafile | June 1, 2010 | News story | Sales and Marketing | Amgen, Prolia
A blockbuster future is predicted for the osteoporosis treatment Prolia, with global sales predicted to reach $5 billion.
European regulators have approved Amgen’s first-in-class Prolia (denosumab) giving it the green light to treat post-menopausal women with osteoporosis.
The monoclonal antibody treatment uses a new mode of action and only needs to be given, via injection, twice a year.
“The European approval of Prolia is a significant medical advance for patients with bone loss conditions,” said Will Dere, senior vice president and international chief medical officer at Amgen. “In particular, we believe that Prolia will offer patients with post-menopausal osteoporosis at increased risk for fracture an important alternative to current treatments.”
Analysts have high hopes for the drug, which will be commercialised by Amgen and its marketing partner GlaxoSmithKline, and are predicting global sales that could reach $5 billion. This year industry analysts EvaluatePharma placed Prolia top of its 20 most valuable R&D projects for the second year running, with annual earnings forecast to be $5.03 billion by 2016.
The drug works by inhibiting osteoclast formation, function and survival, thereby reducing the risk of future fractures and increasing bone density. In July 2009, Amgen and GSK signed a collaboration agreement to jointly commercialise Prolia for post-menopausal osteoporosis in Europe, Australia, New Zealand and Mexico, once the product is approved in these countries.
In addition, GSK will register and commercialise Prolia for all indications in countries where Amgen does not currently have a commercial presence, including: China, Brazil, India and South Korea – but excluding Japan.
Amgen and Daiichi-Sankyo Company have a collaboration and license agreement for the development and commercialisation of Prolia in Japan. Prolia also has indications in oncology and bone loss due to certain cancers. Amgen will commercialise the drug for post-menopausal osteoporosis and oncology in the US and Canada and for all oncology indications in Europe and in other specified markets.
One of the biggest-selling treatments on the market at the moment is Roche/GlaxoSmithKline’s once-monthly oral Boniva that was approved in 2005.
Merck is currently developing its once-weekly oral treatment odanabatib for the same indication but phase II results have shown that the drug’s success is significantly reduced once treatment was stopped.
The previous blockbuster osteoporosis drug was Merck’s Fosamax, an oral bisphosphonate compound that lost its patent in 2009.
Fosamax came under heavy criticism after some patients claimed it caused them osteonecrosis of the jaw.
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