Another boost for Amgen as US FDA approves injectable osteoporosis drug Prolia, with peak sales expectations of as much as $6 billion

There was good news for US biotechnology major Amgen yesterday, when the Food and Drug Administration approved the firm's Prolia (denosumab), an injectable treatment for postmenopausal women with osteoporosis at high risk for fractures, some two months earlier than had been expected and just days after the drug was cleared for marketing in Europe (The Pharma Letter May 28).

Prolia is viewed as Amgen's biggest future growth driver, and the news saw its shares, which had fallen 2% in regular trading yesterday to jump 4.4% to $53 in post-market trading. Analysts' sales forecasts for the new osteoporosis treatment have ranged between $3.3 billion to $5 billion a year at peak, and will vie in a total market sector estimated at $8.4 billion in 2008 by IMS Health. In addition, if the drug garners approval for additional indications, Cowen & Co analyst Craig Gordon suggests that it could generate revenues of up to $6 billion. Amgen is also seeking FDA approval for cancer-related bone loss.

Will launch at $825 per shot in competitive market

Amgen says it will start selling Prolia - which is administered as a subcutaneous injection every six months - to doctors in the USA within two weeks at a wholesale price of $825 for a single 60mg shot.