Amgen's (NASDAQ: AMGN) great new hope--the bone drug Prolia--won priority review at the FDA for a new, potentially lucrative cancer indication. The use: cancer that has spread to bone. The upshot: an approval could boost sales of the new drug to roughly $3 billion by 2015, analysts say.
Prolia won the FDA nod as an osteoporosis treatment June 1. But the drug isn't expected to vault to quick success in that market. After all, it's crowded with alternatives such as Merck's Fosamax, which recently went generic, and Roche's Boniva. Recently, Decision Resources predicted that the drug could build to just $500 million in osteoporosis sales by 2019.
Amgen is really counting on pushing Prolia as a treatment for cancer patients. That's why it submitted data for this second indication even before it won FDA's initial approval. The sooner it can get a cancer approval, the sooner it can start touting Prolia to a very receptive market. With this priority-review designation, that date could be as soon as November 18.