Analysts have dubbed denosumab the white knight that will rescue Amgen from its flagging core franchises. In 2009, the $5.2 billion erythropoietin-stimulating agent duo of Aranesp (darbepoetin alfa) and Epogen (epoetin alfa) lost a bit of ground, as did the $3.5 billion arthritis/psoriasis drug Enbrel (etanercept).
If denosumab turns into a $4 billion drug, as analysts hope, it will more than pick up the slack. But last fall, the FDA smacked Amgen with complete response letters in all of denosumab's first six target bone-loss indications. To make matters worse, the agency asked for new clinical trials in all indications except the treatment of postmenopausal osteoporosis -- for that one Amgen just had to provide post-marketing surveillance information, which the biotech said in its earnings release it has now done.
Assuming the FDA accepts Amgen's submission, the clock is now ticking toward an approval either two months or six months down the road. The postmenopausal osteoporosis indication is worth three times more than the other five bone loss indications combined, and Amgen's sales force is poised and ready for launch.
So what could be bigger than the denosumab osteoporosis approval and launch? Denosumab's potential in cancer -- an indication worth upwards of $3 billion, three times more than osteoporosis.
Data from a Phase III study aiming to reduce fracture risk in prostate cancer that has metastasized to the bone are expected this quarter, and data from a Phase III trial aiming to prevent bone metastases in prostate cancer patients are expected in the second half.
Credit Suisse analyst Michael Aberman called these data the biggest driver for Amgen's 2010 stock performance. Deutsche Bank analyst Mark Schoenebaum said the metastasis prevention data, in particular, are the "single biggest stock event for Amgen this year." And Leerink Swann analyst Joshua Schimmer went as far as to say the metastases prevention data are "one of the best risk-reward binary events in large cap biotech for 2010."
Fasten your seatbelts, kiddos, this could be one helluva ride.
White knight photo by Flickr user James Cridland, CC.