the correct functioning of the sclerostin protein and offer the desired bone cell-building effect in early stage studies. That drug, code-named AMG-785, is now one of the molecules that Amgen and its partner, Belgium-based UCB, are most excited about based on early studies that showed “a very robust response with a single injection,” Miletich says. The drug still has a lot to prove—it’s now in one Phase II trial and entering another—but it has forced its way to the top of Miletich’s priority list based on all indications from the early-stage studies.
There’s also a business case to be made for such a drug, and Miletich was no stranger to that. Nothing currently on the market for osteoporosis can build new bone. This product also dovetails nicely with the most visible drug in Amgen’s pipeline, denosumab. That product candidate, currently awaiting FDA approval, has been shown to lower fracture risk of patients through a different mechanism, stopping osteoclast cells from breaking down too much bone. That drug could generate $2.2 billion in annual sales by 2012, according to a Rodman & Renshaw analysis. Any new product that does the opposite—building up bone—could be given to patients with early-stage osteoporosis. Those patients could be brought back to a healthy state, and then put on denosumab therapy for “maintenance” to keep them healthy.
“This could give physicians and patients both sides of the lever,” Miletich says.
Whether that turns out to be true won’t be known until the late-stage clinical trials either prove or disprove what Miletich’s troops have done so far in their methodical quest to understand what the drug is doing at early stages. Even with a $3 billion research budget that can buy every state of the art tool, and recruit world-class scientists, Miletich made it clear this is still a very humbling industry.
“I don’t like to overhype things,” Miletich says. “All of us in the field do a disservice when we celebrate success in a way that comes out sounding like we’ve answered everything. That’s not true. Human biology is enormously complex.”
