Amgen Passes Key Trial With “Son of Dmab” For Osteoporosis

Xconomy National — 

The financial crowd who follows Amgen may be talking all about dividends or techniques to boost the stock through share buybacks, but the medical and scientific world will be chirping today about an interesting new finding the company has made for treating osteoporosis.

Amgen (NASDAQ: AMGN), the Thousand Oaks, CA, biotech giant with R&D operations in Seattle, South San Francisco, and Cambridge, MA, said today an experimental drug met its goal of improving bone mineral density in a study of 400 postmenopausal women. Details are being saved for a medical meeting, but Amgen said its drug, AMG785, beat a placebo and two comparison drugs, after 12 months of follow-up. The rate of side effects was “generally balanced” between those patients on the new drug and those in the control groups, Amgen said.

The new treatment, being developed in collaboration with Belgium-based UCB, will now advance into the third and final stage of testing, Amgen said.

“Despite available osteoporosis therapies, there remains a significant need for additional treatment options that form new bone in women with postmenopausal osteoporosis,” said Roger Perlmutter, Amgen’s executive vice president of R&D, in a statement.

Amgen made the AMG785 announcement as its management team is meeting with analysts in New York to talk about the company’s long-term financial outlook. After years of prodding from shareholders, Amgen confirmed in a separate statement that it will introduce its first dividend for shareholders, starting next quarter.

While dividends are usually for old fuddy-duddy stocks for widows and orphans, Amgen has sought to hold onto some of the perception that it still has high growth potential. And Amgen has generated a lot of attention in the past year for its new bone treatment denosumab, which is now FDA-approved for treating osteoporosis and cancer-related bone fractures. The company projects that drug in its two marketed forms will generate $3 to $4 billion in sales by 2015.

But while denosumab works to stop the excessive breakdown of bone, the new drug, AMG785 is designed to work differently, so that the body can build up stronger, more dense bone material, as Amgen chief medical officer Sean Harper explained in an interview earlier this year. If the new drug passes the final stage of clinical trials, Amgen could be in position to capture a bigger share of the $9 billion-plus osteoporosis market as some older drugs turn generic. An estimated one out of five women over 50 in the U.S. have osteoporosis.