Next-gen Amgen bone drug clears Ph2 hurdle

As Amgen execs braced themselves to give analysts an in-depth look at their business and R&D strategy today, the company set the stage with a pair of releases that heralded a significant mid-stage advance for a key experimental bone drug and appeased investors with an expected announcement of its first dividend.

Researchers for Amgen and its partner UCB say that AMG 785/CDP7851 cleared a Phase II trial, meeting its primary endpoint by demonstrating "significant increases in lumbar spine bone mineral density at month 12 for the AMG 785/CDP7851 active arms versus the placebo arm." The drug compared positively with the two active comparators, teriparatide and alendronate. And that leaves the developers on the threshold of an ambitious late-stage study.

While Amgen has been building up a solid market for its bone drug denosumab, AMG 785--which Xconomy's Luke Timmerman has described as the "son of Dmab"--represents a new approach to claiming a larger share of the multibillion-dollar market of osteoporosis treatments. While Dmab prevents bone erosion, the AMG 785 antibody is designed to block sclerostin, helping osteoblasts rebuild bone.

"We are very encouraged by the results of this study," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "Despite available osteoporosis therapies, there remains a significant need for additional treatment options that form new bone in women with postmenopausal osteoporosis. We look forward to working with UCB to advance the AMG 785/CDP7851 program into Phase III."

Amgen told investors it expects to earn between $16 and $18  billion by 2015, but the news failed to impress investors. The stock slipped two percent this morning. Amgen says that its annual dividend will amount to about 20 percent of adjusted net income.

- take a look at the Amgen release
- here's the story from Reuters