March 2, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Thousand Oaks, Calif.-based Amgen has changed plans to develop two properties in Thousand Oaks.
The company originally filed plans with the Thousand Oaks Planning Commission to develop two properties on 2150 W. Hillcrest Drive and 518 Rancho Conejo Boulevard for research and development purposes. However, they may still be used as office space or other commercial uses.
In 1994, the Amgen Center Specific Plan was approved for 100 acres that are the Amgen campus. Amgen planned to build two research and development buildings on those locations in 2011, but the project was changed. Now the company indicates it no longer needs the two parcels as part of its long-term plans.
There has been speculation that Amgen is priming for a major merger or acquisition. Inside sources at the company have told The Financial Times that it was considering acquisition targets in the $10 billion range.
Potential targets floated have been Seattle Genetics, Inc. , Alnylam Pharmaceuticals , Dr. Reddy’s Laboratories Ltd. , or Aspen Pharmacare HLD (APNHF).
On Feb. 22, Amgen and Brussels-based UCB announced topline results from their Phase III placebo-controlled Fracture study in postmenopausal women with osteoporosis (FRAME). The companies indicated that the patients treated with romosozumab met the trial’s endpoints by reducing the incidence of new vertebral fracture. It also met the secondary endpoint of reducing the incidence of clinical fractures. But, another secondary endpoint, cutting the incidence of non-vertebral fractures, was not.
“These data are encouraging and in meeting the co-primary endpoints of this study, romosozumab has shown to be effective in reducing the incidence of new vertebral fractures at months 12 and 24 and for clinical fractures as early as 12 months,” said Iris Loew-Friedrich, UCB’s chief medical officer and executive vice president, in a statement. “Deeper understanding of the results will help us to sharpen the profile of romosozumab in postmenopausal women with osteoporosis.”
Writing for The Motley Fool, Sean Williams wonders if this is going to be a major problem for the drug. He notes that the drug will compete with Eli Lilly (LLY)’s Forteo, and a drug being developed by Radius Health called abaloparatide. He writes that Forteo and abaloparatide, if approved, are once-daily injectable therapies. Amgen’s and UCB’s romosozumab, however, is a once-a-month injectable.
“If romosozumab demonstrated superiority over the placebo in both primary and secondary endpoints,” writes Williams, “it would likely be the clear leader in treating osteoporosis among postmenopausal women. But romosozumab’s failure to meet statistical significance in non-vertebral fractures now casts some degree of doubt over its future.”
Forteo’s patent expires in December 2018, which does open up the market a bit. However, Radius’ abaloparatide, seems to have an edge, with vertebral fractures being reduced by 86 percent in its ACTIVE study. And more to the point given Amgen’s recent results, Radius’s drug reduced non-vertebral fractures by about 43 percent.
“Amgen announced that romosozumab did not reduce the incidence of non-vertebral fractures versus control at months 12 and 24, a major win for Radius’ abaloparatide, in our view,” wrote Canaccord Genuity analyst John Newman in a report to investors. “We do not believe physicians will consider romosozumab a serious treatment options for osteoporosis vs. abaloparatide, given abaloparatide’s 43 percent non-vertebral reduction at 18 months [in the ACTIVE trial.]”
Williams does point out, however, that Amgen has the edge in terms of convenience, although it will likely lose some market share to Radius. He also notes that pricing will likely be a big factor, as well as the fact that Amgen and UCB have enough money to fund a major marketing initiative aimed at physicians. “Radius Health,” Williams writes, “which is still entirely in the clinical stages of its development, has no positive cash flow to speak of.”
Of course, Amgen isn’t relying on this new drug. It’s launched five new drugs since December 2014, and expanded its label for another approved drug. Meanwhile, analysts will be watching for new data in the second half of this year about the company’s cholesterol drug Repatha. Sales to date have been slower than expected, but if the drug showed a significant reduction in risk of death, it might take off.
