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An ACTIVE accomplishment
WALTHAM, Mass.—Biopharmaceutical company Radius Health Inc. is seeking to bring a new treatment option for osteoporosis to market, and looks to be well on its way. The company shared news the other month that positive results from its Phase 3 ACTIVE (Abaloparatide Comparator Trial In Vertebral Endpoints) trial had been published in the Journal of Bone and Mineral Research (JBMR) in the article “Effects of Abaloparatide-SC on Fracture and Bone Mineral Density in Subgroups of Postmenopausal Women with Osteoporosis and Varying Baseline Risk Factors.”
“We are pleased to have these findings published in JBMR, as well as the opportunity to present additional scientific information about abaloparatide-SC as part of the American Society of Bone and Mineral Research 2016 Annual Meeting,” Dr. Lorraine A. Fitzpatrick, chief medical officer of Radius, reported in a press release. “Approximately two million osteoporotic fractures occur annually in the U.S., which create physical and psychological burdens for those affected by diminishing their independence and quality of life. Radius Health is committed to pursuing new therapeutic options which have the potential to improve outcomes for these patients.”
This compound is an investigational therapy for the potential treatment of postmenopausal women with osteoporosis. The peptide interacts with the parathyroid hormone receptor (PTH1 receptor) and has shown favorable bone-building activity. The ACTIVE trial was a randomized, double-blind, placebo-controlled, comparative, multicenter, 18-month international study. It consisted of 2,463 postmenopausal women with osteoporosis and sought to assess the efficacy and safety of abaloparatide-SC 80 mcg to reduce the risk of vertebral and nonvertebral fractures versus placebo.
Abaloparatide was found to reduce new morphometric vertebral fractures by 86 percent compared to placebo, and nonvertebral fractures by 43 percent in postmenopausal women with osteoporosis. In addition, the peptide increased bone mineral density by 3.4 percent at the hip, 2.9 percent at the femoral neck and 9.2 percent at the lumbar spine after 18 months.
The compound has completed Phase 3 development for potential use as a daily, self-administered injection (abaloparatide-SC), and at the end of the first quarter this year, Radius submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration. The application has been accepted for filing with a PDUFA date of March 30, 2017.
“Results from the Phase 3 ACTIVE trial show that abaloparatide-SC may provide substantial benefit for a broad range of postmenopausal women with osteoporosis irrespective of their baseline risk factors, including age and prior fracture history,” remarked Dr. Felicia Cosman, osteoporosis specialist and medical director of the Clinical Research Center at Helen Hayes Hospital, senior clinical director of the National Osteoporosis Foundation, professor of medicine at Columbia University, consultant to Radius and lead author of the paper. “These data are important for the large number of postmenopausal women who may be at risk of a fracture and show that anabolic therapy could provide more consistent, potent and early benefits and may be the most efficient way for these patients to achieve ultimate bone mineral density goals.”
Radius is also making the news as rumors pick up that it may be close to closing a deal to be acquired by Shire. In August, Seeking Alpha’s Ramiz Bozai noted that British newspapers the Financial Times and Telegraph had been circulating talk that companies such as Shire—and possibly Pfizer and Amgen—were interested in Radius, with the Telegraph sharing a rumor that Radius had turned down a $70-per-share bid from Shire (an offer that would be worth about $3 billion). Douglas W. House of Seeking Alpha shared on Oct. 11 that “The Fly reports that Shire plc is closing in on a “multi-billion dollar” take out of biopharmaceutical firm Radius Health.”
No comments have been made by either company addressing the rumors, but with these positive Phase 3 results and abaloparatide-SC’s pending NDA, Radius could be an attractive target. Moreover, there’s no lack of potential in the osteoporosis market; RnR Market Research published a report in October 2015 forecasting that the global osteoporosis market would reach more than $40 billion by 2019.