-Highlights from Phase 3 ACTIVE and ACTIVExtend Trials-
-New Results from WHO FRAX® assessment of ACTIVE Trial demonstrate consistency of fracture risk reduction-
-WCO-IOF-ESCEO Malaga 2016 is the largest forum for clinical research and education in osteoporosis, osteoarthritis and musculoskeletal diseases in Europe-
WALTHAM, Mass., April 15, 2016 (GLOBE NEWSWIRE) -- Radius Health Inc. (Nasdaq:RDUS) a science-driven biopharmaceutical company committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases announced three oral presentations were made today at the 2016 World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases meeting in Malaga, Spain:
- Dr. Lorie Fitzpatrick, Chief Medical Officer of Radius Health presented "Effects of Abaloparatide on Vertebral, Non-Vertebral, Major Osteoporotic and Clinical Fracture Incidence in Postmenopausal Women with Osteoporosis: Results of the Phase 3 Active Trial"
- Dr. Serge Ferrari, Professor of Medicine, Geneva University presented "Eighteen Months of Treatment with Abaloparatide Followed by Six Months of Treatment with Alendronate in Postmenopausal Women with Osteoporosis- Results of the ACTIVExtend Trial"
- Dr. Eugene McCloskey, Professor in Adult Bone Diseases, University of Sheffield presented "Effect of Investigational Treatment Abaloparatide for Prevention of Major Osteoporotic Fracture or Any Fracture is Not Altered by Baseline Fracture Probability”
Radius was pleased to share the clinical results from the development program for abaloparatide-SC at this well attended international meeting.
“The data from ACTIVE and ACTIVExtend demonstrate the reduction of the risk of fracture at all skeletal sites and the potential for sequential therapy,” said Dr. Serge Ferrari, the presenting author. “These results provide a clinician an understanding of how to build bone with an anabolic agent and then switch to an antiresorptive agent while maintaining fracture risk reduction.”
“FRAX® is an internationally validated, freely available, fracture risk assessment tool that can easily identify individuals at the greatest risk of osteoporotic fracture who will benefit from appropriate therapies,” said Dr. Eugene McCloskey, the presenting author. “Today’s presentation showed that abaloparatide-SC significantly reduced the risk of major osteoporotic fracture and any clinical fracture across the full range of baseline FRAX risk for the postmenopausal women in the Phase 3 ACTIVE trial.”
Abaloparatide-SC as a treatment for postmenopausal women with osteoporosis is an investigational product and its safety and efficacy have not been established.
The FRAX® tool has been developed by the University of Sheffield in association with the WHO to evaluate fracture risk of patients. It is based on individual patient models that integrate the risks associated with clinical risk factors as well as bone mineral density (BMD) at the femoral neck.
The FRAX® models have been developed from studying population-based cohorts from Europe, North America, Asia and Australia. In their most sophisticated form, the FRAX® tool is computer-driven. Several simplified paper versions, based on the number of risk factors are also available, and can be downloaded for office use.
The FRAX® algorithms give the 10-year probability of fracture. The output is a 10-year probability of hip fracture and the 10-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture). Learn more at https://www.shef.ac.uk/FRAX/.
FRAX is a registered trademark of The Centre for Metabolic Bone Diseases at the University of Sheffield.
Radius is a science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases. Radius' lead product candidate, the investigational drug abaloparatide for subcutaneous injection, has completed Phase 3 development for potential use in the reduction of fracture risk in postmenopausal women with osteoporosis. Radius' Marketing Authorisation Application (MAA) for abaloparatide-SC for the treatment of postmenopausal women with osteoporosis is under regulatory review in Europe and a New Drug Application (NDA) was submitted in the U.S. at the end of the first quarter of 2016. The Radius clinical pipeline also includes an investigational abaloparatide transdermal patch for potential use in osteoporosis and the investigational drug RAD1901 for potential use in hormone-driven and/or hormone-resistant breast cancer, and vasomotor symptoms in postmenopausal women. Radius' preclinical pipeline includes RAD140, a non-steroidal, selective androgen receptor modulator (SARM) under investigation for potential use in multiple applications including cancer.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding expectations for abaloparatide-SC, including without limitation, expectations regarding the clinical significance of clinical trial data for abaloparatide-SC, including data from the FRAX tool assessment, the potential medical benefit of treatment with abaloparatide-SC for postmenopausal women with osteoporosis, the progress of abaloparatide-SC in the regulatory process with the FDA and the EMA, and the potential clinical uses for the abaloparatide transdermal patch, RAD1901 and RAD140.
These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the risk that the results of clinical trials of abaloparatide-SC will not meet regulatory requirements for approval or that regulatory authorities may require additional data or further studies; our dependence on the success of abaloparatide-SC, and our inability to ensure that abaloparatide-SC will obtain regulatory approval or be successfully commercialized; the risk that results of clinical trials of abaloparatide-SC and of our other product candidates may not support product claims, even if approved; failure to achieve market acceptance of abaloparatide-SC, if approved; the availability of coverage and reimbursement for abaloparatide-SC, if approved; the risk that a regulatory or government official will determine that third-parties with a financial interest in the outcome of the Phase 3 study of abaloparatide-SC affected the reliability of the data from the study; failure to establish an effective process for distribution of abaloparatide-SC; and the other important factors discussed under the caption "Risk Factors" in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on February 25, 2016, and in our other reports filed with the SEC, that could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
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