WALTHAM, Mass., July 20, 2016 (GLOBE NEWSWIRE) -- Radius Health, Inc. (Nasdaq:RDUS), a science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, announced today that it will present new data from multiple studies of abaloparatide in women with postmenopausal osteoporosis at the American Society for Bone and Mineral Research (ASBMR) 2016 Annual Meeting, September 16-19, 2016, at the Georgia World Congress Center in Atlanta, Georgia.
The company will be presenting results of a Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetics of the optimized abaloparatide transdermal (ABL-TD) patch formulations as well as additional analyses from the abaloparatide-SC ACTIVE Phase 3 trial. Abstracts summarizing the abaloparatide data will be published on the ASBMR website in mid-August and will be available to conference registrants and ASBMR members shortly at http://www.asbmr.org/ASBMR-abstracts.
Abstracts related to Radius Health include:
Oral Late-Breaking Abstract Title: Clinical Development of an Optimized Abaloparatide Transdermal Patch
Abstract Title: Abaloparatide-SC has Minimal Effects in Subjects with Mild or Moderate Renal Impairment: Results from the ACTIVE Trial
Abstract Title: Abaloparatide-SC is an Effective Treatment Option for Postmenopausal Osteoporosis: Review of the Number Needed to Treat Compared with Teriparatide
Abstract Title: Effect of Investigational Treatment Abaloparatide-SC for the Prevention of Major Osteoporotic Fracture is Independent of Baseline Fracture Probability
Abaloparatide-SC Commercial Supply Agreements
Radius Health entered into agreements with Lonza Sales Ltd., Vetter Pharma International GmbH and Ypsomed AG for commercial supply of abaloparatide-SC, the Company’s lead investigational drug product. Lonza will manufacture the commercial supply of the active pharmaceutical ingredient (“API”) for abaloparatide. Ypsomed will supply a disposable pen injection device customized for injection of abaloparatide to be used in commercial distribution of abaloparatide. Vetter will formulate the drug product containing the API of abaloparatide to be delivered via subcutaneous injection, fill cartridges with the drug product and assemble the pen delivery device and package the pen for commercial distribution.
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) has been accepted for filing by the FDA. 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.
Abaloparatide is an investigational therapy for the potential treatment of postmenopausal women with osteoporosis. Abaloparatide is a novel synthetic peptide that engages the parathyroid hormone receptor (PTH1 receptor) and was selected for clinical development based on its favorable bone building activity.
Abaloparatide has completed Phase 3 development for potential use as a daily self-administered subcutaneous (SC) injection (abaloparatide-SC). Radius’ NDA for abaloparatide-SC was accepted for filing by the US Food and Drug Administration in May 2016, for the treatment of postmenopausal women with osteoporosis. In December 2015, Radius' MAA for abaloparatide-SC for the treatment of postmenopausal women with osteoporosis was validated by the European Medicines Agency for commencement of Centralised assessment by the Committee for Medicinal Products for Human Use (CHMP). The MAA is currently undergoing regulatory review by the CHMP.
Radius also is developing abaloparatide-transdermal (abaloparatide-TD) based on 3M's patented Microstructured Transdermal System technology for potential use as a short wear-time transdermal patch.
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, 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, the availability of commercial supply of abaloparatide, 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.
Source:Radius Health Inc.