- Management to host conference call today at 7:30 am ET
WALTHAM, Mass., May 6, 2015 (GLOBE NEWSWIRE) -- Radius Health, Inc. (“Radius”) (Nasdaq:RDUS), a science-driven biopharmaceutical company focused on developing new therapeutics for patients with osteoporosis as well as other serious endocrine-mediated diseases, including hormone responsive breast cancer, reported its financial results for the first quarter ended March 31, 2015, and provided recent corporate highlights. As of March 31, 2015, Radius had cash, cash equivalents and marketable securities of $243.1 million, including $158.4 million in proceeds from a public offering on January 28, 2015, net of underwriting discounts and offering costs.
“Radius has already achieved a number of significant milestones in 2015, including a successful follow-on offering in January,” said Robert Ward, President and Chief Executive Officer of Radius Health. “We are taking the necessary steps to achieve our critical priorities in 2015: preparing for our NDA and MAA submissions for the investigational drug abaloparatide-SC, seeking a global collaborator and planning for the potential commercial launch of abaloparatide-SC following regulatory approval. In oncology, we are pleased to be continuing to enroll and dose patients in our Phase 1 study for the investigational drug RAD1901 to evaluate its potential in the treatment of metastatic breast cancer.”
Pipeline Update
Abaloparatide-SC
On April 28, 2015, additional positive data from the Phase 3 ACTIVE study of our investigational drug abaloparatide-SC, “Treatment with Abaloparatide Significantly Reduces Wrist Fractures Compared to Teriparatide”, was presented in the HOT TOPICS Session at the ECTS-IBMS 2015 Congress. This presentation focused on data from a post-hoc analysis (not prespecified in the study protocol or the original or amended statistical analysis plan for the ACTIVE trial) relating to the effects seen for abaloparatide on bone mineral density and fracture risk at the wrist. The post-hoc analysis showed that abaloparatide, as compared to teriparatide, showed a significant 72% reduction in wrist fractures. Any potential clinical significance of these data will be evaluated during the anticipated regulatory review of these and all other data from the ACTIVE trial.
In the ACTIVE Phase 3 clinical trial, abaloparatide-SC demonstrated the largest reduction ever reported in vertebral fracture risk versus placebo of 86%. Importantly, the ACTIVE trial demonstrated that abaloparatide-SC resulted in more bone growth, at more skeletal sites, and in more patients than an open-label arm in which the current standard of care was administered. These data indicate that the unique structure and mechanism of abaloparatide translate to a longer anabolic window and reduced calcium resorption versus native PTH, which, subject to regulatory review, may have clinical significance at some of the most difficult to treat non-vertebral sites, such as the hip, wrist and femoral neck.
Radius is on track to report the results of the first six months of the ACTIVExtend trial at the end of the second quarter of 2015. Patients from the abaloparatide-SC and placebo groups from the ACTIVE clinical trial were eligible to continue in ACTIVExtend, in which they are receiving an approved alendronate therapy for osteoporosis management. The results from this ACTIVExtend six month period will be combined with the 18 month Phase 3 ACTIVE results to provide the complete 24-month data set. This will form the basis of Radius’ planned submission of a new drug application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) and of a marketing authorization application (“MAA”) to the European Medicines Agency (“EMA”), in the second half of 2015. We currently anticipate a standard review at the FDA and EMA with, pending a positive regulatory outcome, first commercial sales of abaloparatide in 2016.
During the quarter, Radius continued the nonhuman primate pharmacokinetic studies of the investigational drug abaloparatide‑TD, a short wear time transdermal patch form of abaloparatide. In December 2014, we reported that a prototype achieved a desirable pharmacokinetic profile, with comparable AUC, Cmax, Tmax and T1/2 relative to abaloparatide-SC. Radius expects to initiate the clinical evaluation of the optimized abaloparatide-TD patch in the second half of 2015, with the goal of achieving comparability to abaloparatide-SC.
RAD1901
Radius is continuing to enroll and dose patients in the United States in the Phase 1 clinical trial of the investigational drug RAD1901 for potential use in the treatment of metastatic breast cancer. The Phase 1 study is a multicenter, open-label, two-part, dose-escalation study of RAD1901 in postmenopausal women with advanced estrogen receptor positive and HER2-negative breast cancer that is designed to determine the recommended dose for a Phase 2 study and includes a preliminary evaluation of the potential anti-tumor effect of RAD1901. Radius expects to report an update on the Phase 1 study at the American Society of Clinical Oncology Annual Meeting that is scheduled to take place May 29-June 2, 2015, and to report further progress on this study in the second half of 2015. Radius plans to initiate Phase 1 clinical development in the European Union for RAD1901 in metastatic breast cancer patients in 2015.
During the quarter, Radius secured worldwide rights for RAD1901 by amending its license agreement with Eisai Co. Ltd. This is an important step as Radius looks to expand the potential therapeutic profile for RAD1901.
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