• Today’s submission represents the Company’s first application to register a new medicine
• If approved, abaloparatide-SC would be the first new bone anabolic in Europe since 2003
• Company provides update on timing for NDA submission
WALTHAM, Mass., Nov. 17, 2015 (GLOBE NEWSWIRE) -- Radius Health (Nasdaq:RDUS), today announced that it has submitted a Marketing Authorization Application (MAA) for an investigational, once-daily subcutaneous injection of abaloparatide, a novel synthetic peptide. In addition to other data, the MAA is supported by clinical studies exploring the use of abaloparatide for the treatment of women with postmenopausal osteoporosis, including the pivotal 18-month ACTIVE study which enrolled 2463 women. The announcement is being made during the Company’s Investor Day meeting being held today in New York City.
“Today marks a major milestone for Radius Health with the submission of our MAA in Europe for the investigational drug abaloparatide-SC for the potential treatment of postmenopausal osteoporosis.” said Robert E. Ward, President and CEO of Radius Health. “This is the first step towards achieving our goal to make abaloparatide available to patients around the world who are suffering from the burden of osteoporosis.”
At Investor Day, Radius Management discussed the Company’s latest progress and plans for the further development and, subject to receipt of approval following positive regulatory review, commercialization of abaloparatide, RAD1901 and RAD140. A replay of the webcast of the Company’s presentation will be available on the Company’s website approximately two hours following the completion of the event.
Abaloparatide
Following the completion and reporting of the positive top line results for the Phase 3 ACTIVE trial and the first six months of ACTIVExtend, Radius has now submitted the MAA for the investigational drug abaloparatide-SC in the EU. The Company is now turning its focus to the completion of the work streams necessary for the submission of the New Drug Application (NDA) to the FDA for the investigational drug abaloparatide-SC. For the MAA, the Company has submitted 6-month stability data for abaloparatide in accordance with European requirements. As additional data become available, they will be submitted in support of our targeted 3-year shelf life for the commercial product following receipt of regulatory approval.
In the US, the FDA requires that 12-month stability data be submitted at the time of the NDA. The 12-month time point for the abaloparatide stability samples will be reached in December 2015 and Radius expects to initiate data analysis in January 2016. To accommodate this analytic plan, the Company announced a change in the NDA submission timing to the end of the first quarter of 2016. Similar to the European submission, as additional stability data become available they will be submitted in support of Radius’ targeted 3-year shelf life for the commercial product following receipt of regulatory approval. The Company believes that the stability data supporting both the MAA submission and the planned NDA submission will be sufficient to meet the regulatory standards for approval.
Radius plans to commence a clinical evaluation for an optimized abaloparatide transdermal patch by the end of 2015. Radius confirmed that partnership discussions regarding abaloparatide commercialization are ongoing and that the Company expects to announce a partnership by the time of first commercial launch. Radius Health’s ideal partner for abaloparatide would have experience in the development and commercialization of therapeutics to treat osteoporosis and related bone metabolic disorders.
The Company reviewed the high unmet medical need associated with osteoporosis noting that, according to the International Osteoporosis Foundation, there is an osteoporosis-related fracture every three seconds worldwide. A Mayo Clinic paper published in 2015 estimates that the number of days of hospitalization related to osteoporotic fractures is significantly greater than the days of hospitalization for myocardial infarction, stroke, or breast cancer.
RAD1901
The investigational drug RAD1901, a selective estrogen receptor degrader, is currently being studied for potential use in metastatic breast cancer. Despite the introduction of new treatment options for metastatic breast cancer patients over the past decade, there remains a significant unmet medical need and a high rate of treatment resistance across first and second line therapies. Radius believes that a once-daily oral therapy such as the investigational drug RAD1901 may hold the potential to provide an important option as a single agent for overcoming endocrine resistance and to offer a profile well suited for use in combination therapy as well. Upcoming milestones for RAD1901 are:
• Radius plans to provide an update on the ongoing Phase 1 dose escalation study in metastatic breast cancer patients at the San Antonio Breast Cancer Symposium in December 2015.
• Radius expects to initiate an additional Phase I clinical trial in metastatic breast cancer patients in the European Union in December 2015.
• Radius intends to commence a Phase 2b trial for low-dose RAD1901 for vasomotor symptoms in December 2015.
RAD140
The investigational drug RAD140, a nonsteroidal selective androgen receptor modulator, or SARM, is currently in preclinical development as a potential treatment for breast cancer. The androgen receptor (AR) is highly expressed in many estrogen receptor (ER)-positive breast cancers.
• Radius expects to commence a Phase 1 trial for the investigational drug RAD140 after making an Investigational New Drug (IND) submission in 2016.
About Radius Health
Radius is a science-driven biopharmaceutical company developing new therapeutics for patients with advanced osteoporosis as well as other serious endocrine-mediated diseases including hormone responsive cancers. Radius’ lead development candidate is the investigational drug abaloparatide for subcutaneous injection, currently in Phase 3 development for potential use in the reduction of fracture risk in postmenopausal women with severe osteoporosis. The Radius clinical portfolio also includes an investigational abaloparatide transdermal patch for potential use in osteoporosis and the investigational drug RAD1901 for potential use in hormone driven, or hormone resistant, metastatic breast cancer, and vasomotor symptoms. www.radiuspharm.com
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