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Radius Health Has Submitted A Marketing Authorization Application For The Investigational Drug Abaloparatide-Sc For The Treatment Of Postmenopausal Osteoporosis In Europe

The following excerpt is from the company's SEC filing.

Todays submission represents the Companys 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


., November 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 abalop aratide 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 Companys 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 Companys 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 Companys presentation will be available on the Companys website approximately two hours following the completion of the event.


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 Healths 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.