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5	5	= Overview =
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7		-Radius Health is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine therapeutics in the areas of osteoporosis and oncology. In April 2017, its first commercial product, TYMLOSTM (abaloparatide) injection, was approved by the U.S. Food and Drug Administration ("FDA") for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In May 2017, the company commenced U.S. commercial sales of TYMLOS and, as of February 2018, TYMLOS was available and covered for approximately 259 million U.S. insured lives, representing approximately 86% of U.S. insured lives. In May 2017, the company also announced positive top-line results from its completed 24-month ACTIVExtend clinical trial for TYMLOS, which met all of its primary and secondary endpoints. The company submitted a labeling supplement to the FDA in connection with the results from its ACTIVExtend trial in December 2017. In July 2017, the company entered into a license and development agreement with Teijin Limited (“Teijin”) for abaloparatide for subcutaneous injection (“abaloparatide-SC”) in Japan. Under this agreement, Radius Health is entitled to receive milestone payments upon the achievement of certain regulatory and sales milestones and a fixed low double-digit royalty based on net sales of abaloparatide-SC in Japan during the royalty term, and Radius Health has an option to negotiate for a co-promotion agreement with Teijin for abaloparatide-SC in Japan. The company's European Marketing Authorisation Application (“MAA”) for abaloparatide-SC is under review by the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) and the company expect an opinion from the CHMP regarding the MAA during the first half of 2018. In the first quarter of 2018, the company expect to initiate a clinical trial in men with osteoporosis which, if successful, will form the basis of a supplemental new drug application ("NDA") seeking to expand the use of TYMLOS to treat men with osteoporosis at high risk for fracture. In the first half of 2018, the company plan to initiate a bone histomorphometry study, which would enroll approximately 25 postmenopausal women with osteoporosis to evaluate the early effects of TYMLOS on tissue-based bone remodeling and structural indices.{{footnote}}https://fintel.io/doc/sec-rdus-radius-health-10k-2018-march-01-17945{{/footnote}}
	7	+Radius Health (RDUS) is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine therapeutics in the areas of osteoporosis and oncology. In April 2017, its first commercial product, TYMLOSTM (abaloparatide) injection, was approved by the U.S. Food and Drug Administration ("FDA") for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In May 2017, the company commenced U.S. commercial sales of TYMLOS and, as of February 2018, TYMLOS was available and covered for approximately 259 million U.S. insured lives, representing approximately 86% of U.S. insured lives. In May 2017, the company also announced positive top-line results from its completed 24-month ACTIVExtend clinical trial for TYMLOS, which met all of its primary and secondary endpoints. The company submitted a labeling supplement to the FDA in connection with the results from its ACTIVExtend trial in December 2017. In July 2017, the company entered into a license and development agreement with Teijin Limited (“Teijin”) for abaloparatide for subcutaneous injection (“abaloparatide-SC”) in Japan. Under this agreement, Radius Health is entitled to receive milestone payments upon the achievement of certain regulatory and sales milestones and a fixed low double-digit royalty based on net sales of abaloparatide-SC in Japan during the royalty term, and Radius Health has an option to negotiate for a co-promotion agreement with Teijin for abaloparatide-SC in Japan. The company's European Marketing Authorisation Application (“MAA”) for abaloparatide-SC is under review by the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) and the company expect an opinion from the CHMP regarding the MAA during the first half of 2018. In the first quarter of 2018, the company expect to initiate a clinical trial in men with osteoporosis which, if successful, will form the basis of a supplemental new drug application ("NDA") seeking to expand the use of TYMLOS to treat men with osteoporosis at high risk for fracture. In the first half of 2018, the company plan to initiate a bone histomorphometry study, which would enroll approximately 25 postmenopausal women with osteoporosis to evaluate the early effects of TYMLOS on tissue-based bone remodeling and structural indices.{{footnote}}https://fintel.io/doc/sec-rdus-radius-health-10k-2018-march-01-17945{{/footnote}}
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9	9	Radius Health is developing an abaloparatide transdermal patch, or abaloparatide-patch, for potential use in the treatment of postmenopausal women with osteoporosis. In January 2018, the company met with the FDA and gained alignment with the agency on a single, pivotal BMD non-inferiority bridging study to support an NDA submission. The FDA agreed that, depending on the study results, a randomized, open label, active-controlled, non-inferiority Phase 3 study of up to 500 patients with postmenopausal osteoporosis at high risk of fracture would be sufficient to gain approval for abaloparatide-patch. The FDA confirmed that the primary endpoint will be change in lumbar spine BMD at 12 months and that the non-inferiority margin must preserve 75% of the active control (abaloparatide-SC) based on the lower bound of the 95% confidence interval. The company expect to initiate this pivotal study in mid-2019 and to complete it in 2020. In February 2018, the company entered into a scale-up and commercial supply agreement with 3M Company pursuant to which 3M has agreed to exclusively manufacture Phase 3 and global commercial supplies of abaloparatide-patch.
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