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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.
	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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19	19	[[image:https://www.sec.gov/Archives/edgar/data/1428522/000162828018002666/pipelinecharta08.jpg]]
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21		-**Abaloparatide**
	21	+== Abaloparatide ==
22	22
23	23	In April 2017, the FDA approved TYMLOS 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. Radius Health is developing two formulations of abaloparatide: abaloparatide-SC, an injectable subcutaneous formulation of abaloparatide, and abaloparatide-patch, a short-wear-time patch formulation of abaloparatide.
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39	39	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.
40	40
41		-**Abaloparatide-patch**
	41	+== Abaloparatide-patch ==
42	42
43	43	Radius Health is also developing abaloparatide-patch, based on 3M’s patented Microstructured Transdermal System technology, for potential use as a short wear-time transdermal patch. The company hold worldwide commercialization rights to the abaloparatide-patch technology and Radius Health is developing abaloparatide-patch toward future global regulatory submissions to build upon the potential success of TYMLOS. The company's development strategy for abaloparatide patch is to bridge to the established efficacy and safety of its approved abaloparatide-SC formulation.
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47	47	In January 2018, the company met with the FDA to align on a regulatory and development path for registration of abaloparatide-patch. The company 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. On February 27, 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.
48	48
49		-**Elacestrant (RAD1901)**
	49	+== Elacestrant (RAD1901) ==
50	50
51	51	Elacestrant is a SERD that Radius Health is evaluating for potential use as an oral treatment for hormone-receptor positive breast cancer. The company hold worldwide commercialization rights to elacestrant. Elacestrant is currently being investigated in women with advanced estrogen receptor positive (“ER-positive”) and human epidermal growth factor receptor 2-negative (“HER2-negative”) breast cancer, the most common subtype of the disease. Studies completed to date indicate that the compound has the potential for use as a single agent, or in combination with other therapies for the treatment of breast cancer. To date, no dose limiting toxicities have been reported in the elacestrant program. The company believe that, subject to successful development, regulatory review and approval, elacestrant could have the potential to offer the following advantages compared to current standard of care treatments for ER-positive and HER2-negative breast cancer:
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73	73	In December 2017, the company reported updated data from the Phase 1 FES-PET study that elacestrant demonstrated robust reduction in tumor ER availability in patients with advanced ER+ breast cancer who progressed on prior endocrine therapy. Seven out of eight patients dosed at the 400-mg cohort, and four out of seven patients dosed at the 200-mg cohort, had a tumor FES-PET signal intensity reduction equal to, or greater than, 75% at day 14 compared to baseline. The reduction in FES uptake supports flexibility for both 200-mg and 400-mg elacestrant dose selection for further clinical development in combination studies with various targeted agents and was similar in patients harboring mutant or wild-type ESR1. The most commonly reported adverse events reported were grade 1 and 2 nausea and dyspepsia.
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75		-**Potential for use in Combination Therapy**
	75	+== Potential for use in Combination Therapy ==
76	76
77	77	In July 2015, the company announced that early but promising preclinical data showed that its investigational drug elacestrant, in combination with Pfizer’s palbociclib, a cyclin-dependent kinase ("CDK 4/6 inhibitor") or Novartis’ everolimus, an mTOR inhibitor, was effective in shrinking tumors. In preclinical patient-derived xenograft breast cancer models with either wild type or mutant ESR1, treatment with elacestrant resulted in marked tumor growth inhibition, and the combination of elacestrant with either agent, palbociclib or everolimus, showed anti-tumor activity that was significantly greater than either agent alone. The company believe that this preclinical data suggests that elacestrant has the potential to overcome endocrine resistance, is well-tolerated, and has a profile that is well suited for use in combination therapy.
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337	337	PPL may terminate the agreement for any reason upon 30-months’ notice. The company may terminate the Manufacturing Agreement for any reason upon 24-months’ notice, if the company fail to obtain regulatory marketing approval for abaloparatide upon 12-months’ notice to PPL, or if abaloparatide is withdrawn from the market upon 12-months’ notice to PPL. Either party may terminate the agreement for the other's uncured breach of the agreement due to a party’s bankruptcy, insolvency, or dissolution, or due to certain force majeure events.
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339	339	= References =
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	341	+{{putFootnotes/}}