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ACTIVExtend trial demonstrated sustained statistically significant fracture risk reduction through the 3.5 years of sequential therapy: TYMLOS followed by an antiresorptive Safety similar among all treatment groups with no cases of ONJ or AFF across the entire TYMLOS development program Planned sNDA submission of final ACTIVExtend study and presentation at future scientific conferences Company to Host Top Line Results and Launch Update Webcast Today (Wednesday, May 24, 2017) at 4:30 p.m. ET WALTHAM, Mass., May 24, 2017 (GLOBE NEWSWIRE) -- Radius Health, Inc. (Nasdaq:RDUS) a science-driven fully integrated biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, today announced positive top-line results from the completed 24 month ACTIVExtend trial, which met all of its primary and secondary endpoints. In ACTIVExtend, patients who had completed 18 months of TYMLOS (abaloparatide) injections or placebo in the ACTIVE Phase 3 trial were transitioned to receive 24 additional months of open-label alendronate. “There is a substantial unmet medical need among postmenopausal women with osteoporosis at high risk of a fracture and we believe that these women deserve access to proper diagnosis and early intervention,” said Dr. Lorraine Fitzpatrick, Radius Health’s Chief Medical Officer. “Patients who have had a fracture are at a five-fold risk of a subsequent fracture and reducing fracture risk should be the goal of treatment.” “We are extremely pleased with the results of the landmark ACTIVExtend trial which provides physicians, payers and patients with new insights into a treatment paradigm which targets building bone with an anabolic first line and then extending the benefit of fracture risk reduction with a low cost antiresorptive agent,” said Dr. Bruce Mitlak, Radius Health’s Vice President of Clinical Development. “The results from this program demonstrate that TYMLOS followed by alendronate can support this paradigm with sustained fracture risk reduction through 3.5 years.” Live webcast: http://edge.media-server.com/m/p/ys3pw2u9  A live webcast will also be available on the Investors section of the Company's website under Events & Presentations, www.radiuspharm.com.  A webcast replay will be available until June 30, 2017 on the Radius website as well as a copy of the presentation, www.radiuspharm.com. TYMLOS (abaloparatide) was approved by the U.S. Food and Drug Administration or 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' Marketing Authorisation Application (MAA) for abaloparatide-SC for the treatment of women with postmenopausal osteoporosis was validated and is currently undergoing regulatory review by the European Medicines Agency (EMA). Radius also is developing abaloparatide-transdermal (abaloparatide-TD) based on 3M's patented Microstructured Transdermal System technology for potential use as a treatment for postmenopausal women with osteoporosis. The Phase 3 ACTIVE (Abaloparatide Comparator Trial In Vertebral Endpoints) trial was a randomized, double-blind, placebo-controlled, comparative, multicenter, 18 month international study in 2,463 postmenopausal women with osteoporosis designed to evaluate the efficacy and safety of abaloparatide-SC 80 mcg to reduce the risk of vertebral and nonvertebral fractures. The results of ACTIVE were published in the Journal of the American Medical Association in August of 2016. ACTIVExtend, an extension of ACTIVE, enrolled patients who had completed 18 months of abaloparatide-SC or placebo in ACTIVE to receive up to 24 additional months of open-label alendronate. The results of the first six months of ACTIVExtend were published in the Mayo Clinic Proceedings in February of 2017. About “Together with TYMLOS” Program TYMLOS will be available in the United States in June. For eligible patients, Radius Health will offer the “Together with TYMLOS” support program. For more information please visit www.togetherwithTYMLOS.com or call 1-866-TYMLOS4 (1-866-896-5674) between 8 am and 8 pm EST, Monday through Friday. Orthostatic Hypotension: Orthostatic hypotension may occur with TYMLOS, typically within 4 hours of injection. Associated symptoms may include dizziness, palpitations, tachycardia or nausea, and may resolve by having the patient lie down. For the first several doses, TYMLOS should be administered where the patient can sit or lie down if necessary. Hypercalcemia: TYMLOS may cause hypercalcemia. TYMLOS is not recommended in patients with pre-existing hypercalcemia or in patients who have an underlying hypercalcemic disorder, such as primary hyperparathyroidism, because of the possibility of exacerbating hypercalcemia. Hypercalciuria and Urolithiasis: TYMLOS may cause hypercalciuria. It is unknown whether TYMLOS may exacerbate urolithiasis in patients with active or a history of urolithiasis. If active urolithiasis or pre-existing hypercalciuria is suspected, measurement of urinary calcium excretion should be considered. Adverse Reactions: The most common adverse reactions (incidence ≥2%) are hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain and vertigo. INDICATIONS AND USAGE TYMLOS is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, TYMLOS reduces the risk of vertebral fractures and nonvertebral fractures. Because of the unknown relevance of the rodent osteosarcoma findings to humans, cumulative use of TYMLOS and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient’s lifetime is not recommended. Osteoporosis is a silent disease, often displaying no signs or symptoms until a fracture occurs, leaving the majority of patients undiagnosed and untreated, representing a high unmet medical need. Osteoporotic fractures create a significant healthcare burden. An estimated two million osteoporotic fractures occur annually in the United States, and this number is projected to grow to three million by 2025. The National Osteoporosis Foundation (NOF) has estimated that eight million women already have osteoporosis, and another approximately 44 million may have low bone mass placing them at increased risk for osteoporosis. The annual incidence of osteoporotic fractures is higher than that of stroke, heart attack and breast cancer combined; osteoporotic fractures also account for more hospitalizations and associated costs than cardiovascular disease and breast cancer. Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases. Radius' lead product, TYMLOS (abaloparatide) injection was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture in April 2017. Radius' Marketing Authorisation Application (MAA) for abaloparatide-SC for the treatment of postmenopausal women with osteoporosis is under regulatory review in Europe. The Radius clinical pipeline includes an investigational abaloparatide transdermal patch for potential use in postmenopausal women with osteoporosis and the investigational drug elacestrant (RAD1901) for potential use in hormone-driven and/or hormone-resistant breast cancer, and vasomotor symptoms in postmenopausal women. Radius' RAD140, a non-steroidal, selective androgen receptor modulator (SARM), is under investigation for potential use in hormone receptor positive breast cancer. For more information, please visit www.radiuspharm.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding expectations for TYMLOS (abaloparatide) including without limitation, expectations regarding the clinical significance of clinical trial data for TYMLOS, the expected timing for the U.S. availability of TYMLOS, and our plans to submit an sNDA for the ACTIVExtend study and present the study data at future conferences, the potential benefit of treatment with TYMLOS for postmenopausal women with osteoporosis, the progress of abaloparatide-SC in the regulatory process with the EMA, the incidence of osteoporotic fractures and the health burden associated with osteoporosis, and the potential clinical uses for the abaloparatide transdermal patch, elacestrant (RAD1901) and RAD140. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our dependence on the success of TYMLOS; risks related to competitive products; risks related to our ability to successfully commercialize TYMLOS, including the failure to achieve market acceptance of TYMLOS in the U.S. or in any market where it may be approved; the availability of coverage and risks related to pricing and reimbursement for TYMLOS; risks related to manufacturing and supply; risks related to intellectual property; risks related to establishing and maintaining an effective process for distribution of TYMLOS; the risk that the results of clinical trials of TYMLOS will not meet ex-U.S. regulatory requirements for approval or that ex-U.S. regulatory authorities may require additional data or further studies, including our inability to ensure that abaloparatide-SC will obtain regulatory approval in Europe; and the other important factors discussed under the caption "Risk Factors" in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on February 24, 2017, and in our other reports filed with the SEC, that could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release.  While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.


ACTIVExtend trial demonstrated sustained statistically significant fracture risk reduction through the 3.5 years of sequential therapy: TYMLOS followed by an antiresorptive Safety similar among all treatment groups with no cases of ONJ or AFF across the entire TYMLOS development program Planned sNDA submission of final ACTIVExtend study and presentation at future scientific conferences Company to Host Top Line Results and Launch Update Webcast Today (Wednesday, May 24, 2017) at 4:30 p.m. ET WALTHAM, Mass., May 24, 2017 (GLOBE NEWSWIRE) -- Radius Health, Inc. (Nasdaq:RDUS) a science-driven fully integrated biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, today announced positive top-line results from the completed 24 month ACTIVExtend trial, which met all of its primary and secondary endpoints. In ACTIVExtend, patients who had completed 18 months of TYMLOS (abaloparatide) injections or placebo in the ACTIVE Phase 3 trial were transitioned to receive 24 additional months of open-label alendronate. “There is a substantial unmet medical need among postmenopausal women with osteoporosis at high risk of a fracture and we believe that these women deserve access to proper diagnosis and early intervention,” said Dr. Lorraine Fitzpatrick, Radius Health’s Chief Medical Officer. “Patients who have had a fracture are at a five-fold risk of a subsequent fracture and reducing fracture risk should be the goal of treatment.” “We are extremely pleased with the results of the landmark ACTIVExtend trial which provides physicians, payers and patients with new insights into a treatment paradigm which targets building bone with an anabolic first line and then extending the benefit of fracture risk reduction with a low cost antiresorptive agent,” said Dr. Bruce Mitlak, Radius Health’s Vice President of Clinical Development. “The results from this program demonstrate that TYMLOS followed by alendronate can support this paradigm with sustained fracture risk reduction through 3.5 years.” Live webcast: http://edge.media-server.com/m/p/ys3pw2u9  A live webcast will also be available on the Investors section of the Company's website under Events & Presentations, www.radiuspharm.com.  A webcast replay will be available until June 30, 2017 on the Radius website as well as a copy of the presentation, www.radiuspharm.com. TYMLOS (abaloparatide) was approved by the U.S. Food and Drug Administration or 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' Marketing Authorisation Application (MAA) for abaloparatide-SC for the treatment of women with postmenopausal osteoporosis was validated and is currently undergoing regulatory review by the European Medicines Agency (EMA). Radius also is developing abaloparatide-transdermal (abaloparatide-TD) based on 3M's patented Microstructured Transdermal System technology for potential use as a treatment for postmenopausal women with osteoporosis. The Phase 3 ACTIVE (Abaloparatide Comparator Trial In Vertebral Endpoints) trial was a randomized, double-blind, placebo-controlled, comparative, multicenter, 18 month international study in 2,463 postmenopausal women with osteoporosis designed to evaluate the efficacy and safety of abaloparatide-SC 80 mcg to reduce the risk of vertebral and nonvertebral fractures. The results of ACTIVE were published in the Journal of the American Medical Association in August of 2016. ACTIVExtend, an extension of ACTIVE, enrolled patients who had completed 18 months of abaloparatide-SC or placebo in ACTIVE to receive up to 24 additional months of open-label alendronate. The results of the first six months of ACTIVExtend were published in the Mayo Clinic Proceedings in February of 2017. About “Together with TYMLOS” Program TYMLOS will be available in the United States in June. For eligible patients, Radius Health will offer the “Together with TYMLOS” support program. For more information please visit www.togetherwithTYMLOS.com or call 1-866-TYMLOS4 (1-866-896-5674) between 8 am and 8 pm EST, Monday through Friday. Orthostatic Hypotension: Orthostatic hypotension may occur with TYMLOS, typically within 4 hours of injection. Associated symptoms may include dizziness, palpitations, tachycardia or nausea, and may resolve by having the patient lie down. For the first several doses, TYMLOS should be administered where the patient can sit or lie down if necessary. Hypercalcemia: TYMLOS may cause hypercalcemia. TYMLOS is not recommended in patients with pre-existing hypercalcemia or in patients who have an underlying hypercalcemic disorder, such as primary hyperparathyroidism, because of the possibility of exacerbating hypercalcemia. Hypercalciuria and Urolithiasis: TYMLOS may cause hypercalciuria. It is unknown whether TYMLOS may exacerbate urolithiasis in patients with active or a history of urolithiasis. If active urolithiasis or pre-existing hypercalciuria is suspected, measurement of urinary calcium excretion should be considered. Adverse Reactions: The most common adverse reactions (incidence ≥2%) are hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain and vertigo. INDICATIONS AND USAGE TYMLOS is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, TYMLOS reduces the risk of vertebral fractures and nonvertebral fractures. Because of the unknown relevance of the rodent osteosarcoma findings to humans, cumulative use of TYMLOS and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient’s lifetime is not recommended. Osteoporosis is a silent disease, often displaying no signs or symptoms until a fracture occurs, leaving the majority of patients undiagnosed and untreated, representing a high unmet medical need. Osteoporotic fractures create a significant healthcare burden. An estimated two million osteoporotic fractures occur annually in the United States, and this number is projected to grow to three million by 2025. The National Osteoporosis Foundation (NOF) has estimated that eight million women already have osteoporosis, and another approximately 44 million may have low bone mass placing them at increased risk for osteoporosis. The annual incidence of osteoporotic fractures is higher than that of stroke, heart attack and breast cancer combined; osteoporotic fractures also account for more hospitalizations and associated costs than cardiovascular disease and breast cancer. Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases. Radius' lead product, TYMLOS (abaloparatide) injection was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture in April 2017. Radius' Marketing Authorisation Application (MAA) for abaloparatide-SC for the treatment of postmenopausal women with osteoporosis is under regulatory review in Europe. The Radius clinical pipeline includes an investigational abaloparatide transdermal patch for potential use in postmenopausal women with osteoporosis and the investigational drug elacestrant (RAD1901) for potential use in hormone-driven and/or hormone-resistant breast cancer, and vasomotor symptoms in postmenopausal women. Radius' RAD140, a non-steroidal, selective androgen receptor modulator (SARM), is under investigation for potential use in hormone receptor positive breast cancer. For more information, please visit www.radiuspharm.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding expectations for TYMLOS (abaloparatide) including without limitation, expectations regarding the clinical significance of clinical trial data for TYMLOS, the expected timing for the U.S. availability of TYMLOS, and our plans to submit an sNDA for the ACTIVExtend study and present the study data at future conferences, the potential benefit of treatment with TYMLOS for postmenopausal women with osteoporosis, the progress of abaloparatide-SC in the regulatory process with the EMA, the incidence of osteoporotic fractures and the health burden associated with osteoporosis, and the potential clinical uses for the abaloparatide transdermal patch, elacestrant (RAD1901) and RAD140. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our dependence on the success of TYMLOS; risks related to competitive products; risks related to our ability to successfully commercialize TYMLOS, including the failure to achieve market acceptance of TYMLOS in the U.S. or in any market where it may be approved; the availability of coverage and risks related to pricing and reimbursement for TYMLOS; risks related to manufacturing and supply; risks related to intellectual property; risks related to establishing and maintaining an effective process for distribution of TYMLOS; the risk that the results of clinical trials of TYMLOS will not meet ex-U.S. regulatory requirements for approval or that ex-U.S. regulatory authorities may require additional data or further studies, including our inability to ensure that abaloparatide-SC will obtain regulatory approval in Europe; and the other important factors discussed under the caption "Risk Factors" in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on February 24, 2017, and in our other reports filed with the SEC, that could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release.  While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.


ACTIVExtend trial demonstrated sustained statistically significant fracture risk reduction through the 3.5 years of sequential therapy: TYMLOS followed by an antiresorptive Safety similar among all treatment groups with no cases of ONJ or AFF across the entire TYMLOS development program Planned sNDA submission of final ACTIVExtend study and presentation at future scientific conferences Company to Host Top Line Results and Launch Update Webcast Today (Wednesday, May 24, 2017) at 4:30 p.m. ET WALTHAM, Mass., May 24, 2017 (GLOBE NEWSWIRE) -- Radius Health, Inc. (Nasdaq:RDUS) a science-driven fully integrated biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, today announced positive top-line results from the completed 24 month ACTIVExtend trial, which met all of its primary and secondary endpoints. In ACTIVExtend, patients who had completed 18 months of TYMLOS (abaloparatide) injections or placebo in the ACTIVE Phase 3 trial were transitioned to receive 24 additional months of open-label alendronate. “There is a substantial unmet medical need among postmenopausal women with osteoporosis at high risk of a fracture and we believe that these women deserve access to proper diagnosis and early intervention,” said Dr. Lorraine Fitzpatrick, Radius Health’s Chief Medical Officer. “Patients who have had a fracture are at a five-fold risk of a subsequent fracture and reducing fracture risk should be the goal of treatment.” “We are extremely pleased with the results of the landmark ACTIVExtend trial which provides physicians, payers and patients with new insights into a treatment paradigm which targets building bone with an anabolic first line and then extending the benefit of fracture risk reduction with a low cost antiresorptive agent,” said Dr. Bruce Mitlak, Radius Health’s Vice President of Clinical Development. “The results from this program demonstrate that TYMLOS followed by alendronate can support this paradigm with sustained fracture risk reduction through 3.5 years.” Live webcast: http://edge.media-server.com/m/p/ys3pw2u9  A live webcast will also be available on the Investors section of the Company's website under Events & Presentations, www.radiuspharm.com.  A webcast replay will be available until June 30, 2017 on the Radius website as well as a copy of the presentation, www.radiuspharm.com. TYMLOS (abaloparatide) was approved by the U.S. Food and Drug Administration or 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' Marketing Authorisation Application (MAA) for abaloparatide-SC for the treatment of women with postmenopausal osteoporosis was validated and is currently undergoing regulatory review by the European Medicines Agency (EMA). Radius also is developing abaloparatide-transdermal (abaloparatide-TD) based on 3M's patented Microstructured Transdermal System technology for potential use as a treatment for postmenopausal women with osteoporosis. The Phase 3 ACTIVE (Abaloparatide Comparator Trial In Vertebral Endpoints) trial was a randomized, double-blind, placebo-controlled, comparative, multicenter, 18 month international study in 2,463 postmenopausal women with osteoporosis designed to evaluate the efficacy and safety of abaloparatide-SC 80 mcg to reduce the risk of vertebral and nonvertebral fractures. The results of ACTIVE were published in the Journal of the American Medical Association in August of 2016. ACTIVExtend, an extension of ACTIVE, enrolled patients who had completed 18 months of abaloparatide-SC or placebo in ACTIVE to receive up to 24 additional months of open-label alendronate. The results of the first six months of ACTIVExtend were published in the Mayo Clinic Proceedings in February of 2017. About “Together with TYMLOS” Program TYMLOS will be available in the United States in June. For eligible patients, Radius Health will offer the “Together with TYMLOS” support program. For more information please visit www.togetherwithTYMLOS.com or call 1-866-TYMLOS4 (1-866-896-5674) between 8 am and 8 pm EST, Monday through Friday. Orthostatic Hypotension: Orthostatic hypotension may occur with TYMLOS, typically within 4 hours of injection. Associated symptoms may include dizziness, palpitations, tachycardia or nausea, and may resolve by having the patient lie down. For the first several doses, TYMLOS should be administered where the patient can sit or lie down if necessary. Hypercalcemia: TYMLOS may cause hypercalcemia. TYMLOS is not recommended in patients with pre-existing hypercalcemia or in patients who have an underlying hypercalcemic disorder, such as primary hyperparathyroidism, because of the possibility of exacerbating hypercalcemia. Hypercalciuria and Urolithiasis: TYMLOS may cause hypercalciuria. It is unknown whether TYMLOS may exacerbate urolithiasis in patients with active or a history of urolithiasis. If active urolithiasis or pre-existing hypercalciuria is suspected, measurement of urinary calcium excretion should be considered. Adverse Reactions: The most common adverse reactions (incidence ≥2%) are hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain and vertigo. INDICATIONS AND USAGE TYMLOS is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, TYMLOS reduces the risk of vertebral fractures and nonvertebral fractures. Because of the unknown relevance of the rodent osteosarcoma findings to humans, cumulative use of TYMLOS and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient’s lifetime is not recommended. Osteoporosis is a silent disease, often displaying no signs or symptoms until a fracture occurs, leaving the majority of patients undiagnosed and untreated, representing a high unmet medical need. Osteoporotic fractures create a significant healthcare burden. An estimated two million osteoporotic fractures occur annually in the United States, and this number is projected to grow to three million by 2025. The National Osteoporosis Foundation (NOF) has estimated that eight million women already have osteoporosis, and another approximately 44 million may have low bone mass placing them at increased risk for osteoporosis. The annual incidence of osteoporotic fractures is higher than that of stroke, heart attack and breast cancer combined; osteoporotic fractures also account for more hospitalizations and associated costs than cardiovascular disease and breast cancer. Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases. Radius' lead product, TYMLOS (abaloparatide) injection was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture in April 2017. Radius' Marketing Authorisation Application (MAA) for abaloparatide-SC for the treatment of postmenopausal women with osteoporosis is under regulatory review in Europe. The Radius clinical pipeline includes an investigational abaloparatide transdermal patch for potential use in postmenopausal women with osteoporosis and the investigational drug elacestrant (RAD1901) for potential use in hormone-driven and/or hormone-resistant breast cancer, and vasomotor symptoms in postmenopausal women. Radius' RAD140, a non-steroidal, selective androgen receptor modulator (SARM), is under investigation for potential use in hormone receptor positive breast cancer. For more information, please visit www.radiuspharm.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding expectations for TYMLOS (abaloparatide) including without limitation, expectations regarding the clinical significance of clinical trial data for TYMLOS, the expected timing for the U.S. availability of TYMLOS, and our plans to submit an sNDA for the ACTIVExtend study and present the study data at future conferences, the potential benefit of treatment with TYMLOS for postmenopausal women with osteoporosis, the progress of abaloparatide-SC in the regulatory process with the EMA, the incidence of osteoporotic fractures and the health burden associated with osteoporosis, and the potential clinical uses for the abaloparatide transdermal patch, elacestrant (RAD1901) and RAD140. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our dependence on the success of TYMLOS; risks related to competitive products; risks related to our ability to successfully commercialize TYMLOS, including the failure to achieve market acceptance of TYMLOS in the U.S. or in any market where it may be approved; the availability of coverage and risks related to pricing and reimbursement for TYMLOS; risks related to manufacturing and supply; risks related to intellectual property; risks related to establishing and maintaining an effective process for distribution of TYMLOS; the risk that the results of clinical trials of TYMLOS will not meet ex-U.S. regulatory requirements for approval or that ex-U.S. regulatory authorities may require additional data or further studies, including our inability to ensure that abaloparatide-SC will obtain regulatory approval in Europe; and the other important factors discussed under the caption "Risk Factors" in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on February 24, 2017, and in our other reports filed with the SEC, that could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release.  While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.


ACTIVExtend trial demonstrated sustained statistically significant fracture risk reduction through the 3.5 years of sequential therapy: TYMLOS followed by an antiresorptive Safety similar among all treatment groups with no cases of ONJ or AFF across the entire TYMLOS development program Planned sNDA submission of final ACTIVExtend study and presentation at future scientific conferences Company to Host Top Line Results and Launch Update Webcast Today (Wednesday, May 24, 2017) at 4:30 p.m. ET WALTHAM, Mass., May 24, 2017 (GLOBE NEWSWIRE) -- Radius Health, Inc. (Nasdaq:RDUS) a science-driven fully integrated biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, today announced positive top-line results from the completed 24 month ACTIVExtend trial, which met all of its primary and secondary endpoints. In ACTIVExtend, patients who had completed 18 months of TYMLOS (abaloparatide) injections or placebo in the ACTIVE Phase 3 trial were transitioned to receive 24 additional months of open-label alendronate. “There is a substantial unmet medical need among postmenopausal women with osteoporosis at high risk of a fracture and we believe that these women deserve access to proper diagnosis and early intervention,” said Dr. Lorraine Fitzpatrick, Radius Health’s Chief Medical Officer. “Patients who have had a fracture are at a five-fold risk of a subsequent fracture and reducing fracture risk should be the goal of treatment.” “We are extremely pleased with the results of the landmark ACTIVExtend trial which provides physicians, payers and patients with new insights into a treatment paradigm which targets building bone with an anabolic first line and then extending the benefit of fracture risk reduction with a low cost antiresorptive agent,” said Dr. Bruce Mitlak, Radius Health’s Vice President of Clinical Development. “The results from this program demonstrate that TYMLOS followed by alendronate can support this paradigm with sustained fracture risk reduction through 3.5 years.” Live webcast: http://edge.media-server.com/m/p/ys3pw2u9  A live webcast will also be available on the Investors section of the Company's website under Events & Presentations, www.radiuspharm.com.  A webcast replay will be available until June 30, 2017 on the Radius website as well as a copy of the presentation, www.radiuspharm.com. TYMLOS (abaloparatide) was approved by the U.S. Food and Drug Administration or 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' Marketing Authorisation Application (MAA) for abaloparatide-SC for the treatment of women with postmenopausal osteoporosis was validated and is currently undergoing regulatory review by the European Medicines Agency (EMA). Radius also is developing abaloparatide-transdermal (abaloparatide-TD) based on 3M's patented Microstructured Transdermal System technology for potential use as a treatment for postmenopausal women with osteoporosis. The Phase 3 ACTIVE (Abaloparatide Comparator Trial In Vertebral Endpoints) trial was a randomized, double-blind, placebo-controlled, comparative, multicenter, 18 month international study in 2,463 postmenopausal women with osteoporosis designed to evaluate the efficacy and safety of abaloparatide-SC 80 mcg to reduce the risk of vertebral and nonvertebral fractures. The results of ACTIVE were published in the Journal of the American Medical Association in August of 2016. ACTIVExtend, an extension of ACTIVE, enrolled patients who had completed 18 months of abaloparatide-SC or placebo in ACTIVE to receive up to 24 additional months of open-label alendronate. The results of the first six months of ACTIVExtend were published in the Mayo Clinic Proceedings in February of 2017. About “Together with TYMLOS” Program TYMLOS will be available in the United States in June. For eligible patients, Radius Health will offer the “Together with TYMLOS” support program. For more information please visit www.togetherwithTYMLOS.com or call 1-866-TYMLOS4 (1-866-896-5674) between 8 am and 8 pm EST, Monday through Friday. Orthostatic Hypotension: Orthostatic hypotension may occur with TYMLOS, typically within 4 hours of injection. Associated symptoms may include dizziness, palpitations, tachycardia or nausea, and may resolve by having the patient lie down. For the first several doses, TYMLOS should be administered where the patient can sit or lie down if necessary. Hypercalcemia: TYMLOS may cause hypercalcemia. TYMLOS is not recommended in patients with pre-existing hypercalcemia or in patients who have an underlying hypercalcemic disorder, such as primary hyperparathyroidism, because of the possibility of exacerbating hypercalcemia. Hypercalciuria and Urolithiasis: TYMLOS may cause hypercalciuria. It is unknown whether TYMLOS may exacerbate urolithiasis in patients with active or a history of urolithiasis. If active urolithiasis or pre-existing hypercalciuria is suspected, measurement of urinary calcium excretion should be considered. Adverse Reactions: The most common adverse reactions (incidence ≥2%) are hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain and vertigo. INDICATIONS AND USAGE TYMLOS is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, TYMLOS reduces the risk of vertebral fractures and nonvertebral fractures. Because of the unknown relevance of the rodent osteosarcoma findings to humans, cumulative use of TYMLOS and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient’s lifetime is not recommended. Osteoporosis is a silent disease, often displaying no signs or symptoms until a fracture occurs, leaving the majority of patients undiagnosed and untreated, representing a high unmet medical need. Osteoporotic fractures create a significant healthcare burden. An estimated two million osteoporotic fractures occur annually in the United States, and this number is projected to grow to three million by 2025. The National Osteoporosis Foundation (NOF) has estimated that eight million women already have osteoporosis, and another approximately 44 million may have low bone mass placing them at increased risk for osteoporosis. The annual incidence of osteoporotic fractures is higher than that of stroke, heart attack and breast cancer combined; osteoporotic fractures also account for more hospitalizations and associated costs than cardiovascular disease and breast cancer. Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases. Radius' lead product, TYMLOS (abaloparatide) injection was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture in April 2017. Radius' Marketing Authorisation Application (MAA) for abaloparatide-SC for the treatment of postmenopausal women with osteoporosis is under regulatory review in Europe. The Radius clinical pipeline includes an investigational abaloparatide transdermal patch for potential use in postmenopausal women with osteoporosis and the investigational drug elacestrant (RAD1901) for potential use in hormone-driven and/or hormone-resistant breast cancer, and vasomotor symptoms in postmenopausal women. Radius' RAD140, a non-steroidal, selective androgen receptor modulator (SARM), is under investigation for potential use in hormone receptor positive breast cancer. For more information, please visit www.radiuspharm.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding expectations for TYMLOS (abaloparatide) including without limitation, expectations regarding the clinical significance of clinical trial data for TYMLOS, the expected timing for the U.S. availability of TYMLOS, and our plans to submit an sNDA for the ACTIVExtend study and present the study data at future conferences, the potential benefit of treatment with TYMLOS for postmenopausal women with osteoporosis, the progress of abaloparatide-SC in the regulatory process with the EMA, the incidence of osteoporotic fractures and the health burden associated with osteoporosis, and the potential clinical uses for the abaloparatide transdermal patch, elacestrant (RAD1901) and RAD140. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our dependence on the success of TYMLOS; risks related to competitive products; risks related to our ability to successfully commercialize TYMLOS, including the failure to achieve market acceptance of TYMLOS in the U.S. or in any market where it may be approved; the availability of coverage and risks related to pricing and reimbursement for TYMLOS; risks related to manufacturing and supply; risks related to intellectual property; risks related to establishing and maintaining an effective process for distribution of TYMLOS; the risk that the results of clinical trials of TYMLOS will not meet ex-U.S. regulatory requirements for approval or that ex-U.S. regulatory authorities may require additional data or further studies, including our inability to ensure that abaloparatide-SC will obtain regulatory approval in Europe; and the other important factors discussed under the caption "Risk Factors" in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on February 24, 2017, and in our other reports filed with the SEC, that could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release.  While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.


DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Bone Densitometers Market, 2014-2025" report to their offering. The global bone densitometers market is expected to reach USD 1.2 billion by 2025. The growing prevalence of metabolic bone diseases is believed to be responsible for the high clinical urgency to adopt bone densitometers, thereby impelling the market demand. Growing base of geriatric and obese population, which is highly susceptible to developing disorders such as osteoporosis, is anticipated to propel the demand further. The aforementioned factors are slated to present the market with lucrative growth opportunities over the coming years. Moreover, presence of consistent number of health initiatives to promote awareness pertaining to osteoporosis is anticipated to broaden market growth potential over the coming years. For instance, National Osteoporosis Foundation (NOF), a government healthcare organization that conducts National Bone Health Alliance and Fracture Liaison Service (FLS) care coordination programs, is focused on elevating awareness levels pertaining to available diagnostic & treatment alternatives for osteoporosis. It also encourages training of healthcare professionals for efficient management of osteoporosis. In addition, advent of technologically advanced devices, such as portable densitometers, is presumed to fuel their adoption in home healthcare. Other technological advancements include implementation of advanced hip assessment software into DXA systems that enabled noninvasive assessment of proximal femur structural geometry. Additional associated benefits include depiction of wide array of parameters such as skeletal mapping, hip axis length assessment, areal BMD determination, and cross-sectional area & the femoral strength index. For more information about this report visit http://www.researchandmarkets.com/research/7szhvr/bone


The global osteoporosis drugs market is expected to reach USD 16.3 billion by 2025 An upsurge rise in the unhealthy lifestyle adoption has resulted in aggravation and increase in the prevalence of osteoporosis which is presumed to propel the osteoporosis drugs market during the forecast period. In addition, growing number of patent expiries is fueling the high clinical urgency to use generic versions of the established drugs, which is presumed to fuel generic osteoporosis drugs market during the forecast period. The aforementioned factors cumulatively are slated to present the with high potential growth opportunities over the coming years. Furthermore, rising number of initiatives to increase the awareness levels pertaining to osteoporosis care amongst the patients as well as the physicians is expected to widen the osteoporosis market growth potential during the forecast period. For instance, National Osteoporosis Foundation (NOF), a healthcare organization responsible for National Bone Health Alliance and Fracture Liaison Service (FLS) care coordination programs that focuses on elevating awareness levels as well as provides training to healthcare professionals Further key findings from the study suggest: For more information about this report visit http://www.researchandmarkets.com/research/dlf8sz/osteoporosis To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/global-osteoporosis-drugs-market-analysis-2014-2017--2025-market-is-expected-to-reach-usd-163-billion---research-and-markets-300444093.html


News Article | May 1, 2017
Site: www.prnewswire.com

To prevent osteoporosis, you must build the strongest and densest bone you can early in life. You develop what is known as "peak bone mass" between the ages of 25-30, after that you break down bone at a faster rate than you build it. It's important to consume a healthy diet, including adequate calcium and vitamin D, and do weight-bearing and muscle-strengthening exercises to build peak bone mass and to maintain your bone strength throughout your lifetime. "We know osteoporosis causes two million broken bones every year in the U.S., yet the majority of Americans don't realize how important their bone health is until they have a debilitating fracture," said Amy Porter, executive director and CEO, National Osteoporosis Foundation. "That's why we're encouraging everyone to Break Free from Osteoporosis and accept our Jumping Jack Challenge to ensure people of ALL ages know how important good bone health really is." Jumping jacks are a recommended activity for building strong bones and helping to achieve Peak Bone Mass early in life. The Jumping Jack Challenge asks you to film yourself or your family or friends doing 10 jumping jacks in less than 10 seconds. Post the video to social media tagging your friends and asking them to take the Jumping Jack Challenge. If they don't accept the challenge, ask that they make a donation to NOF to help raise awareness and support research in bone health.  Use the hashtag #JumpingJackChallenge to help spread the word. Throughout the month of May, NOF will provide webinars and resources to healthcare professionals and the public with tips on building and maintaining bone health as well as diagnosing and treating osteoporosis. These free downloadable materials and webinar registration links can be found on the NOF website at www.nof.org. Established in 1984, the National Osteoporosis Foundation is the nation's leading health organization dedicated to preventing osteoporosis and broken bones, promoting strong bones for life and reducing human suffering through programs of awareness, education, advocacy and research. For more information on the National Osteoporosis Foundation, visit www.nof.org. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/how-strong-are-your-bones-may-is-national-osteoporosis-month-300448615.html


Yoshinaga K.,Tsukishima Foods Industry Co | Sato S.,Japan Food Research Laboratories | Sasaki R.,Miyoshi Oil and Fat Co | Asada M.,Showa Sangyo Co | And 12 more authors.
Journal of Oleo Science | Year: 2016

The positional distributions of fatty acids (FAs) in milk fat containing short- and medium-chain FAs were analyzed by sn-1(3)-selective transesterification of triacylglycerols (TAGs) with ethanol using immobilized Candida antarctica lipase B (CALB), in a collaborative study conducted by 10 laboratories. The mean C4:0, C6:0, and C8:0 FA contents, when analyzed as propyl esters (PEs) using gas chromatography (GC) with a DB-23 capillary column, were found to be 3.0, 2.0, and, 1.3 area%, respectively. Their reproducibility standard deviations were 0.33, 0.18, and 0.19, respectively. The mean C4:0, C6:0, and C8:0 contents at the sn-2 position were 0.3, 0.4, and 1.0 area%, respectively. Their reproducibility standard deviations were 0.17, 0.11, and 0.19, respectively. The reproducibility standard deviations of C4:0, C6:0, and C8:0 FAs at the sn-2 position were either the same as or smaller than those for milk fat, although the FA contents at the sn-2 position were smaller than those in the milk fat. Therefore, it was concluded that the CALB method for estimating the regiospecific distribution is applicable to TAGs containing short- and medium-chain FAs. When estimating the short-chain (SC) FA contents in fats and oils by GC, it is better to analyze SCFAs as PEs or butyl esters, and not as methyl esters, in order to prevent loss of SCFAs during the experimental procedure because of their volatility and water solubility. This study also revealed that the stationary phase of the GC capillary column affected the flame ionization detector (FID) response of SCFAs. The theoretical FID correction factor (MWFA/active carbon number/atomic weight of carbon) fitted well with the actual FID responses of C4:0-C12:0 FAs when they were analyzed as PEs using a DB-23 column; however, this was not the case when the GC analysis was performed using wax-type columns. © 2016 by Japan Oil Chemists’ Society.


Sakai H.,Tokyo University of Science | Aikawa S.,Tokyo University of Science | Matsuda W.,Tokyo University of Science | Ohmori T.,Shiseido Co. | And 10 more authors.
Journal of Colloid and Interface Science | Year: 2012

We have developed a novel cinnamic acid-type photo-cleavable surfactant. This surfactant experiences photo-cleavage through UV-induced cyclization in aqueous solutions. The photo-cleavage not only reduces its capabilities as a surfactant but also yields two functional materials including a coumarin derivative and an aminated polyoxyethylene compound. This means that the photo-cleavable surfactant synthesized in this study is a photo-responsive function-exchangeable material. In our current study, we have characterized the photo-cleavable behavior that occurs in aqueous solutions and a resulting change in interfacial properties. The photo-cleavage induces an increased interfacial tension of a squalane/water interface and a decreased solubilization capability of the surfactant micelles. © 2012 Elsevier Inc.


Aikawa S.,Tokyo University of Science | Shrestha R.G.,Tokyo University of Science | Ohmori T.,Shiseido Co. | Fukukita Y.,Shiseido Co. | And 8 more authors.
Langmuir | Year: 2013

Recently, we have reported a new cinnamic acid-type photocleavable surfactant, C4-C-N-PEG9 that experiences a photocleavage through UV-induced cyclization in aqueous solution, yielding a coumarin derivative (7-butoxy-2H-chromen-2-one) and an aminated polyoxyethylene compound. Here, we have studied the effects of C4-C-N-PEG9 on the photorheological behavior of viscoelastic wormlike micelles formed by aqueous mixture of nonionic surfactants, polyoxyethylene phytosterol ether (PhyEO20) and tetraoxyethylene dodecyl ether (C12EO4). The 4.9 wt % PhyEO20/H2O + 2.4 wt % C12EO4 solution forms wormlike micelles, and its viscosity is ∼10 Pa·s. We have found that the addition of C4-C-N-PEG9 into this viscous, non-Newtonian fluid system decreases the viscosity. Viscosity decreased in parallel to the C4-C-N-PEG9 concentration reaching ∼0.003 Pa·s at 2.5 wt % of C4-C-N-PEG9. However, viscosity of the C4-C-N-PEG9 incorporated system increased significantly (∼200 times at 1.5 wt % of C4-C-N-PEG9 system) upon UV irradiation. Small-Angle X-ray scattering studies have shown that addition of C4-C-N-PEG9 favors wormlike-to-sphere type transition in the micellar structure. However, UV irradiation in the C4-C-N-PEG9 incorporated system causes one-dimensional micellar growth. Since C4-C-N-PEG9 has relatively bigger headgroup size compared to the C12EO4, addition of C4-C-N-PEG9 into wormlike micelles reduces the critical packing parameter resulting in the formation of spherical aggregates. UV irradiation induced one-dimensional micellar growth is caused due to photocleavage of the C4-C-N-PEG9 into a less surface-active coumarin derivative and an aminated polyoxyethylene compound, as confirmed by UV-vis spectrometry and HPLC measurements. The hydrophobic coumarin derivative formed after cleavage of C4-C-N-PEG9 goes to the micellar core and is responsible for decreasing the viscosity. However, the hydrophilic aminated polyoxyethylene prefers to reside at the vicinity of headgroup of PhyEO20 reducing the interhead repulsion, increasing the critical packing parameter and the viscosity as well. © 2013 American Chemical Society.

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