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Radius Health to Present Data on TYMLOS® (abaloparatide) Injection at ENDO 2019 Annual MeetingWALTHAM, Mass., March 18, 2019 (GLOBE NEWSWIRE) -- Radius Health, Inc. (Nasdaq: RDUS), a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine therapeutics in the areas of osteoporosis and oncology, today announced it will present data on TYMLOS® (abaloparatide) injection at ENDO 2019, the Endocrine Society’s Annual Meeting and Expo in New Orleans, LA. During an oral session, Radius Health will present two abstracts on abaloparatide injection: a post-hoc analysis in a subset of women from the Phase 3 ACTIVE trial who have both postmenopausal osteoporosis (PMO) and osteoarthritis, and data from preclinical studies that provide mechanistic explanations for the net bone gain observed in ACTIVE in abaloparatide-treated patients. Radius Health will also present a poster on the effect of abaloparatide in a subset of younger PMO women representative of covered commercial insurance enrollees considered to be at high risk for fracture and meeting potential criteria for coverage. “We continue to explore the data from different patient populations included in the Phase 3 ACTIVE trial of TYMLOS (abaloparatide) injection and look forward to sharing the results of these analyses with healthcare professionals at this important meeting,” said Dr. Charles Morris, Radius Health’s Chief Medical Officer. “Understanding the effects of abaloparatide in different populations is essential to the overall management of postmenopausal osteoporosis and these analyses continue to provide information that can inform important treatment decisions.” Radius Health Oral Presentations
Radius Health Poster Presentations
About Postmenopausal Osteoporosis The National Osteoporosis Foundation (NOF) has estimated that nearly 8.2 million women in the U.S. over the age of 50 have osteoporosis, and nearly one in two women over the age of 50 will have a fragility fracture (or low-impact fracture that is often the result of a fall from standing height or lower) in her remaining lifetime. 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. About TYMLOS (abaloparatide) injection About ACTIVE IMPORTANT SAFETY INFORMATION WARNING: RISK OF OSTEOSARCOMA
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 Limitations of Use 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. For the TYMLOS prescribing information, including Boxed Warning, please visit www.tymlospi.com. About Radius Forward-Looking Statements 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: we expect to need to raise additional funding, which may not be available; risks related to raising additional capital; our limited operating history; quarterly fluctuation in our financial results; our dependence on the success of TYMLOS, and our inability to ensure that TYMLOS will obtain regulatory approval outside the U.S. or be successfully commercialized in any market in which it is approved, including as a result of risk related to coverage, pricing and reimbursement; risks related to competitive products; risks related to our ability to successfully enter into collaboration agreements and any collaborations failing to be successful; risks related to clinical trials, including our reliance on third parties to conduct key portions of our clinical trials and uncertainty that results will support our product candidate claims; the risk that adverse side effects will be identified during the development of our product candidates or during commercialization, if approved; risks related to manufacturing, supply and distribution; and the risk of litigation or other challenges regarding our intellectual property rights. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ending December 31, 2018 and subsequent filings with the SEC, 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. Media Contact: |