Five posters will cover new data on the need for osteoporosis awareness as well as cost-effectiveness data on treatment with TYMLOS
WALTHAM, Mass., Oct. 13, 2017 (GLOBE NEWSWIRE) -- Radius Health, Inc. (Nasdaq: RDUS ), a science-driven biopharmaceutical company committed to developing and commercializing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, will present five posters focusing on the Company’s Health Economics and Outcomes Research (HEOR) data regarding the treatment of osteoporosis within the U.S. healthcare system at the Academy of Managed Care Pharmacy (AMCP) Nexus 2017 Meeting in Dallas, TX from October 16-19, 2017.
“Osteoporosis-related fractures are a serious public health burden that could lead to excess morbidity and mortality, resulting in high costs for post-fracture care,” said Lorraine Fitzpatrick, MD, Chief Medical Officer, Radius Health. “We are pleased to share data at AMCP that demonstrate the high number of osteoporotic fractures that occur and support the need to prioritize the management of postmenopausal osteoporosis. Cost-effectiveness is an important consideration in the payer value assessment framework.” Radius’ health economics data delivered at the meeting support the need to raise patient awareness of the relationship between a fragility fracture and increased future fracture risk, which drives the overall cost of illness.
The following posters will be presented on Wednesday, October 18 from noon - 2:45 p.m. CST at the Gaylord Texan Hotel & Convention Center:
- Osteoporosis-Related Fracture Events in the U.S.
- Deane Leader Jr., Setareh A. Williams, Jeffrey R. Curtis, Robert Gut
- Challenges in Osteoporosis Awareness and Management: Results from a Survey of U.S. Postmenopausal Women
- E. Michael Lewiecki, Setareh A. Williams, Robert Gut
- Cost-Effectiveness of Abaloparatide vs. Teriparatide for Prevention of Osteoporosis-Related Fracture: A U.S. Payer Perspective
- Joel Hay, Quang Le, Yamei Wang
- Cost-Effectiveness of Abaloparatide for the Treatment of Postmenopausal Women with Osteoporosis
- Mickael Hiligsmann, Setareh A. Williams, Jean-Yves Reginster
- The Number-Needed-to-Treat to Prevent a Fragility Fracture: Comparison of Abaloparatide-SC and Teriparatide
- Jean-Yves Reginster, Dennis M. Black, Gary Hattersley, Gregory Williams, Lorraine A. Fitzpatrick, E. Michael Lewiecki
Radius has taken a responsible approach to pricing TYMLOS and considered factors such as the unmet need, total cost of care and affordability at the patient level.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF OSTEOSARCOMA
- Abaloparatide caused a dose-dependent increase in the incidence of osteosarcoma (a malignant bone tumor) in male and female rats. The effect was observed at systemic exposures to abaloparatide ranging from 4 to 28 times the exposure in humans receiving the 80-mcg dose. It is unknown if TYMLOS will cause osteosarcoma in humans.
- The use of TYMLOS is not recommended in patients at increased risk of osteosarcoma including those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, open epiphyses, bone metastases or skeletal malignancies, hereditary disorders predisposing to osteosarcoma, or prior external beam or implant radiation therapy involving the skeleton.
- Cumulative use of TYMLOS and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient's lifetime is not recommended.
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.
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 Postmenopausal Osteoporosis
Osteoporosis is a silent disease, often displaying no signs or symptoms until a fracture occurs, leaving a majority of patients undiagnosed and undertreated. Osteoporotic fractures create a significant healthcare burden, and represent a significant unmet medical need. The majority of osteoporosis-related fractures in the U.S. among those 50 and older (71 percent) occur in women.
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)
TYMLOS (abaloparatide) was approved in April 2017 by the U.S. Food and Drug Administration 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' 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.
About Radius
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. Radius’ clinical pipeline includes an investigational abaloparatide transdermal patch for potential use in osteoporosis; the investigational drug elacestrant (RAD1901) for potential use in hormone-driven and/or hormone-resistant breast cancer, and vasomotor symptoms in postmenopausal women; and RAD140, a non-steroidal, selective androgen receptor modulator (SARM) under investigation for potential use in hormone receptor positive breast cancer. For more information, please visit www.radiuspharm.com .
Forward-Looking Statements
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 of the significance of health economics data related to the treatment of osteoporosis and/or TYMLOS, the potential benefit and cost-effectiveness of treatment with TYMLOS for postmenopausal women with osteoporosis, the progress of abaloparatide-SC in the regulatory process with the EMA, and the potential clinical uses for abaloparatide-TD, 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: 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 and any collaboration agreements 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 most recent Quarterly Report on Form 10-Q 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
Tiffany H. Burke Email: tburke@radiuspharm.com Phone: 484-582-6476
