Includes detailed results from Phase 2 histomorphometry study and Teijin’s Phase 3 trial in Japan
WALTHAM, Mass., September 9, 2020 (GLOBE NEWSWIRE) -- Radius Health, Inc. (“Radius” or the “Company”) (Nasdaq: RDUS) today announced data presentations on abaloparatide-SC at the upcoming American Society for Bone and Mineral Research (ASBMR) 2020 Annual Virtual Meeting which will take place between September 11-15.
“We are excited that data from our histomorphometry study, showing that treatment with abaloparatide results in significant increase in bone formation in postmenopausal women with osteoporosis after 3 months of treatment, has been selected as an oral presentation,” said Dr. Charles Morris, Radius Health’s Chief Medical Officer. “We are also excited that our partner Teijin Pharma Limited will be sharing detailed data from the Phase III clinical study of abaloparatide-SC in Japan which included osteoporosis patients at high risk for fracture and met its primary efficacy endpoint. Helping more women with postmenopausal osteoporosis at high risk for fracture is our ultimate goal.”
Abaloparatide-SC Presentations at ASBMR 2020
- Abaloparatide, A Novel Selective Agonist of PTH/PTHrP Receptor, Increases Lumbar, Total Hip and Femoral Neck BMD in Japanese Patients with Osteoporosis - A Phase III Randomized Clinical Trial ACTIVE-J (Matsumoto)
P-342; Friday, September 11, 10:00 AM - 04:00 PM
- Abaloparatide, A Novel Selective Agonist for PTH/PTHrP Receptor, Effectively Improved Hip Geometry and Biomechanical Properties Assessed by Hip Structural Analysis in Elderly Osteoporotic Patients - Results of the Japanese Phase 3 Trial, ACTIVE-J (Sone)
P-671; Friday, September 11, 10:00 AM - 04:00 PM
- Effects of Abaloparatide on Modeling and Remodeling Based Bone Formation (Dempster)
TYMLOS Phase 2 Histomorphometry study results
Oral Presentation #1040; Saturday, September 12, 11:00AM
- Heterogenicity in the Cortical Response to Abaloparatide and Teriparatide in the Proximal Femur by DXA-Based 3D Modeling (Winzenrieth)
P-463; Friday, September 11, 10AM-4PM
- Abaloparatide is more effective than PTH in restoring bone formation and bone structural properties, but both agents similarly correct the impaired bone material properties and citrate content in mice with Type 1 Diabetes (Ozgurel)
P-053; Friday, September 11, 10AM-4PM
- Abaloparatide Improves Bone Mass and Microarchitecture Without Increasing Resorption in Adult Rats Subjected to Hindlimb Unloading (Teguh)
P-707; Friday, September 11, 10AM-4PM
- Abaloparatide Promotes Bone Repair of Vertebral Defects in an Ovariectomized Rat Model of Osteoporosis (Makino)
P-607; Friday, September 11, 10AM-4PM
About Postmenopausal Osteoporosis
Osteoporosis is a silent disease, often displaying no signs or symptoms until a fracture occurs. 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 occur in women. Individuals who had a fracture are at increased risk for refracture yet many remain unevaluated and untreated.
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 or breast cancer.
About TYMLOS (abaloparatide) injection
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 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.
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
Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine therapeutics. 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 the incidence of osteoporotic fractures and the health burden associated with osteoporosis and the potential clinical uses and therapeutic and other benefits of our product candidates, including abaloparatide-patch.
These forward-looking statements are based on management's current expectations. These statements involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: the adverse impact the COVID-19 pandemic may have on our business; availability of additional capital; uncertainty regarding the results of regulatory submissions and oversight; success of our commercial operations; success of our clinical trials and preclinical studies; risks related to manufacturing, supply and distribution; the risk of litigation or other challenges regarding our intellectual property rights; success of any collaboration or partnership agreements. 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, 2019 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. 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.
Investor Relations & External Communications Contact:
Elhan Webb, CFA