Hyperparathyroidism, Primary

TYMLOS®demonstrated a lower incidence of hip fracture and non-vertebral fracture compared to teriparatide in women with osteoporosis 50 years and older (n=43,352) in this analysis of real-world data BOSTON, MA / ACCESSWIRE / April 16, 2024 / Radius Pharmaceuticals, Inc., a wholly owned subsidiary of Radius Health, Inc. ("Radius" or the "Company"), a specialty biopharmaceutical company focused on bone health, presented real-world evidence from an analysis comparing the effectiveness of TYMLOS® (ABL) to teriparatide (TPTD) in women with osteoporosis ages 50 years and older who were new to anabolic therapy (n=43,352). In this analysis of over 18-months of treatment, abaloparatide demonstrated a lower incidence of hip fracture and non-vertebral fracture compared to teriparatide. Hip fractures were reported in 1.1% of women in the ABL cohort and 1.4% of women in the TPTD cohort (HR [95% CI] 0.83 [0.70, 0.98]; P=0.03). Nonvertebral fractures were reported in 4.4% of women in the ABL cohort and 5.0% of women in the TPTD cohort (0.88 [0.80, 0.96]; P=0.003). Major cardiovascular events were balanced between cohorts.1 "The real-world data presented further supports the favorable efficacy and safety pro TYMLOS and why it is an important treatment option in the management of osteoporosis," said Dr. Felicia Cosman, Professor of Medicine at Columbia University College of Physicians and Surgeons in New York, NY, an osteoporosis specialist and clinical scientist and Co-Editor in Chief of the Journal Osteoporosis International. "Harnessing real-world evidence from everyday clinical settings affords clinicians the opportunity to uncover insights that can help guide treatment decisions." The data was presented in an abstract and oral presentation at the 24th Edition of the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO) in London, on April 12th, 2024. This real-world retrospective observational cohort study identified women 50 years and older, newly initiated on anabolic therapy with ABL or TPTD between May 1, 2017, and Dec 31, 2021.This analysis included pre-specified outcomes and utilized propensity score matching to help balance the characteristics in each treatment group; patients were well matched on 73 baseline parameters.1 Patients were identified using anonymized claims data from the Symphony Health Patient Source, Osteoporosis Patient Transactional Datasets. This is a disease specific subset of Integrated Dataverse® which includes data from over 307 million active patients. "We are very pleased to share the results of this analysis, as it further demonstrates the value of TYMLOS in the treatment of women with osteoporosis," said Scott Briggs, Chief Executive Officer of Radius. "Radius is committed to supporting men and postmenopausal women with osteoporosis, their families, and healthcare providers through our ongoing educational efforts as well as by generating data to support informed healthcare decision making." Real World Evidence: It is important to consider the limitations of RWE. RWE data sources may have incomplete information, leading to challenges in identifying and characterizing specific populations accurately. The source and type of RWE may limit the generalizability of the endpoints to broader populations/settings. RWE should be used in supplement to clinical trial evidence to support healthcare decision making. Due to data limitations, mortality data was not available in this dataset. There are no head-to-head randomized controlled clinical trials comparing abaloparatide and teriparatide. INDICATONS and IMPORTANT SAFETY INFORMATION INDICATIONS TYMLOS is indicated for: the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or 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, and the treatment to increase bone density in men withosteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy. IMPORTANT SAFETY INFORMATION2 Contraindications: TYMLOSis contraindicated in patients with a history of systemic hypersensitivity to abaloparatide or to any component of the product formulation. Reactions have included anaphylaxis, dyspnea, and urticaria. Risk of Osteosarcoma: It is unknown whether TYMLOS will cause osteosarcoma in humans. Osteosarcoma has been reported in patients treated with a PTH-analog in the post marketing setting; however, an increased risk of osteosarcoma has not been observed in observational studies in humans. There are limited data assessing the risk of osteosarcoma beyond 2 years of TYMLOS use. Avoid use of TYMLOS for patients at an increased baseline risk for osteosarcoma including patients with open epiphysis (pediatric and young adult patients); metabolic bone diseases other than osteoporosis, including Paget's disease of the bone; bone metastases or a history of skeletal malignancies; prior external beam or implant radiation therapy involving the skeleton; or hereditary disorders predisposing to 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: TYMLOSmay 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: TYMLOSmay 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. Pregnancy and Lactation: TYMLOSis not indicated for use in females of reproductive potential. Adverse Reactions: The most common adverse reactions (incidence ≥2%) reported with TYMLOS in postmenopausal women with osteoporosis are hypercalciuria (11%), dizziness (10%), nausea (8%), headache (8%), palpitations (5%), fatigue (3%), upper abdominal pain (3%), and vertigo (2%). The most common adverse reactions (incidence ≥2%) reported with TYMLOS in men with osteoporosis are injection site erythema (13%), dizziness (9%), arthralgia (7%), injection site swelling (7%), injection site pain (6%), contusion (3%), abdominal distention (3%), diarrhea (3%), nausea (3%), abdominal pain (2%), and bone pain (2%). Please see full Prescribing Information. About Abaloparatide2 Abaloparatide (TYMLOS®) 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 a history of osteoporotic fracture or 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. In December 2022, Abaloparatide (TYMLOS®) was approved for the treatment to increase bone density in men with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy. Abaloparatide is supplied as a single-patient multi-use prefilled pen designed to subcutaneously administer 80 micrograms per dose over a 30-day period. About Radius: Radius is a global biopharmaceutical company focused on addressing unmet medical needs in the areas of bone health and related areas. Radius' lead product, TYMLOS® (abaloparatide) injection, was approved by the U.S. Food and Drug Administration in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture, and in December 2022 to increase bone density in men with osteoporosis at high risk for fracture. Radius also recently announced an exclusive licensing and distribution agreement for the U.S. rights to BINOSTO® (alendronate sodium) effervescent tablet for oral solution, expanding the Company's presence in bone health. Reginster JY, et al. The comparative effectiveness and cardiovascular safety of abaloparatide and teriparatide in postmenopausal women new to anabolic therapy: update of a real-world retrospective analysis. Presented at the WCO-IOF-ESCEO Annual Meeting, April 11-14, 2024 in London, UK. Accessed April 10, 2024. TYMLOS® [prescribing information]. Boston, MA: Radius Health, Inc. TYMLOS® Medication Guide. Radius Health, Inc.; Boston, MA. Contact: Sara Goldberg: Head of Communications Email: corporatecommunications@radiuspharm.com Phone: +1 (631) 379-8374 SOURCE: Radius Health, Inc. View the original press release on accesswire.com

AstraZeneca is splashing out $800 million upfront to bolster its rare disease pipeline with the purchase of Amolyt Pharma and its Phase III asset for chronic hypoparathyroidism.Marc Dunoyer, chief executive of AstraZeneca’s rare-disease unit Alexion, noted that patients with chronic hypoparathyroidism “face a significant need for an alternative to current supportive therapies,” with Amolyt’s eneboparatide holding “the potential to lessen the often debilitating impact of low parathyroid hormone and avoid the risks of high-dose calcium supplementation.”Eneboparatide – also known as AZP-3601 – is a PTH receptor 1 agonist that in Phase II studies has shown the ability to achieve normalisation of serum calcium levels, as well as the potential to eliminate dependence on daily calcium and vitamin D supplementation. AstraZeneca noted that in adults with chronic hypoparathyroidism and hypercalciuria, eneboparatide normalised calcium in urine, while it also preserved bone mineral density.According to Amolyt’s website, its pipeline also includes AZP-3813 for acromegaly - with initial Phase I results expected later this year - and the preclinical candidate AZP-40XX for primary hyperparathyroidism and humoral hypercalcemia of malignancy.Along with the upfront payment, Amolyt shareholders are eligible to receive an additional $250 million payable upon achievement of a specified regulatory milestone. The acquisition is expected to close by the end of the third quarter.

Pictured: AstraZeneca's headquarters in Silicon Valley/iStock, Sundry Photography AstraZeneca on Thursday announced that it is acquiring rare disease specialist Amolyt Pharma in a deal that could reach $1.05 billion in value. Under the terms of the agreement, AstraZeneca will buy Amolyt’s outstanding shares for a total of $800 million, due on the deal’s closing. Amolyt will also be entitled to a contingent payment of $250 million upon meeting a yet-undisclosed regulatory milestone. The partners expect to complete the transaction in the third quarter of 2024, pending regulatory clearances and other customary closing conditions. After the acquisition is closed, Amolyt and its employees will join AstraZeneca’s rare disease unit Alexion. At the center of the acquisition is Amolyt’s late-stage candidate for the rare disease hypoparathyroidism, which is characterized by low levels of the parathyroid hormones in the blood. Patients with hypoparathyroidism also have abnormal levels of calcium and phosphorous, which can lead to complications such as kidney problems and heart failure. “Chronic hypoparathyroid patients face a significant need for an alternative to current supportive therapies, which do not address the underlying hormone deficiency,” Alexion CEO Marc Dunoyer said in a statement, adding that eneboparatide could “lessen the often-debilitating impact of low parathyroid hormone” while also avoiding the “risks of high-dose calcium supplementation.” Dubbed eneboparatide, Amolyt’s candidate for hypoparathyroidism activates the parathyroid hormone receptor 1, leading to stable and sustained calcium levels in the blood and normal calcium excretion through the urine. According to the biotech’s website, this mechanism of action allows eneboparatide to treat the symptoms of hypoparathyroidism and avoid kidney disease, while also slowly removing the need for calcium and vitamin D supplementation. Eneboparatide also helps preserve bone integrity by normalizing bone turnover levels and lowering bone resorption. In a Phase IIa study, 93% of patients who were treated with eneboparatide were able to stop standard of care treatment using calcium and vitamin D supplementation. Urinary calcium excretion also dropped to normal levels, while serum calcium levels remained within target range. Patients also showed stable bone mineral density, including those who had osteopenia. In May 2023, Amolyt announced that it had competed an end-of-Phase II meeting with the FDA and that it would launch a Phase III study of eneboparatide in hypoparathyroidism. The biotech at the time envisioned the study, dubbed Calypso, to be the largest Phase III trial to date in this indication. Top-line data are expected by the end of 2024. In addition to eneboparatide, AstraZeneca will also gain ownership of AZP-3813, which is being assessed for acromegaly with topline Phase I data expected in the first half of this year. Amolyt is also developing AZP-40XX, which is still in the very early stages of development for primary hyperparathyroidism and humoral hypercalcemia of malignancy. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.