Osteitis Deformans

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

FRIDAY, Jan. 12, 2024 -- For patients undergoing surveillance following diagnosis and treatment of ductal carcinoma in situ (DCIS), very few second breast cancers are detected by clinical breast examination by a physician, according to a study published online Dec. 28 in the Journal of the National Comprehensive Cancer Network . Bethany T. Waites, M.D., from the Kaiser Permanente San Francisco Medical Center, and colleagues performed a retrospective cohort study of patients with DCIS treated between Jan. 1, 2008, and Dec. 31, 2011, to assess the modes of detection of second cancers. The study cohort included 1,550 women (median age at diagnosis, 59 years), who were followed for a median of 10 years. During follow-up, 179 women (11.5 percent) were diagnosed with a second breast cancer: 43.0, 54.8, and 2.2 percent were ipsilateral, contralateral, and presented with distant metastases, respectively. Of the second cancers, 61.5, 36.3, and 2.2 percent were invasive, DCIS, and Paget disease, respectively. The researchers found that second breast cancers were imaging-detected, patient-detected, physician-detected, and detected incidentally on imaging or pathology from procedures unrelated to oncologic care in 74.3, 20.1, 2.2, and 3.4 percent of cases, respectively. "Our findings highlight the importance of mammogram screening and patient education regarding self-detection, and can inform future National Comprehensive Cancer Network recommendations for DCIS survivorship care," the authors write. Abstract/Full Text Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions. Posted January 2024 More news resources FDA Medwatch Drug Alerts Daily MedNews News for Health Professionals New Drug Approvals New Drug Applications Drug Shortages Clinical Trial Results Generic Drug Approvals Subscribe to our newsletter Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Forteo® (teriparatide injection) is indicated to treat osteoporosis among certain women and men. This approval showcases Teva’s proven strengths in complex generic formulations development and device engineering. The approval and subsequent launch will enhance access to a critical treatment option for patients while serving to demonstrate Teva’s strategic goal of sustaining a generic powerhouse. PARSIPPANY, N.J. & TEL AVIV, Israel--(BUSINESS WIRE)-- Teva Pharmaceuticals Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today the approval of a generic version of Forteo®1, in the United States. Market availability of the product in the U.S. is expected in the coming weeks. Teriparatide injection is indicated to treat osteoporosis among certain women and men. Please see the below “What is?” section for more information. “We are thrilled to receive the long-awaited generic approval of this important drug-device combination product,” said Dr. Eric Hughes, Executive Vice President Global R&D and Chief Medical Officer. “This approval showcases Teva’s exceptional strengths in complex generic formulations development and device engineering, which support our ambitions to focus our generics pipeline on medicines that deliver the highest impact to patients. The approval will enhance access to a critical treatment option for patients while serving to demonstrate our strategic goal of sustaining a generic powerhouse.” With nearly 500 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market and holds the leading position in first-to- with approximately 100 pending first-to-files in the U.S. Currently, 1 in 12 generic prescriptions dispensed in the U.S. is filled with a Teva generic product. Forteo® had annual sales of $609 million as of July 2023, according to IQVIA data. Teva’s generic equivalent of Forteo® (teriparatide injection) utilizes the Antares Pharma, Inc. multi-dose pen device. Antares, a wholly owned subsidiary of Halozyme Therapeutics, Inc., and Teva are parties to an exclusive license, development and supply agreement for Teriparatide auto injector product that Teva markets in the EU and will market in the U.S. What is teriparatide injection? Teriparatide injection is a prescription medicine used to: treat postmenopausal women who have osteoporosis who are at high risk for having broken bones (fractures) or who cannot use other osteoporosis treatments. Teriparatide injection can lessen the chance of broken bones (fractures) in the spine and other bones in postmenopausal women with osteoporosis. increase the bone mass in men with primary or hypogonadal osteoporosis who are at high risk for having broken bones (fractures) or who cannot use other osteoporosis treatments. treat both men and women with osteoporosis due to use of glucocorticoid medicines, such as prednisone, for several months, who are at high risk for having broken bones (fractures) or who cannot use other osteoporosis treatments. It is not known if Teriparatide injection is safe and effective in children. Teriparatide injection should not be used in children and young adults whose bones are still growing. IMPORTANT SAFETY INFORMATION What is the most important information I should know about teriparatide injection? Possible bone cancer. During drug testing, the medicine in Teriparatide injection caused some rats to develop a bone cancer called osteosarcoma. Studies in people have not shown that Teriparatide injection increases your chance of getting osteosarcoma. There is little information about the chance of getting osteosarcoma in patients using Teriparatide injection beyond 2 years. Who should not use Teriparatide injection? Do not use Teriparatide injection if you: are allergic to any of the ingredients in teriparatide injection. See the end of the Medication Guide for a complete list of the ingredients in Teriparatide injection. Symptoms of a serious allergic reaction of Teriparatide injection may include swelling of the face, lips, tongue or throat that may cause difficulty in breathing or swallowing. Call your healthcare provider right away or get emergency medical help if you get any of these symptoms. What should I tell my healthcare provider before using teriparatide injection? Before you use Teriparatide injection, tell your healthcare provider about all of your medical conditions, including if you: have a certain bone disease called Paget’s disease or other bone disease. have bone cancer or have had a history of bone cancer. are a young adult whose bones are still growing. have had radiation therapy. are affected with a condition that runs in your family that can increase your chance of getting cancer in your bones. have or have had too much calcium in your blood (hypercalcemia). have or have had a skin condition with painful sores or wounds caused by too much calcium. have or have had kidney stones. take medicines that contain digoxin. are pregnant or plan to become pregnant. It is not known if Teriparatide injection will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if Teriparatide passes into your breastmilk. You should not breastfeed while taking Teriparatide injection. Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. What are the possible side effects of Teriparatide injection? Teriparatide injection may cause serious side effects including: See “What is the most important information I should know about Teriparatide injection?” Bone cancer (osteosarcoma): Tell your healthcare provider right away if you have pain in your bones, pain in any areas of your body that does not go away, or any new or unusual lumps or swelling under your skin that is tender to touch. Increased calcium in your blood. Tell your healthcare provider if you have nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood. Worsening of your kidney stones. If you have or have had kidney stones your healthcare provider may check the calcium levels in your urine while you use Teriparatide injection to see if there is worsening of this condition. Decrease in blood pressure when you change positions. Some people may feel dizzy, get a fast heartbeat, or feel light-headed right after the first few doses of Teriparatide injection. This usually happens within 4 hours of taking Teriparatide injection and goes away within a few hours. For the first few doses, give your injections of Teriparatide injection in a place where you can sit or lie down right away if you get these symptoms. If your symptoms get worse or do not go away, contact your healthcare provider before you continue using Teriparatide injection. The most common side effects of Teriparatide injection include pain, nausea, and joint aches. These are not all the possible side effects of Teriparatide injection. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please read the Medication Guide in the full Prescribing Information. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and innovative medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of innovative and biopharmaceutical products. Learn more at . Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: the development, launch and commercial success of our generic version to Forteo® (Teriparatide injection); our ability to successfully compete in the marketplace, including that we are substantially dependent on our generic products, concentration of our customer base and commercial alliances among our customers, delays in launches of new generic products and the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; our ability to successfully launch and execute our new Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development and to sustain and focus our portfolio of generics medicines; our substantial indebtedness; our business and operations in general, including, the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto, and costs and delays resulting from the extensive pharmaceutical regulation to which we are subject; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the third quarter of 2023 and in our Annual Report on Form 10-K for the year ended December 31, 2022, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. 1 Forteo® is a registered trademark of Eli Lilly Pharmaceuticals.