Radius Intelligence, Inc.

Lower levels of oestrogen during menopause increases the risk of developing osteoporosis. Credit: Miss Ty via Shutterstock. Theramex’s Eladynos (abaloparatide) will be available for menopausal women with osteoporosis in England within three months, following positive guidance from The National Institute for Health and Care Excellence (NICE). The drug, which is marketed by Radius Health as Tymlos in the US, increases bone density by stimulating the cells that make new bone and this reduces the risk of fracture. It is an injection that comes as a pre-filled pen that people can self-administer at home once a day. Women’s health company Thermax acquired Eladynos through a March 2023 exclusive licensing agreement with Radius. Under the terms of the deal, Theramex can commercialise Eladynos in the European Economic Area, the UK, Australia, and Brazil. In April 2017, the injection was approved by the US Food and Drug Administration (FDA) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, and in December 2022 for the treatment of men with osteoporosis at high risk for fracture. Menopause can accelerate bone loss and increase the risk of osteoporosis due to the decline in oestrogen levels, which are crucial for maintaining bone density. The usual treatment for osteoporosis after menopause in people with a very high risk of fracture includes UCB and Amgen ’s Evenity (romosozumab) or Eli Lilly’s Forsteo (teriparatide). See Also: Eli Lilly boosts sales forecast by $3bn as diabetes and weight loss drugs propel revenue Recursion and Exscientia merge to form drug discovery company Monoclonal antibody Evenity works by inhibiting sclerostin to increase bone formation and simultaneously reducing bone resorption. It was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in 2020. In April 2022, NICE reversed its previous decision from November 2021 and recommended Evenity, after its earlier concerns about cost were addressed. The drug pulled in $1.16m in 2023, as per Amgen’s financials. Despite the recommendation for Evenity, some patients cannot tolerate it due to side effects such as osteonecrosis, and they stop taking the drug. Forsteo works in a similar but not identical manner to Eladynos by acting as a synthetic form of parathyroid hormone (PTH), stimulating bone formation by activating osteoblasts. Eladynos, a synthetic peptide that is a PTH-related peptide analogue, offers a different binding profile and may provide greater efficacy according to some studies. NICE has said that Eladynos could benefit more than 14,000 people in England. According to GlobalData, the osteoporosis market is forecast to generate $17.9bn across the seven major markets (US, UK, France, Germany, Spain, Italy, and Japan) by 2033. GlobalData is the parent company of Pharmaceutical Technology. In the announcement accompanying the recommendation, NICE’s chief medical officer Jonathan Benger said: “Our focus is on enabling access to care that improves quality of life while offering value to the taxpayer. Abaloparatide has been found by our independent committee to be clinically and cost-effective at reducing the risk of fracture, giving people more independence and therefore a better quality of life.”

GlobalData predicts osteoporosis sales across seven major markets will hit $17.9 billion in 2033. Change is coming to the osteoporosis market. GlobalData analysts have tipped the market to shift from bisphosphonates to anabolics, putting Amgen and its rivals in line to capture the additional $7 billion in annual sales that are forecast by 2033. Bisphosphonates treat osteoporosis by slowing the rate that bone is broken down, thereby maintaining bone density. Anabolic drugs promote new bone formation by activating osteoblasts. Bisphosphonates are the go-to treatment option, with the American College of Physicians recommending them as first-line therapy in most patients, but GlobalData analyst Sulayman Patel expects anabolics to gain ground. “Despite their higher cost over traditional bisphosphonates, [anabolics’] effectiveness in enhancing bone density justifies their increasing adoption,” Patel said. “This shift reflects a broader trend in healthcare towards prioritizing outcomes over initial costs. However, balancing affordability and accessibility with clinical efficacy remains a challenge that pharmaceutical companies must continue to navigate.” GlobalData predicts osteoporosis sales across the U.S., France, Germany, Italy, Spain, the U.K. and Japan will hit $17.9 billion in 2033, up from $10.5 billion last year. The analysts expect anabolics, including Eli Lilly’s Forteo and Amgen’s Evenity, to gain market share. Forteo lost its blockbuster status in 2021 and fell off the list of Lilly’s bestselling products altogether in 2023. Evenity rose as Forteo fell, with sales of the newer drug climbing 47% to almost $1.2 billion in 2023. Radius Health sells another anabolic osteoporosis drug, Tymlos. Sales of the medicine hit $219 million in 2021. Two investment groups took Radius private the following year. Generic drug makers are targeting the market. Teva launched a generic copy of Lilly’s Forteo in the U.S. in November. Ambio and Apotex won FDA approval for their generic version of Forteo weeks later. The U.S. patents covering Evenity are scheduled to expire between 2026 and 2033.

BOSTON, MA / ACCESSWIRE / June 25, 2024 / Radius Pharmaceuticals, Inc., a wholly owned subsidiary of Radius Health, Inc. ("Radius" or the "Company"), a specialty biopharmaceutical company focused on bone health and related areas, announced the appointment of Renata Sklodowska, M.D. as Senior Vice President, Medical Operations. Dr. Sklodowska joins Radius with over fifteen years of clinical development, regulatory, and medical affairs experience. She will report to Scott Briggs, Chief Executive Officer, and will oversee Medical Operations including Medical Affairs, Regulatory Affairs, and Pharmacovigilance (PV). "I am very pleased to welcome Renata to our Executive Leadership Team at Radius," said Scott. "Renata's extensive pharmaceutical industry experience, as well as her strong leadership track record in global medical and scientific affairs, will be extremely valuable as Radius continues to build its presence in bone health and related areas. Of particular importance will be Renata's strong patient-focus and ability to build alliances with medical, scientific, and patient communities to support our efforts with TYMLOS® and BINOSTO®." Dr. Sklodowska is an accomplished international pharmaceutical and biotech executive with Medical and Scientific Affairs expertise,as well as commercial experience. Her tenure includes more than fifteen years in the rare diseases area, including Endocrinology, with proven success preparing and supporting successful product launches as well as managing product portfolios. Dr. Sklodowska has an established history leading Medical Affairs activities for development stage and marketed drugs and a tested ability to create, train, and lead cross-functional teams to attain business objectives. Dr. Sklodowska has established global PV systems and provided oversight for the PV, drug safety, and risk management activities for numerous marketed products. As part of her responsibilities, she will also provide important scientific and medical expertise and guidance to support therapeutic area and product assessments behind business development efforts at Radius. "I look forward to joining the Radius team and applying my years of experience to build upon the company's successes to date, and to not only support TYMLOS® and BINOSTO®, but to also provide medical and strategic insight to explore opportunities to expand the Radius portfolio over time," stated Dr. Sklodowska. Prior to joining Radius, Dr. Sklodowska held several leadership positions in clinical development and medical affairs at biotech and global pharmaceutical companies, having most recently served as Vice President of Medical Affairs at F2G and Recordati Rare Diseases. Dr. Sklodowska received her Doctor of Medicine degree from the Medical University of Bialystok, Poland where she was also an attending physician. 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. 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