Theramex HQ UK Ltd.

The UK's National Institute for Health and Care Excellence (NICE) recommended Theramex’s Yselty (linzagolix) as a treatment option for moderate-to-severe symptoms of uterine fibroids in adult women of reproductive age. Subsequent to the decision, the oral gonadotropin-releasing hormone (GnRH) receptor antagonist can now be routinely prescribed to eligible patients through the NHS in England and Wales.Backed by the two Phase III PRIMROSE trials, Yselty was approved in the EU and UK in 2022, making it the first GnRH antagonist offering a non-hormonal option for women with uterine fibroids. “Linzagolix offers greater flexibility as it can be taken either with or without hormone therapy and means clinicians can provide more personalised care,” said Jonathan Benger, NICE chief medical officer. Longer-term use onlyNICE noted that the drug is only recommended for longer-term use of over 6 months and is unsuitable for those requiring short-term treatment, such as before uterine fibroid surgery. Yselty carries an annual list price of £1097.20 ($1410) and £1040.00 ($1336) with and without hormonal add-back therapy, respectively.According to NICE, around a third of women are likely to develop symptomatic uterine fibroids during their lifetime and up to 30,000 women in England and Wales could benefit from the new treatment option. “We are continuing to work with NICE and the NHS in the hope that we can provide as many women as possible the opportunity to access this treatment, wherever they live,” remarked Tina Backhouse, UK general manager at Theramex.Originally an asset of Kissei Pharmaceutical, the GnRH antagonist was licensed to ObsEva in 2015 for commercialisation outside Asia. In 2022, ObsEva struck a deal with Theramex to support the drug’s commercialisation in markets excluding the US, Canada and Asia. However, ObsEva soon ran into trouble with the FDA regarding the drug’s US filing, resulting in a strategic restructuring and Theramex being assigned as Kissei’s ex-Asia licensing partner.

The National Institute for Health Care and Research has recommended Theramex’s Eladynos (abaloparatide) as an option for treating bone disease after menopause. Available on the NHS in England in three months, the drug is set to benefit more than 14,000 people in the UK who are seeking treatment for osteoporosis after menopause, if there is a very high risk of fracture. Osteoporosis, a bone disease that affects 3.8 million people in the UK, develops when bone mineral density and bone mass decrease, or when the quality or structure of bone changes, leading to a decrease in bone strength that can increase the risk of broken bones or fractures. The disease particularly affects older women after menopause, as oestrogen, the hormone important for maintaining bone density and strength, decreases and bone density reduces, making broken bones more common. Other treatments for the disease include bisphosphonates such as alendronic acid and ibandronic acid, Eli Lilly’s selective oestrogen receptor modulator, Evista (raloxifene), parathyroid hormone treatments including teriparatide, and biological medicines including Amgen’s Prolia (denosumab) and Amgen/UCB’s Evenity (romosozumab). NICE’s decision was based on patients descriptions of how debilitating osteoporosis can be and how it all impacts day-to-day life, impairing mental and physical health. Theramex’s Eladynos is designed to increase bone density by stimulating the cells that produce new bone while also reducing the risk of fracture, providing an alternative for patients who have not responded to or cannot tolerate usual treatment options. Proven to be more clinically and cost-effective, the alternative treatment option comes as a pre-filled pen that is injected into the muscle through the skin. Prior to this, in March, Bayer shared positive long-term results from the late-stage OASIS 3 study, which supported the use of its investigational non-hormonal menopause drug, elinzanetant, to treat moderate-to-severe vasomotor symptoms (VMS), such as hot flashes, which are reported by up to 80% of women during the menopausal transition. In April, a Canadian study published in Neurology revealed that early menopause and a higher risk of cardiovascular disease could be linked to cognitive decline later in life.

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.”