Theramex launches Livogiva®, a new teriparatide pre-filled pen for the treatment of severe osteoporosis

London, January 18 2021: Theramex has today launched Livogiva^® to patients in Europe for the first time. The treatment has been launched initially in Germany, with availability in other EU countries soon to follow – including France, Italy and Spain. Livogiva is a new presentation of teriparatide, the only bone anabolic treatment for osteoporosis, which has been developed as a pre-filled pen making it easy to use for patients at high risk of fractures.

Osteoporosis remains largely underdiagnosed and undertreated across Europe, resulting in a large number of fractures. Among the population aged over 50 years, one in three women and one in five men will suffer a fragility fracture.¹ Hip, spine and wrist fractures are the most common fractures, which have a debilitating impact on daily activities and quality of life.¹ 

“Improving women’s health is our key focus at Theramex and our commitment to supporting people with osteoporosis is an important part of this. The launch of Livogiva, a biosimilar, in the new pre-filled pen will expand patient choice and allow more women access to these important medicines. This new addition adds to our growing portfolio of medicines for all stages of osteoporosis from prevention with Calcium and Vitamin D to treatments which currently includes a next generation oral bisphosphonate which has flexible administration requirements for patients. We hope these medicines will make a real difference to the lives of women across Europe,” said Robert Stewart, CEO of Theramex.

Livogiva is a biosimilar of the reference medicine Forsteo^®, teriparatide, and therapeutic equivalence has been demonstrated in a Phase III clinical study in patients with severe osteoporosis who were treated for 6 months.² Teriparatide is made up of the active sequence of human parathyroid hormone. It stimulates bone formation by acting directly on osteoblasts.

“With osteoporosis still recognised as being hugely under treated, we welcome any new possibility that will expand the therapy options available to patients. As Livogiva can be administered by the patients themselves via the pre-filled pen, this has the potential to reduce the number of hospital and osteoporosis center visits as well as reducing the burden on nursing staff, saving precious hospital and general medical resources,” commented Dr Thomasius, Frankfurt Institute of Bone Health, Germany

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About Livogiva

Livogiva is indicated in the treatment of osteoporosis in postmenopausal women at increased risk of fracture.² The pivotal study included 1,637 postmenopausal women (mean age 69.5 years).² At baseline, ninety percent of the patients had one or more vertebral

fractures and, on average, vertebral BMD was 0.82 g/cm² (equivalent to a T-score = - 2.6).² All patients were offered 1,000 mg calcium per day and at least 400 IU vitamin D per day.² After 19 months (median) treatment, bone mineral density (BMD) had increased in the lumbar spine and total hip, respectively, by 9% and 4% compared with placebo (p < 0.001).² The most commonly reported adverse reactions in patients treated with Livogiva are nausea, pain in limb, headache and dizziness.² Livogiva can be prescribed as a first-line treatment at the time of diagnosis, in the absence of any contraindication.² Its administration is by daily subcutaneous injection.²

About Theramex

Theramex is a leading, global speciality pharmaceutical company dedicated to women and their health. With a broad portfolio of innovative and established brands covering contraception, fertility, menopause and osteoporosis, we support women at every stage of their lives. Our commitment is to listen and understand our patients, serve their needs and offer healthcare solutions to help improve their lives. Our vision is to be a lifetime partner for women and the healthcare professionals who treat them, by providing innovative and effective solutions that care for and support women as they advance through each stage of their lives.

For further information please contact:                                       

Anjuna Kalsi

Anjuna.Kalsi@theramex.com

T: +44 (0) 7875 760235

References:

1. IOF Compendium of Osteoporosis. 25^th September 2019. osteoporosis.foundation/sites/iofbonehealth/files/2020-01/IOF-Compendium-of-Osteoporosis-web-V02.pdf Last accessed 6 January 2021.
2. Livogiva SPC https://ec.europa.eu/health/documents/community-register/2020/20200827148839/anx_148839_en.pdf Last accessed 6 January 2021.