Theramex launches Bijuva® / Bijuve® (estradiol and progesterone), the first and only body-identical combined hormone therapy treatment for post-menopausal women*

Rhea-AI Summary

Theramex has launched Bijuva® / Bijuve® (1mg estradiol / 100mg progesterone) in Europe and the UK. This body-identical hormone therapy is the first of its kind for post-menopausal women with intact uterus, aimed at alleviating symptoms of estrogen deficiency. Unlike synthetic hormones, Bijuva® and Bijuve® are chemically identical to natural hormones, associated with lower health risks. Clinical trials show significant improvements in vasomotor symptoms and quality of life during treatment, making it a vital option for women seeking effective HRT.

Positive

• Launch of Bijuva® / Bijuve® represents a unique body-identical HRT for post-menopausal women.
• Clinical trials demonstrated statistically significant improvement in vasomotor symptoms such as hot flushes.
• Lower associated health risks compared to synthetic hormone alternatives.
• Approval aligns with increasing demands for safer menopause treatment options.

Negative

• None.

LONDON--(BUSINESS WIRE)-- PRESCRIBING INFORMATION IS AVAILABLE AT THE END OF THIS RELEASE

FOR MEDICAL BUSINESS / HEALTHCARE INDUSTRY TRADE MEDIA ONLY

Theramex has today launched Bijuva^® / Bijuve^® (1mg estradiol / 100mg progesterone) across Europe and the UK. Bijuva^®, (known as Bijuve^® in the UK), is the first, and only, body-identical hormone therapy treatment (HRT) for estrogen deficiency symptoms in post-menopausal women with intact uterus and at least 12 months since last menses, which combines estradiol and progesterone in a single daily oral capsule.^1,2 Unlike synthetic hormone products, the estradiol and progesterone found in Bijuva^® / Bijuve^® are chemically and biologically identical to the hormones naturally circulating in the woman’s body.³

Real-world evidence, recognised by NICE and the British Menopause Society, suggests that use of body‑identical hormones is associated with lower risks compared to synthetic versions. ^4,5 In particular, the evidence base demonstrates that body-identical hormones have not been shown to increase the risk of venous thromboembolism and are safer forms of HRT with respect to the risk for breast cancer, heart disease, heart attack, and stroke.^6-8

The idea of using body identical hormones to replace estrogens and to protect the endometrium with progesterone appeals to many women⁹. These hormones that many women prefer are now available in a combined single capsule that has been shown to be effective and well-tolerated.^1,9

Dr Paula Briggs, incoming Chair of the British Menopause Society, said, “We know women can be concerned about taking hormones and the impact they may have on their health beyond treating menopause symptoms. The availability of a body-identical progesterone which is well tolerated and has a lower risk profile than oral synthetic progestogens, combined with estradiol in a single capsule, is great news for women. As a healthcare community we should encourage our patients to reconsider the benefits of newer therapeutic options, allowing them to make informed choices.”

Theramex CEO, Robert Stewart, commented, “For many years menopausal women and their healthcare providers have been seeking an EMA approved body-identical combination therapy. The approval of Bijuva^® / Bijuve^® during Menopause Awareness month represents an important new opportunity for menopausal women suffering from moderate to severe vasomotor symptoms.”

ENDS

Notes to Editor

About Bijuva^® / Bijuve^®

Bijuva^® / Bijuve^® is a fixed dose, oral, continuous combined hormonal replacement therapy (HRT) capsule containing 1mg estradiol and 100mg micronised progesterone.¹ Known as Bijuve^® in the UK, it is the first approved oral continuous combined body-identical estradiol–progesterone formulation in a single capsule.² It is indicated for continuous combined HRT for estrogen deficiency symptoms in postmenopausal women with intact uterus and with at least 12 months since last menses.¹ In a robust, long-term, phase III clinical trial, Bijuva^® / Bijuve^® demonstrated clinically relevant and statistically significant improvement in the reduction of frequency and severity of moderate-to-severe vasomotor symptoms (VMS) such as hot flushes and night sweats as early as week 3 vs placebo.⁹ It also demonstrated significant improvement in sleep without causing drowsiness, which delivered a significant improvement in quality of life for women taking part in the study.⁹ Importantly Bijuva^® / Bijuve^® safety was studied over 12 months of treatment, and demonstrated endometrial protection, as well as no significant changes in lipid, coagulation or glucose parameters as compared to placebo.⁹

The most common adverse reactions (≥3 percent) were breast tenderness, headache, vaginal bleeding, vaginal discharge and vaginal hemorrhage.⁹ Theramex has a license and supply agreement with TherapeuticsMD (Nasdaq: TXMD) to commercialize BIJUVA outside the United States, Canada and Israel.¹⁰

The burden of menopause

During menopause, patients may experience undesirable symptoms including vasomotor symptoms (VMS) such as hot flushes and night sweats. ^11-15 In addition, women may also experience sleep deprivation, headaches, inability to concentrate, loss of memory, mood swings, vaginal dryness, loss of libido and stiffness of joints and muscles, all of which can deteriorate their quality of life. ^11-15 It is estimated that vasomotor symptoms are experienced by around 75% of menopausal women and for around a third of these women, symptoms are severe.⁵ Up to three-quarters of post-menopausal women experience sleep disorders, which negatively impact health-related quality of life (HRQoL) and work productivity.^16,17 Menopausal symptoms can typically last around 4 years, and in around 10% of women can last up to 12 years post-menopause.⁴ Direct and indirect costs associated with caring for women with VMS are significantly higher than for women without VMS.^16,18

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.

References

* With intact uterus and at least 12 months since last menses

1 Theramex 2021, Summary of Product Characteristics

² FDA Summary Review. 2018. Available at https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210132Orig1s000SumR.pdf. Accessed September 2021.

³ Kuhl H. 2005;8(Suppl 1):3-63.

⁴ National Institute for Health and Care Excellence. Available at https://www.nice.org.uk/guidance/ng23/. Accessed September 2021.

⁵ British Menopause Society. Available at https://thebms.org.uk/publications/consensus- statements/hormone-replacement-therapy/. Accessed September 2021.

⁶ Holtorf K. Postgrad Med. 2009;121(1):73–85.

⁷ Mirkin S. Climateric. 2018;21(4):346-354.

⁸ Fournier A, Berrine F, Clavel-Chapelon F. Breast Cancer Res Treat. 2008;107:103-111.

⁹ Archer DF, Bernick BA, Mirkin S. Expert Rev Clin Pharmacol. 2019;12(8):729–39.

¹⁰ Theramex. (7^th June 2019). https://www.sec.gov/Archives/edgar/data/25743/000138713119004260/ex99-1.htm

¹¹ Davis SR et al. Nat Rev Dis Primers. 2015;1: 15054. Menopause. Nat Rev 2015;1:1-19

¹² Greendale GA et al. JAMA. 2020;323(15):1495-6.

¹³ Joffe Het al. Clin Endocrinol Metab. 2016; 101(10): 3847-55.

¹⁴ Zervas IM et al. Menopause. 2009;16(4): 837-42.

¹⁵ Jehan S et al. J Sleep Disord Ther. 2015;4(5):1-18.

¹⁶ DiBonaventura MD et al. Int J Womens Health. 2013;5:261–9.

¹⁷ Baker FC et al. Sleep Med Clin. 2018;13(3):443–56.

¹⁸ Sarrel P et al. Menopause. 2015;22(3):260–6.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210921005635/en/

Andrew Bradley, Head of Communications Theramex

andrew.bradley@theramex.com / +44 (0)7864 167 962

Claire Paling, Makara Health

helenrae@makarahealth.com / +44(0)7594 225 273

Source: Theramex

FAQ

What is Bijuva® / Bijuve® and its indication?

Bijuva® / Bijuve® is a combined hormonal replacement therapy indicated for post-menopausal women with intact uterus, aimed at alleviating estrogen deficiency symptoms.

What are the primary components of Bijuva®?

Bijuva® contains 1mg of estradiol and 100mg of micronised progesterone, both of which are body-identical hormones.

What clinical benefits does Bijuva® offer?

Clinical trials showed significant improvements in reducing the frequency and severity of moderate-to-severe vasomotor symptoms, enhancing quality of life.

What are the safety aspects of Bijuva® compared to synthetic hormones?

Bijuva® is associated with lower health risks, including no increased risk of venous thromboembolism and lower risks for breast cancer and heart disease.

Who commercializes Bijuva® outside the US?

Theramex has a license and supply agreement with TherapeuticsMD (NASDAQ: TXMD) to commercialize Bijuva® outside the United States, Canada, and Israel.