Business Wire

THERAMEX

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

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. (7th 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.

Link:

ClickThru

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

CapVest and Parquest Agree Terms on IPN’s Acquisition of Sopral8.7.2025 10:00:00 CEST | Press release

Inspired Pet Nutrition (“IPN”), the fast-growing pet food company controlled by CapVest Partners LLP (“CapVest”), and Parquest, a leading investment firm, have agreed terms on the acquisition of Sopral, a prominent branded pet food platform serving the European market, with manufacturing operations based in France. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250708134461/en/ Sopral products The transaction is subject to customary regulatory approvals and closing conditions. Financial terms have not been disclosed. Based in Pléchâtel, Brittany, France, Sopral is a leading manufacturer of branded premium dry petfood with a comprehensive range of high-quality nutritional solutions, including Pro-Nutrition Prestige, Pure Life and Protect brands. Sopral has a strong footprint and reputation in France and a fast growing online and international market presence in over 50 countries around the world. Employing over 130 people, th

Thales Reinforces its Leadership in eSIM and IoT Connectivity with a ‘Ready to Use’ Certified Solution8.7.2025 08:00:00 CEST | Press release

At a time when billions of connected objects are reshaping industries, Thales has achieved an essential security certification for its eSIM solution, reinforcing its leadership in trusted connectivity management for the Internet of Things (IoT). The certification, granted by the GSMA under the eSIM Security Assurance (eSA) scheme, marks a significant milestone in enabling large-scale, secure, and efficient IoT deployments across industries including smart metering, healthcare, and automotive. This positions Thales as a trusted partner capable of providing full protection against advanced cyber threats — delivering end-to-end security solutions, from chip to cloud, and ensuring compliance with emerging security standards (e.g., the EU Cyber Resilience Act). With over 5.8 billion IoT cellular connections expected globally by 2030 (GSMA Intelligence), businesses and industries face growing pressure to deploy connected devices at scale — securely and efficiently. The SGP.32 IoT specificati

Invivoscribe Expands Flow Cytometry Services to Accelerate CAR-T Immunotherapy Development and Regulatory Readiness with the Initiation of CERo Therapeutics Phase 1 Clinical Trial8.7.2025 06:00:00 CEST | Press release

Invivoscribe Inc., a global leader in precision diagnostics and measurable residual disease (MRD) testing, is proud to support CERo Therapeutics Holdings, Inc., an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms. Through this collaboration, LabPMM (Invivoscribe’s global reference laboratories) have customized their multiparametric flow cytometry (MFC) services and implemented their sensitive MFC AML MRD assay to supportCERo’s clinical trial of its lead compound, CER-1236. The trial targets Acute Myeloid Leukemia (AML) in patients who are relapsed/refractory, in remission with MRD, or newly diagnosed with TP53-mutated MDS/AML. AML is an aggressive blood cancer characterized by the rapid accumulation of abnormal myeloid cells in the bone marrow and blood, disrupting normal hematopoiesis.1 Treating AML is especially complex due to its genetic heterogeneity and the high risk of relapse. CAR-T (chime

Tigo Energy Adds Solar-Plus-Storage Portfolio in Czech Republic to Build on MLPE Success8.7.2025 06:00:00 CEST | Press release

Successful PPDS P4 protocol certification opens full range of three-phase Tigo EI Inverters and the EI Residential product suite for grid connection in second-strongest E.U. market for Tigo. Tigo Energy, Inc. (NASDAQ: TYGO) (“Tigo” or “Company”), a leading provider of intelligent solar and energy software solutions, today announced that the Company’s entire portfolio of three-phase Tigo EI Inverters has successfully passed the certification tests for compliance with the PPDS P4 requirements in the Czech Republic. Compliance with PPDS P4, formally known as Distribution System Operation Rules, Annex 4, is a prerequisite for grid connection of solar inverters in the Czech Republic, validating the compatibility with the technical conditions defined by the European Commission and adopted by local utility companies. In the wake of the proliferation of rapid shutdown requirements across Europe, with installers in the Czech Republic deploying nearly 107MW of Tigo MLPE in 2024, Tigo products ha

Murata Launches World’s First High-Frequency Filter Using XBAR Technology for 5G, Wi-Fi 7, and Future 6G Networks8.7.2025 04:00:00 CEST | Press release

Murata Manufacturing Co., Ltd. (TOKYO: 6981) (ISIN: JP3914400001) has announced the mass production and commercial shipment of the world’s first*1 high-frequency filter using XBAR technology*2. Developed by combining Murata’s proprietary Surface Acoustic Wave (SAW) filter expertise with XBAR technology from Murata's subsidiary Resonant Inc., it enables the extraction of desired signals while achieving both low insertion loss and high attenuation. These features are critical for the latest wireless technologies, including 5G, Wi-Fi 6E, Wi-Fi 7, and emerging 6G technologies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250707682186/en/ [Murata Manufacturing Co., Ltd.] The world’s first high-frequency filter using XBAR technology The demand for reliable high-frequency communications continues to grow in response to the widespread deployment of 5G and the future development of 6G. Simultaneously, wireless local-area network (W

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye