Business Wire

THERAMEX

15.11.2021 11:02:05 CET | Business Wire | Press release

Share
Theramex Enters OTC Market with Femarelle®, a Non-hormonal Option to Treat Menopause Symptoms

Theramex, a company dedicated women’s health, recently acquired the Femarelle® product licence to treat menopause symptoms. Femarelle will be available in different markets from the 2nd quarter of 2022. This commercialisation agreement was reached with Se-cure Pharmaceuticals Ltd., the company that developed the product.

Femarelle® offers non-hormonal therapy to balance oestrogen levels in women from peri-menopause through menopause to post-menopause relieving the symptoms and conditions derived from oestrogen loss with the onset of menopause. It addresses specific needs at each menopause stage and is characterised by the natural compound DT56a, an oestrogen receptor modulator, supplemented with stage-appropriate vitamins and minerals. DT56a is developed from the soybean plant taking advantage of the 20 amino acids of soybean in its production process, resulting in a unique compound targeting the oestrogen receptors in the woman's body:

  • Femarelle® Rejuvenate, for women over 40 experiencing menstrual cycle fluctuations, the telltale sign of the onset of perimenopause. Femarelle Rejuvenate restores a woman's hormonal balance, supporting changing moods, loss of skin elasticity and fatigue.
  • Femarelle® Recharge, for women over 50 who may already be feeling classic menopause symptoms such as hot flushes and night sweats and which assists with additional aspects of menopause such as loss of libido.
  • Femarelle ®Unstoppable, for women over 60 who have gone through the bulk of their menopause and are now focused on maintaining bone and vaginal health as they age.

The DT56a compound adheres to oestrogen receptors without being recognised as oestrogen by the body. This unique non-hormonal botanical solution was declared a “first-line treatment for menopause management” at the Presidential Conference of the Annual Congress of the European Society of Gynaecology in 2017. Femarelle® is supported by gynaecologists around the world and has been published in leading journals.

In a survey of 4,000-plus women from different countries, hot flushes and night sweats were the main symptoms in all countries. Femarelle® was found to significantly relieve menopausal symptoms within the first two weeks of treatment and this trend continued following four weeks of treatment in all the countries surveyed. A statistically significant reduction was found at each week of treatment1 .

With this move, Theramex steps up its commitment to provide women with an effective and safe alternative to menopause hormone therapy. “Our main objective is to meet women’s health needs around the world,” said Theramex chief executive Robert Stewart . “Not only their current needs but future ones too in order to improve their lives. With Femarelle®, we are adding to our portfolio an alternative for women with untreated menopause who are reluctant to use hormone therapy”.

Esti Grunbaum , Vice President BD & Marketing at Se-cure Pharmaceuticals Ltd., said: “We are very excited about this collaboration with Theramex. Together we will provide women with more menopausal symptom treatment options”.

Jose Naranjo , Theramex Vice President Marketing, said: “We offer a non-hormonal option to healthcare professionals, backed by scientific studies verifying its safety and efficacy. This allows us to cover an unmet need for these women who will now be heard, understood and have access to a treatment that will provide them with greater adherence and therefore a better quality of life”.

About Theramex

Theramex is a leading global speciality pharmaceutical company dedicated to women and their health. We support women at every stage of their lives by providing a broad portfolio of innovative and established brands covering contraception, fertility, menopause and osteoporosis. Our commitment is to listen to 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 patient-focused and effective solutions that care for and support women through every stage of life.

About Se-cure Pharmaceuticals Ltd.

Se-cure Pharmaceuticals Ltd. is a research-driven biotech company focused on the discovery and development of therapeutic solutions originating from botanical sources with an emphasis on safety of use. Founded in 1997, Se-cure’s competencies include target-manipulated germination and proprietary agro-technologies used to engineer botanicals into tissue-targeted therapeutics.

Se-cure develops unique botanical therapies that integrate the pharmaceutical world with the supplement world, balancing them both to create highly effective therapies that can be taken for the long-term, improving quality of life without incurring risks. The API in our products are developed in-house, providing proprietary products with vast scientific support.

Se-cure has a state-of-the-art biotech-pharmaceutical manufacturing facility operating under rigorous quality control standards, producing standardised nutraceuticals with swift efficacy and the highest safety. We are dedicated to bringing forth unique botanical therapies that provide proven relief of symptoms while avoiding the risks of the conventional options

1 Genazzani A., Nachtigall L., Panay N. & Yoles I. Symposium: 2 Continents, 3 cultures, 4 countries, 2,000 women and Femarelle®; 13th World Congress on Menopause . Rome, Italy June 2011.
Sánchez-Borrego R., Mendoza N., Llaneza P. A prospective study of DT56a (Femarelle®) for the treatment of menopause symptoms; Climacteric . 2015;18(6):813-6.
Chen F.P et al. Efficacy of Femarelle for the treatment of climacteric syndrome in postmenopausal women: An open label trial. Taiwan J Obstet Gynecol . 2016;55(3):336-40.

THX_HQ_PRESSR_006034

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

Incyte Announces Positive CHMP Opinion for Opzelura® (ruxolitinib) Cream for the Treatment of Adults with Moderate Atopic Dermatitis26.6.2026 13:30:00 CEST | Press release

If approved, Opzelura® (ruxolitinib) cream will be the first steroid-free, topical JAK treatment option in the European Union (EU) for adults with moderate atopic dermatitis (AD) for whom standard topical therapies have failedAD, the most common type of eczema which affects 230 million people globally,1 is a chronic, recurring, inflammatory and highly pruritic (itchy) skin condition that can have a significant impact on daily life2Phase 3 TRuE‑AD4 data supporting the positive CHMP opinion demonstrated that ruxolitinib cream met both co‑primary endpoints at Week 8, maintained disease control with as-needed treatment through Week 24 and was well tolerated3,4,5 Incyte (Nasdaq: INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Opzelura® (ruxolitinib) cream for the treatment of moderate atopic dermatitis (AD) in adult patients for whom topical corticosteroids

Datroway® Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with Metastatic Triple Negative Breast Cancer Who Are Not Candidates for Immunotherapy26.6.2026 13:00:00 CEST | Press release

Recommendation based on TROPION-Breast02 phase 3 trial where Daiichi Sankyo and AstraZeneca’s Datroway showed a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival and progression-free survival If approved, Datroway has potential to be the first TROP2 directed antibody drug conjugate for patients in EU with a demonstrated overall survival benefit as first-line treatment Datroway® (datopotamab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use

DAYBU®(trofinetide) Recommended for Approval in the European Union by CHMP26.6.2026 12:49:00 CEST | Press release

-- European Commission decision expected in the coming months-- If approved, DAYBU®would become the first treatment for neurobehavioral symptoms of Rett syndrome in the European Union Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion following a re-examination procedure, recommending the granting of a marketing authorization for DAYBU® (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. If granted marketing authorization by the European Commission, DAYBU® would be the first therapy approved for this indication in the European Union (EU). “The CHMP’s positive opinion for DAYBU® is an important milestone in our mission to bring this innovative therapy to the EU, where there are no therapies specifically approved for the neurobehavioral symptoms of this devastating

HTEC Showcases Lakebase Branching at Databricks’ Data & AI Summit26.6.2026 11:18:00 CEST | Press release

HTEC, the global technology and AI engineering firm headquartered in Silicon Valley, last week showcased how it used Lakebase data branching to enable faster development, safer operations, and new possibilities for data-driven organizations operating in highly regulated environments. The Solution was developed in collaboration with a leading risk and compliance technology provider who serves financial institutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260626875859/en/ HTEC, the global technology and AI engineering firm headquartered in Silicon Valley, last week showcased how it used Lakebase data branching to enable faster development, safer operations, and new possibilities for data-driven organizations operating in highly regulated environments. Solving Critical Development Bottlenecks in Regulated Environments At the core of the collaboration was a shared challenge: how to enable modern data workflows in an envi

Stallergenes Greer Named One of Switzerland’s Best Managed Companies for 202626.6.2026 10:28:00 CEST | Press release

Stallergenes Greer, a global leader in allergy care, has been recognised for its overall business performance, company culture, and sustained growth by receiving the prestigious 2026 Switzerland’s Best Managed Companies award. The 2026 Best Managed Companies programme award winners are among Switzerland’s best private companies. The awards are derived from Deloitte’s global Best Managed Companies awards programme, an internationally recognised programme that evaluates businesses based on their leadership in the areas of strategy, culture and commitment, capabilities, innovation, governance and financial performance. Applicants are evaluated by an independent jury of experts. The evaluation of the Switzerland awards is based on more than 30 years of observed practice from the global awards programme that has been rolled out in 50+ countries worldwide. This recognition reflects Stallergenes Greer's consistent ability to deliver on its strategic vision while maintaining the operational di

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