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

(BUSINESS WIRE)-- 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 2^nd 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.

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