Thursday July 30th 2020



Mithra, a company dedicated to Women’s Health, announces the commercial launch of tibolone-based product Tibelia® in Canada. Developed by Mithra as the bioequivalent version of Livial® , Tibelia® is a synthetic steroid that relieves postmenopausal symptoms and prevents osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of other medicinal products. Mithra’s product is marketed by BioSyent Pharma Inc. in Canada under the trademark name Tibella®.

Mithra’s product is the first tibolone-based product provided to menopausal Canadian women, offering an innovative solution with a proven safety profile.

“Available hormonal treatment options for menopausal vasomotor symptoms, while generally effective, are often accompanied by side effects. As a result, many women discontinue therapy. Tibolone has unique properties that allow it to be used alone without the need for progestin co-therapy. It has been in use in Europe for the treatment of menopausal symptoms for many years and has a proven efficacy, tolerability and safety profile”, commented Dr. Robert Reid, MD, Gynaecologist and Professor Emeritus at the Department of Obstetrics and Gynaecology, Queen’s University.

In Canada, almost 4 million women between the ages of 45 and 59 have gone through or will soon go through menopause. The Canadian menopausal health market is currently valued at approximately CAD $200 million (EUR 132 million) per year, with further growth potential as new products are introduced, offering a promising opportunity for Tibelia®. The agreement with BioSyent Pharma Inc. will generate additional revenues for Mithra through sales related milestone payments. Already commercialized in about 30 countries, Tibelia® is now present for the first time on the North American continent, which should facilitate access to the major U.S. market. There are currently no tibolone-based products available on the U.S., where the menopausal market is worth USD 2.9 billion (EUR 2.5 billion) per year.

François Fornieri, CEO Mithra Women’s Health, commented: “We are delighted to provide Canadian physicians and women with a new treatment option to safely and effectively address menopausal symptoms. Our product is already present in many countries around the world, but its introduction on the North American continent was eagerly awaited and should now make it easier for us to enter the crucial U.S. market.”