Mithra Signs License and Supply Agreement for Commercialization of Tibelia® in Italy

Tibelia® is a complex oral formulation composed of tibolone, a synthetic steroid for use in hormone therapy. Tibolone relieves postmenopausal symptoms and prevents osteoporosis in postmenopausal women at high risk of future fractures who are intolerant to other medicinal products. To date, Tibelia® is marketed in approximately 13 countries through existing license and supply agreements. 

Under the terms of this agreement, Farmitalia will be responsible for the commercialization of Tibelia® in Italy, which has a tibolone market worth approximately EUR 4.5 million per year1. Established in 1995, Farmitalia today represents an established reality in the national and international pharmaceutical world. Farmitalia manages many therapeutic areas, among which gynecology represents the crown jewel, and is leader in the manufacture of products containing palmitoylethanolamide (PEA). The concern for women’s health has led the company to deal with contraception and menopause, thus offering support to women during every important stage of their lives.

François Fornieri, CEO Mithra Women’s Health, commented: “We are pleased to have formed a partnership with Farmitalia for the commercialization of Tibelia® in Italy. This agreement is part of a broader strategy to identify the best possible partners to maximize the potential of Tibelia® and our portfolio of promising women’s health products around the world.”

About Mithra

Mithra (Euronext: MITRA) is a Belgian biotech company dedicated to transforming Women’s Health by offering new choices through innovation, with a particular focus on contraception and menopause. Mithra’s goal is to develop products offering better efficacy, safety and convenience, meeting women’s needs throughout their life span. Its three lead development candidates are built on Mithra’s unique native estrogen platform, Estetrol (E4): Estelle®, a new era in oral contraception, PeriNesta®, the first complete oral treatment for perimenopause and Donesta®, the next-generation hormone therapy. Mithra also develops and manufactures complex therapeutics in the areas of contraception, menopause and hormone-dependent cancers. It offers partners a complete spectrum of research, development and specialist manufacturing at its technological platform Mithra CDMO. Active in more than 85 countries around the world, Mithra has an approximate headcount of 250 staff members and is headquartered in Liège, Belgium. www.mithra.com

About Tibelia®

Tibelia® is a synthetic steroid (tibolone) intended to be used for hormone replacement therapy. Tibelia® is a bioequivalent of Livial® 2.5mg which is a product that mimics the activity of the female sex hormones in the body, and is used especially for the relief of symptoms occurring after menopause. In some countries, this product is also used for the prevention of osteoporosis. It has been demonstrated that tibolone has favourable effects on various tissues in the body, such as brain, vagina and bone2.