Publication date: 22/11/2017
Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today confirms the extended shelf-life of 36 months of its complex therapeutic product Tibelia®, as compared to 24 months for other currently available tibolone-based products.
Tibelia® is a generic version of Livial® developed by Mithra. The product is a synthetic steroid (tibolone) for use in hormone replacement therapy. This includes the relief of postmenopausal symptoms, in addition to prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products. These indications represent a global market of EUR 115.8 million1.
The 36-month shelf life extension of Tibelia® has been granted by MHRA 2 . As tibolone is a relatively unstable active ingredient, a unique formulation has been developed, for which an international patent application was filed in May 2017. The extended shelf-life offers a competitive advantage for distributors, as it allows them to optimize their supply chain management, while it may also allow patients to further space out their doctor’s visits.
Tibelia® is already on the market in the UK, Spain, the Netherlands, Italy and Sweden, through existing supply and license agreements signed in 2016 and 2017. Several other launches are expected in coming months.
François Fornieri, CEO of Mithra, commented:
“We are pleased with the 36-month shelf-life for Tibelia®, which is a validation of Mithra’s expertise and know-how to develop Complex Therapeutics. Given the competitive advantage offered to both distributors and patients, we expect that the extended shelf-life versus other tibolone-based products will positively contribute to the revenues for Tibelia®”.
Mithra (Euronext: MITRA) is dedicated to providing innovation and choice in Women’s Health, with a particular focus on fertility, contraception and menopause. Mithra’s goal is to develop new and improved products that meet women’s needs for better safety and convenience. Its two lead development candidates – a fifth generation oral contraceptive Estelle® and next-generation hormone therapy Donesta® - are built on Mithra’s unique natural estrogen platform, E4 (Estetrol). Mithra also develops, manufactures and markets complex therapeutics and offers partners a complete spectrum of research, development and specialist manufacturing at its CDMO.
Mithra was founded in 1999 as a spin-off from the University of Liège by Mr. François Fornieri and Prof. Dr. Jean-Michel Foidart. Mithra is headquartered in Liège, Belgium. Further information can be found at: www.mithra.com