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Mithra A leader in women’s health

Last year marked Mithra’s 20th anniversary. As a biotech dedicated to transforming women’s health, Mithra offers new choices through innovation with a focus on contraception and menopause. Active in more than 85 countries, its presence on the world stage will be further strengthened to consolidate its status as a leading company for innovation in women’s health. Listed on Euronext Brussels since June 2015, Mithra today has reached a market capitalization of just over a billion euros – the first company in the Walloon region to reach this milestone.

Mithra Pharmaceuticals was co-founded in 1999 by François Fornieri and Prof. Dr. Jean-Michel Foidart as a spin-off of the University of Liege, where Prof. Foidart was the former head of Gynecology and Obstetrics. He also played an instrumental role in several major developments in women’s health, including the development of the world’s second hormonal IUD and the development of an oral contraceptive containing drospirenone – which remains one of the world’s best-selling oral contraceptives.

Innovative solutions for women

Mithra’s R&D activities are structured along two lines. The first deals with the development of a platform based on Estetrol (E4), a native estrogen produced by the human fetus during pregnancy. Thanks to its unique profile, E4 potentially represents a breakthrough in various therapeutic fields like contraception and menopause. Today, Mithra focuses on the development of three late-stage E4-based potential blockbusters: Estelle ® , a new era in oral contraception, PeriNesta ® , the first complete oral treatment for perimenopause and Donesta ® , a next-generation hormone therapy.

Estelle ® , a combined oral contraceptive, combines E4 with the progestin drospirenone. Its mechanism of action is unique and the clinical benefits are apparent: a long half-life, high bioavailability, and a very limited hepatic impact regarding hemostasis, with a limited risk for venous thrombosis. It combines contraceptive efficacy with excellent cycle control and presents a minimal risk of drug-drug interaction and a limited impact on the breast. Furthermore, it is weight neutral. With its improved benefit/risk profile, Estelle ® is a potential blockbuster in the contraceptive market, which is worth about USD 24 billion a year worldwide and has a compounded annual growth rate of about 6%. Estelle ® has successfully completed its Phase III studies and is entering its final review period with the regulatory agencies before being launched worldwide in 2021.

Donesta ® , a next-generation hormone therapy, aims to replace the estrogen that is no longer naturally produced by the body, once a woman has become menopaused. Symptoms such as hot flushes can be quite disabling in everyday life. However, due to a fear of the side-effects caused by traditional hormone therapies, only a small percentage of women treat their symptoms. Entering its final clinical phase, Donesta ® could offer women a real alternative, given its unique mode of action. The global menopause market currently stands at USD 12.6 billion and is expected to grow to approximately USD 16 billion by 2025. If approved, Donesta ® could capture a substantial part of this growing market where there is a high unmet need.

The third potential blockbuster, PeriNesta ® , could become the first product on the market for perimenopausal women. Today, there is not one combined solution available to address the first menopausal symptoms of hot flushes in combination with a contraceptive. Perimenopause represents a multi-billion USD market.

The safety margin and tolerability of Estetrol (E4) present an opportunity to investigate its use in other areas of women’s health such as oncology (hormonal cancers), emergency contraception and osteoporosis. Mithra also intends to explore additional indications for E4 such as wound healing and pediatric neuroprotection, for which orphan drug designation (ODD) was granted for the treatment of neonatal encephalopathy.

State-of-the-art R&D and Manufacturing platform

The second pole of Mithra’s R&D activities relates to its Contract Development and Manufacturing Organization (CDMO) that focuses on three main areas: polymer technologies (rings, IUDs, implants), sterile injectable formulas (vials, cartridges, prefilled syringes) and hormonal tablets. From Proof-of-Concept to the first commercial batches, the flexible platform of Mithra CDMO provides a one-stop shop that is open to third parties requiring small to medium-sized batches. It also provides various services,

including analysis, production, logistics, quality assurance, development and formulation.

The Mithra CDMO technology platform is notable for its development of long-acting therapeutic solutions using medical polymers, with durations ranging from one month to five years. The solutions include a subcutaneous implant to treat prostate, breast and endometrial cancer. This is in line with the recommendation of the World Health Organization (WHO), that encourages the development of long acting therapeutic solutions to improve health outcomes, while reducing budgetary impact. Mithra will continue working with external partners to develop slow-release solutions – a market that is even more promising because medical polymers are still insufficiently explored and under-used in important areas, such as oncology, contraception and infectious diseases.

Mithra Pharmaceuticals Rue Saint-Georges 5-7 - B-4000 Liège Tel.: +32 (0)4 349 28 22 - Fax: +32 (0)4 349 28 21 Email: info@mithra.com - https://www.mithra.com