These products will reinforce Mithra’s R&D capabilities, and represent an opportunity to become a leading player in Woman’s Health.
Estelle™, a new generation of Oral Contraception based on a natural compound in mid stage development
Estelle™ is a next generation combined oral contraceptive (COC) based on Estetrol (E4), a natural estrogen which the Company believes will provide a prolonged half-life, a higher safety margin, less interference with liver and metabolic functions and an improved side effect profile. Estetrol is being studied in combination with a progestin and will be developed in a convenient dosing regimen. Phase II studies have demonstrated a good contraceptive activity and bleeding profile.
This project Estelle™ is being developed for global markets, with an anticipated launch in 2019. It is estimated that more than 100 million women worldwide rely on oral contraceptive pills for routine contraception.
“E4 is a natural steroid, present at high levels during pregnancy, both in the mother and in the foetus. While potentially offering protection against deep venous thrombo-embolism (VTE) E4 may also produce less subjective side effects such as breast tension and tenderness, weight gain, edema, nausea, abdominal bloating, headache, mood changes that can exist when taking the currently marketed oral contraceptives” explains Professor Jean-Michel Foidart.
“E4 is the first known natural SERM (selective oestrogen-receptor modulator) and exhibits anti-oestrogenic effects on breast cancer in preclinical and clinical studies. E4 might be safer for the breast than standard oestrogens. Its favourable clinical side-effect profile implies that E4-containing new drugs should have a very beneficial favourable benefit-risk ratio,” comments Professor Herjan J.T. Coelingh Bennink, CEO and President | Pantarhei Bioscience, which initiated and co-developed Estelle.
Early Stage development opportunities
Mithra has acquired 3 additional potential programs in early stage development; including Alyssa™ a new generation hormonal IUD and Colvir™ which is being studied for the treatment of pre-malignant cervical lesions associated with HPV (Human Papilloma Virus).
“The acquisition of these products represents an excellent opportunity not only to expand our portfolio, but also to ensure that both the health care professionals and the patient community can benefit in the future from significant therapeutic advances,” emphasises Francois Fornieri, CEO of Mithra Pharmaceuticals.
Mithra will integrate the scientific workforce and will assume all of the ongoing obligations relating to the development programs.