Mithra's exclusivity on Estetrol applications extended to 2036 in Europe
Mithra, a company dedicated to Women’s Health, announces that it has been granted a new patent by the European Patent Office (EPO) relating to various pharmaceutical compositions containing Estetrol (E4) and their manufacturing process. In doing so, Mithra consolidates its exclusivity for the use of E4 in a wide range of indications such as the treatment of hormone-dependent cancers (breast and prostate in particular), dermatology, neuroprotection, dysmenorrhea and emergency contraception.
Since its creation, Mithra's ambition has been to transform the women's health sector by developing innovative products offering better efficacy, safety and convenience, meeting women’s needs throughout their life span.
Following fruitful research, Mithra identified the health benefits of E4 and its countless potential applications, particularly in contraception and menopause treatment. Thanks to its unique mode of action, this native estrogen, recently recognized as New Active Substance (NAS) by EMA, is distinguished by a significant reduction of side effects that women suffer with conventional estrogens. Thanks to the exploitation of Estetrol, Mithra is developing two particularly innovative product candidates: Estelle®, a new era in combined oral contraception, and Donesta®, a newgeneration hormonal treatment for vasomotor symptoms of menopause.
Based on the various results of preclinical and clinical research conducted to date, which confirm the efficacy of E4 in various therapeutic indications, Mithra has implemented an intellectual property strategy aimed at regularly patenting the various applications of E4 as well as the synthesis process of the molecule. The stakes are high: the world contraception market is worth €22 billion and it is estimated that 30% of women do not take the pill because they do not tolerate its side effects; the menopause market is valued at nearly €13 billion and less than 10% of women resort to treatment for fear of side effects.
Falling within this strategy the recent decision of the European Patent Office (EPO) to grant Mithra a new patent related to Estetrol, extends and reinforces the 35 patent-family portfolio filed by the Belgian biotech company worldwide. Concretely, this decision guarantees Mithra effective exclusivity of Estelle® and Donesta® product candidates until 2036 in Europe. As far as the United States is concerned, a similar patent application has been filed by Mithra and is currently being examined by the United States Patent & Trademark Office (USPTO). In doing so, Mithra secures and strengthens the earnings prospects of its various Estetrol related products once they are approved for sale.
François Fornieri, CEO of Mithra Women’s Health, commented: "The approval of this new patent by the European Patent Office is another important step in the commercialization strategy of our products. With a total of 35 patent families filed worldwide, 14 more families than at IPO, we have strong intellectual property protection around Estelle® and more broadly around our portfolio of Estetrol-based products. In parallel with the steps linked to their market launch, it is imperative to work towards their effective protection. By protecting our innovations from any possible competition, this protection is the best guarantee we can have of our future ability to generate results that meet our expectations.”