In the 1st phase of public voting, 156,573 votes were received for the video entries posted by companies online, and Mithra Pharmaceuticals got the highest number of votes for Belgium. It was chosen out of 709 other businesses, and is one of 33 National Public Champions announced today from countries across Europe.

The National Public Champions were celebrated at a Gala Event on 26 May 2015 in London, where François Fornieri, CEO of Mithra Pharmaceuticals, received the National Public Champion of Belgium medal.

“We are extremely proud to be named the National Public Champion of Belgium”, explains François Fornieri, “the European Business Awards is widely recognised as the showcase for Europe’s most dynamic companies. We are proud of what we achieved today.”

Adrian Tripp, CEO of the European Business Awards said: “It is a fantastic stamp of approval to be voted best in class by the public, and this voting stage has provided a wonderful opportunity to engage clients, staff, stakeholders, and potential new customers. Well done to all our National Public Champions.”

The European Business Awards is an independent Awards programme designed to recognise and promote excellence, best practice and innovation in the European business community. This year it engaged with over 43,000 businesses from 33 European countries. It is now open for entrants for the 2015-16 competition.

For more information and review the video entries please visit www.businessawardseurope.com.

Two months after acquiring the rights to Estetrol in the field of oral contraceptives and the recent capital inflow from M. Coucke, Mithra Pharmaceuticals is once again consolidating its innovation portfolio, this time by acquiring full rights to Estetrol from Pantarhei Bioscience. This agent offers therapeutic prospects perfectly in keeping with the four main spheres of gynaecology covered by Mithra Pharmaceuticals.

“Mithra is a pharmaceutical company focused on women’s health. Through our products and Research & Development projects, we cover the four major spheres of gynaecology, namely fertility and contraception, the menopause and osteoporosis, gynaecological infections, and also cancer. The acquisition of Donesta gives us the opportunity to operate several patents in three of our four therapeutic areas. This is major progress in our company’s position,” explains François Fornieri, CEO of Mithra Pharmaceuticals.

Pantarhei Bioscience will receive an initial payment, together with milestones based on the successful development of projects relating to the menopause.

Mithra Pharmaceuticals will grant Pantarhei Bioscience a licence for the development of human applications in oncology and veterinary applications. The Dutch firm will study therapies for reproductive organ cancers, such as ovarian cancer and breast cancer. Mithra will have the right to first refusal should Pantarhei Bioscience undertake partnership negotiations.

Professor Herjan Coelingh Bennink, CEO of Pantarhei Bioscience, will be on the board of Mithra Pharmaceuticals and will become Co-Chairman of the scientific committee.

“We are delighted about this acquisition which has given Mithra Pharmaceuticals additional essential assets. Mithra intends to focus initially on the applications relating to contraception and the menopause, two essential and extremely dynamic markets,” declares François Fornieri, CEO of Mithra Pharmaceuticals.

About Estetrol

Estetrol (E4) is a natural oestrogen produced in large quantities by the human foetal liver. The role of E4 in embryonic physiology and/or human pregnancy has not yet been determined. E4 passes into the maternal blood circulation via the placenta. E4 can be detected from the ninth week of pregnancy. Maternal and foetal E4 concentrations increase exponentially throughout pregnancy, reaching their maximum at term, when the foetal concentrations recorded are approximately 10 to 20 times higher than maternal levels. This natural evidence during the most vulnerable physiological situation that exist tends to suggest the superior safety of this substance.

Result of preclinical studies

The pharmacological profile of E4 was characterised in detail by Pantarhei Bioscience in the context of a series of preclinical studies. E4 has revealed several major potential advantages relative to the oestrogens currently used, such as conjugated equine oestrogens (CEO), estrone (E1), estradiol (E2), estriol (E3) and ethinylestradiol (EE). During oral administration, E4 acts an oestrogen at vaginal, uterine and bone level, demonstrating a profile “which preserves the hepatic environment”. Furthermore, E4 eliminates hot flushes and prevents ovulation. More surprisingly, E4 acts as an oestrogen antagonist in breast tissue. In a validated rat model, it was shown to be able to prevent the development of breast tumours and eliminate pre-existing breast tumours in the presence of estradiol (E2).

“The key characteristic of Estetrol is its differentiated action mechanism according to tissue. This is known as ‘SERM’ (selective oestrogen receptor modulator),” explains Herjan Coelingh Bennink, CEO of Pantarhei Bioscience. “Estetrol acts both as a relatively potent oestrogen on certain types of tissue such as the vaginal mucosa, bone and brain – which explains the effect on hot flushes and inhibition of ovulation –, whereas it has a neutral effect on other types of tissue such as the liver – hence the fact that it does not stimulate coagulation and does not increase the risk of thrombosis and embolism. Lastly, it has an anti-oestrogen effect on breast tissue. We therefore have access to an oestrogen without any negative consequences on coagulation and which does not appear to have any consequences on breast cancer”.

Result of clinical studies

Studies have shown that, once administered to post-menopausal women, E4 effectively reduces the frequency of hot flushes and nocturnal sweating. The results of phase 1 studies also prove that E4 does not appear to stimulate breast cancer and could even exert an inhibitory effect. Lastly, E4 has a positive action on bone metabolism and could therefore be used in the context of the prevention or treatment of osteoporosis. These results support the development of hormone replacement therapy (HRT) containing E4 in the hope of maintaining the current benefits of HRT (reduction in hot flushes, improvement in bone quality and quality of life) while reducing the risk profile (cardiovascular disease, thrombosis, embolism and breast cancer).

About the menopause

“Estetrol is very promising in the field of the menopause: It relieves vasomotor symptoms, unpleasant hot flushes and, at low doses, stimulates keratinocyte proliferation in the vaginal mucosa, which makes it a potential treatment for vaginal atrophy and urogenital complaints (micturition disorders, dyspareunia, and vaginal dryness).[1] Until now, short-term studies have been conducted, with small numbers of women, but are generating positive results. The next step is to investigate for the ideal dose (phase II studies), which will be followed by a study including a larger number of female patients. In order to implement and finance this development, we have found Mithra to be a solid partner, recognised in the field of women’s health,” explains Herjan Coelingh Bennink, CEO of Pantarhei Bioscience.

About Pantarhei Bioscience

Pantarhei Bioscience is a Dutch pharmaceutical company created in 2001, specialising in the development of innovative therapeutic approaches in the fields of women’s health and cancer therapies. Guided by a clear goal for innovation, the company develops and patents totally innovative therapeutic concepts based on existing compounds. An innovative vision is applied throughout preclinical and clinical studies, until proof of the clinical feasibility of the concept is achieved, and the next step is always entrusted to a partner.

[1] 1. Visser M, Coelingh Bennink HJT. Clinical applications for estetrol. J Reproductionsmed Endocrinol 2010;7(Sonderheft 1):56-60.

 

  • Mithra Pharmaceuticals raises an additional 40 million euros by including Marc Coucke in its capital.
  • Marc Coucke will chair Mithra’s strategic committee in anticipation of an initial public offering in 2015.

2015 will evidently be a key year for the Mithra group which has recently announced the takeover of certain R&D projects from Utéron Pharma in early January.

The acquisition of these 4 research projects with high added value includes Estelle, a next-generation combined oral contraceptive (COC) containing a natural oestrogen, Estetrol (E4) touted as the Group’s future flagship product.

Since 2014, Mithra has also been investing in the north of the country so as to consolidate its visibility in Flanders, meeting with potential investors. Despite the fact that the two men have known about and kept up-to-date with each other’s progress for a long time, François Fornieri, the Walloon Marc Coucke, and Marc Coucke, the Flemish Fornieri, have finally met.

With input from Marc Coucke, Mithra Pharmaceuticals clearly intends to challenge the world of gynaecology with an agent like Estetrol.

Marc Coucke, who has recently invested in Bart Versluys’ property projects, had promised to invest in a business with which he was more familiar. It is therefore natural for the CEO of Omega Pharma to be interested in Mithra’s success story.

“Before committing myself, I spoke to numerous pharmacists, doctors and also bankers, and Mithra has a very good reputation,” explains Marc Coucke.

A promising project

The Flemish business man is investing 40 million euros in total. This is a sensational introduction into the Mithra shareholder team which has already managed to raise a total of 63 million euros in one year, thus making it possible to finance the construction of its future development and production centre in Flémalle.

The 40 million euros invested by Marc Coucke will mainly be injected into the Estelle™ project, a next-generation combined oral contraceptive (COC) containing a natural oestrogen, Estetrol (E4), the pharmacokinetic and pharmacodynamic profile of which is expected to be favourable for women’s health, and for which the safety and tolerability profile represents a major breakthrough in the field of contraception. Studied in combination with a progestogen, the results of the phase II studies demonstrated both good contraceptive activity and a favourable impact on the patient bleeding profile.

“Found at high levels during pregnancy, E4 is a natural steroid produced by the human foetus. While potentially conferring protection against the risk of deep-vein thromboembolism, E4 is also said to give rise to fewer subjective side effects such as: tender breasts, weight gain, oedema, nausea, abdominal bloating, headaches and mood changes which may be encountered when taking the oral contraceptives currently on the market,” cites Professor Jean-Michel Foidart.

“E4 is the first known SERM (selective oestrogen-receptor modulator) and displays a proven anti-oestrogen activity in the field of breast cancer both at preclinical and clinical level. E4 is said to display an improved safety profile compared with standard oestrogens. Its favourable clinical profile in terms of side effects suggests a beneficial and highly favourable benefit/risk ratio for future medicinal products containing E4,” expands Professor Herjan J.T. Coelingh Bennink, CEO and Chairman of Pantarhei Bioscience, initiator and co-developer of Estelle™.

The worldwide market launch of Estelle™ is expected in 4 or 5 years. More than 100 million women are currently estimated to use regular oral contraceptives.

A strategic partnership

“We are going to benefit from Marc Coucke’s experience to broaden our Benelux portfolio, but also to open doors to new markets,” explains François Fornieri, CEO of Mithra Pharmaceuticals.

Marc Coucke will join and chair the firm’s strategic committee as from February 26, and will lend his expertise to the national and international development of the Group.

“The synergism between the Walloon Coucke and Flemish Fornieri can only be successful!” explains Marc Coucke, Mithra’s new shareholder. “I felt this from the first meeting with François Fornieri and his team. Together, we will help Mithra’s structure to evolve. In my role as chairman of the strategic committee, I will be able to intervene to varying degrees in an operational manner on issues such as budget, preparation of the IPO and the Group’s next acquisitions. Together, we will aim for astounding success. Mithra offers a unique combination with profitable business activities based on strong growth, with great potential, and a somewhat biotech business activity which could create a blockbuster. Hence, Mithra has every asset in order to achieve both short-term and long-term success. Furthermore, Mithra is investing in R&D in Wallonia, and I am delighted to be able to contribute to the economic development of Wallonia!”

“Marc Coucke and I have a great deal in common. We both put the same passion into everything we do, we both love art, football, etc., and our career paths are somewhat similar, hence, this professional partnership is very natural. It is incredible how quickly we reached an agreement. The Flemish Fornieri and the Walloon Coucke clearly speak the same language.”

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.

For several years now, Mithra has been investing in football by sponsoring Standard Club (men’s and women’s team) together with Club Brugge. These two clubs share a history and common values with Mithra. From the outset, the company has perceived football as a means of opening up to new networks, and also to promote women, its core business, in all aspects of daily life, including male-dominated sports.
<h2>National visibility</h2>
This new partnership between Mithra and Club Brugge completely falls within the scope of the development ambitions of the Liège spin-off, particularly with the capital-raising it envisages.

Better known in Wallonia than in Flanders, Mithra above all sees itself as a Belgian company. This is why the company wishes to develop and consolidate its notoriety in Flanders, through greater visibility to the general public and potential industrial and financial partners. This new partnership can obviously contribute to this goal.
<blockquote>“For many years now, we have been supporting women’s sports clubs which are developing in male-dominated sports such as basketball and football. The connection with our core business, women’s health, is undeniable”, emphasises François Fornieri, CEO of Mithra Pharmaceuticals and a passionate football supporter. “Mithra notably owes its success to its local roots in Belgium. Sport brings people together, throughout the world. By sponsoring sports teams, Mithra wishes to be a part of society. This is also particularly motivating for company employees who are inspired by “our” clubs’ performance. This motivates them and strengthens our team’s cohesion and dynamism.”</blockquote>