THIS ANNOUNCEMENT DOES NOT CONSTITUTE AN OFFER TO SELL OR SUBSCRIBE FOR, OR AN INVITATION TO OFFER TO BUY OR SUBSCRIBE FOR, SECURITIES. INVESTORS WILL NEED TO BASE THEIR INVESTMENT DECISION ON THE PROSPECTUS AND IN PARTICULAR THE RISK FACTORS AS DESCRIBED IN THE PROSPECTUS THAT MITHRA PHARMACEUTICALS SA EXPECTS TO PUBLISH AFTER THE APPROVAL OF THE PROSPECTUS BY THE COMPETENT BELGIAN SUPERVISORY AUTHORITY, AND WHICH CAN THEN BE OBTAINED AT MITHRA PHARMACEUTICALS SA’S REGISTERED OFFICE AND ON WWW.MITHRA.COM.
- Mithra targets the women’s health market which is an existing, well defined and large addressable market (EUR 33.6 billion globally in 2014 with a forecasted CAGR of 3.0%).
- Mithra’s development portfolio (1st pillar) includes the development of two Estetrol-based product candidates of which one in the oral contraception indication (Estelle®, ready for phase III) and one in the menopause indication (Donesta®, ready for phase II) and the development, directly or indirectly through Novalon (50% subsidiary of Mithra), of three generics of complex hormone-based prescription drugs.
- The estimated EUR 10.7 billion oral contraception and EUR 6.0 billion menopause markets1have been characterised by limited innovation whereby innovation primarily came from reformulations, dosage differentiation or altered drug delivery. Moreover, currently marketed drugs have known safety issues. Therefore, the Company believes there is a need for new innovative therapies. With Estelle® and Donesta®, Mithra targets 64 million females in the EU and US alone in 2014.
- In addition, Mithra has a commercial portfolio of in-licenced branded generics and OTC products (2nd pillar) which are commercialised in the Benelux. Mithra’s commercial franchise is market leader in Belgium (45.5% of volume) and the Netherlands (20% of volume in tender market) in the contraception market. This business model is being implemented internationally in Brazil and Germany (launch in 2015) and in France (launch in 2016). In a first stage Mithra will launch some products of its current commercial portfolio or in-licensed products in these countries.
- Mithra will operate its own state-of-the-art R&D and production facility (CDMO), which is currently under construction.
Commenting on today’s announcement:
François Fornieri, Chief Executive Officer and Co-Founder of Mithra: “This IPO is a next step in Mithra’s exciting lifespan. Since its inception Mithra has been supported by key opinion leaders and together we are convinced that our Estetrol patent family will improve overall quality of women’s life. Mithra is perfectly poised to take advantage of the global need in the Women’s Health market.”
Steven Peters, Chief Financial Officer of Mithra: “The proceeds from our IPO will allow us to develop our Estetrol pipeline in contraception and menopause and the complex generics portfolio. We believe our IPO will further support the strong momentum and visibility already established by Mithra through the recent entrance of pharma investors. ”
ING Belgium SA/NV and KBC Securities NV will act as the Joint Global Coordinators and Joint Bookrunners.
Subject to the approval of the prospectus by the competent Belgian supervisory authority and market conditions, it is expected that the size and the price range, as well as other details of the Offering, will be published in the Belgian financial press, when the Offering period is expected to commence.
The net proceeds from the Offering will be mainly be used by Mithra to continue the clinical development of the two Estetrol-based product candidates in the indications of contraception and menopause.
Key Advantages of Estetrol
Estetrol is a natural oestrogen produced at a high rate by the liver of the human foetus during pregnancy. From pre-clinical and Phase II results it appears that E4 might have number of important advantages compared to other currently used oestrogens:
- Reduced venous thromboembolism (VTE) risk profile: it appears that E4 alone or in combination with a progestin minimally impacts the synthesis of the relevant liver proteins
- Lower carcinogenic potential: E4 metabolisation has not been shown to produce active metabolites, including catechol oestrogens, which have been demonstrated to induce DNA damages
- No stimulation of normal or malignant breast cell growth at therapeutic doses.
- Lower risk of drug-drug interaction: E4 at a high concentration of 10 µmol/l does not inhibit (less than 10%) the major cytochrome P450 enzymes
- Lower risk of gallbladder disease: the elimination pathway of E4 is done through the urine (>95%) and not through the bile
- Minimal increase of triglycerides
Based on the special features of E4, Mithra believes E4 has potential in various women’s health indications though the successful development of Estetrol-based product candidates remains highly uncertain
 Source: Datamonitor