History

Today

Mithra Pharmaceuticals is pursuing its major R&D projects and is strengthening its activities initiated in each of the earlier phases.

Innovation: Mithra Pharmaceuticals reveals its technological know-how

In the third phase of the development of Mithra Pharmaceuticals, starting in 2014, the company added a focus on innovation and development, spearheaded by its development of Estetrol in contraception and menopause, and its development of complex therapeutics. This third phase is currently ongoing.

  • 2018

    Completion of E4Freedom Phase III study for Estelle (Eu/Russie & US/canada).

    LSA with Gedeon Richter for the commercialization of Estelle in Europe and Russia.

    Positive topline results announced for Estelle Phase III Eu/Russia.

    Valorisation of the Belux generics business – Agreement worth over 40 million € with Ceres Pharma.

    First MA for Myring in Europe (UK).

    Mithra Raises EUR 77.5 Million.

    17/05/18 Valorization of Mithra reaches 1 billion $.

    Positive topline results for Donesta Phase II E4Relief study.

    Very promising phase 2 hemostasis results announced for Estelle.

  • 2017

    Recruitment completed into Donesta® Phase II study

    LSA with Fuji Pharma signed for Donesta® in Japan & ASEAN, as well as a commercialization agreement with Libbs for Estelle® in Brazil

    EUR 26.1 million Private Placement in June 2017

    Orphan Drug Designation from EMA received for E4 in Neonatal Encephalopathy

    GMP approval received for Myring™ production at Mithra CDMO, followed by submission of MA for Myring™ in Europe

    LSA signed with Mayne Pharma for commercialization of Myring™ in the US, as well as LSA with Gynial for commercialization of Myring™ in Austria

    Recruitment completed into the Estelle® Phase III E4 Freedom EU/Russia and US/Canada study

  • 2016

    Tibelia® launched in a number of European countries following receipt of Marketing Authorizations in 14 European countries

    Signing of first LSA for Estelle® with Fuji Pharma in Japan & ASEAN

    Marc Coucke appointed Chairman of the Board of Directors

    Official opening of the Mithra CDMO on September 30, 2016

    Estelle® Phase III studies in contraception, E4 Freedom, launched in Europe/Russia and US/Canada

    Donesta® Phase II study in menopause, E4 Relief, launched in Europe

  • 2015

    Mithra fully acquires Novalon,
    bringing the shareholding of Mithra to 100%

    Incorporation of Mithra Pharmaceuticals SAS (France)

    Acquisition of worldwide rights for Estetrol
    in the contraception indication (Estelle®) via
    the acquisition of Estetra SPRL and three other
    early stage projects (Colvir, Vaginate and Alyssa)
    from Actavis, following their de-prioritisation.
    Hiring of the majority of the key Actavis Belgium
    (ex Uteron Pharma) female healthcare R&D
    staff involved in the projects acquired

    Successful completion of bioequivalence studies
    for Tibelia® (generic of Livial®). Two Decentralised
    Procedures (DCP) are currently ongoing.

    EUR 54.6 million financing round, led by Marc Coucke.
    Other investors joining were Bart Versluys, SRIW,
    various family offices and existing investors in the
    Company, including Meusinvest and certain members
    of the Company’s management.

    Acquisition of all rights related to Estetrol
    not yet acquired from Actavis earlier in the year
    from Pantarhei Bioscience (e.g. Donesta®)

  • 2014

    EUR 11 million financing round

    Acquisition of Fibrocis (now Mithra do Brasil)(Brazil) by Mithra IBD

    Acquisition of Mithra IBD SA and Mithra RDP SA (Belgium)

    Acquisition of 25% of Novalon

    Secured financing for phase1 of construction and started construction
    of the development of its Contract Development Manufacturing
    Organisation (CDMO) (Belgium)

    Start of bioequivalence studies for Tibelia®

Branded generics: Mithra Pharmaceuticals is recognised as an expert in gynecology in Benelux and beyond

In the second phase, as from 2004, Mithra Pharmaceuticals began developing its first generic hormonal drugs and focusing on the commercialisation of its branded generics, which allowed it to build up its business development organisation and become recognized, both in Benelux and internationally, as a specialist in the women’s health care sector having a very strong know-how in the development of complex products.

  • 2013

    Incorporation of Mithra Pharmaceuticals CDMO by Mithra RDP


    Incorporation of Mithra Deutschland GmbH (Germany)
    by Mithra IBD


    Acquisition of WeCare (now Mithra Pharmaceuticals BV)
    (the Netherlands) by Mithra IBD


    First optimisation of the synthesis pathway of Estetrol
    by Estetra SPRL

  • 2012

    Novalon entered into worldwide, exclusive co-operation, license
    and profit-sharing agreements with GSP for two of its principal
    complex generic products, Zoreline® and Myring®


    Estetra SA (later to be transformed into Estetra SPRL) reported
    positive Phase II clinical results for Estelle®

  • 2010

    Estetra SA initiated dose-finding Phase II clinical trials for Estelle®

  • 2008

    Pantarhei Bioscience started and successfully completed
    a Phase IIa feasibility trial in contraception for Estetrol

  • 2007

    Donesta® reported positive Phase I results for Estetrol

  • 2005

    Incorporation of Novalon, for the development of complex generics,
    by François Fornieri

  • 2004

    Commercial launch by Mithra in Belgium of one of the world’s
    first generic contraceptive pills containing cyproterone acetate
    in combination with ethinylestradiol

The early spin-off years. Mithra Pharmaceuticals as new player in Women’s Health

The first phase began in 1999 when Mithra Pharmaceuticals was founded by entrepreneur François Fornieri and Prof. Dr. Foidart, as a spin-off of the University of Liège.

The Company began by targeting gynecologists with a range of personal hygiene products, food supplements, medical devices and over-the-counter products, an initial product range enabling the new company to build up a reputation with professionals in the Women’s Health sector, and working with established pharmaceutical groups in the launch of their new products in this sector in Belgium.

  • 1999

    Mithra, spin-off from the University of Liège,
    founded by François Fornieri and Prof. dr. Jean-Michel Foidart