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®

2013

Incorporation of Mithra Pharmaceuticals CDMO by Mithra RDP

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®

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