Notice of 2018 Extraordinary General Meeting Regarding Proposed Warrant Plan

Liège, Belgium, 5 October 2018 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces its intention to hold an Extraordinary General Meeting (“EGM”) on the 5 November 2018 at 11:00 am in Flémalle, 57 rue de l’Expansion (Belgium). The meeting will consider a new warrant plan whereby a maximum of 1,881,974 warrants would be issued, subject to shareholder approval.

 

Presentation of Donesta® PhIIb Results at the 2018 Annual Meeting of the North American Menopause Society

Liège, Belgium, October 3nd 2018 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces its Phase IIb results for Donesta® will be presented at the 29th Annual Meeting of the North American Menopause Society (NAMS), being held on 3-6 October 2018 in San Diego, CA.

 

Mithra Signs Exclusive License and Supply Agreement for the Commercialization of Myring™ in Chile with Laboratorio Pasteur

Liège, Belgium, 26 September 2018 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, is pleased to announce the finalization and signature of the contract with Laboratorio Pasteur S.A., a Chilean pharmaceutical company also devoted to women’s health, for an exclusive License and Supply Agreement (LSA) to commercialize Myring™ in Chile.

Mithra Announces 2018 Half Year Results

Liège, Belgium, 25 September 2018 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces its financial results for the six-month period ending 30 June 2018, prepared in accordance with IFRS. The full interim report is available on the Investors section of the website.

 

Mithra Finalizes Contract for the Commercialization of Estelle® with South Korean Women’s Health Leader Hyundai Pharm

Liège, Belgium, 24 September 2018 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, is pleased to announce the finalization and signature of the contract with Hyundai Pharm, a South Korean Women’s Health leader, for an exclusive license and supply agreement to commercialize Estelle® in South Korea. The signature follows the binding Heads of Terms agreement previously announced on 5 June 2018.

 

Mithra Signs Exclusive License and Supply Agreement for Commercialization of Tibelia® in Taiwan

Liège, Belgium – 21 September 2018, 07:30 CEST – Mithra Pharmaceuticals (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announced that it has entered into an exclusive license and supply agreement with Pei Li Pharmaceutical Industrial Co, Ltd (“Pei Li Pharm”) to commercialize Tibelia® in Taiwan.

Mithra and Richter Sign License and Supply Agreement for Commercialization of Estelle®, a Novel Oral Contraceptive

Liège, Belgium – 12 September 2018, 7:30 CEST – Mithra Pharmaceuticals (hereinafter: “Mithra”) and Gedeon Richter Plc. (hereinafter: “Richter”) today announced that they have entered into a license and supply agreement to commercialize Estelle®, a combined oral contraceptive (COC), containing 15 mg Estetrol (E4) / 3 mg drospirenone (DRSP), in Europe and Russia. Richter will commercialize the product under a different brand name. The product is a novel combined oral contraceptive with natural, native estrogen acting selectively in tissues combined with drospirenone’s non-contraceptive benefits.

Under the terms of the agreement Richter will make, upon signature of the contract, an upfront payment totaling EUR 35 million. Additional milestone payments amounting to EUR 20 million will be made depending on the progress of the regulatory process of the product. Further sales-related royalties will be payable to Mithra subsequent to the launch of the product. Moreover, Mithra will receive guaranteed annual recurring revenues based on minimum annual quantities (MAQ), in addition to tiered royalties on net sales.

François Fornieri, CEO of Mithra Women’s Health commented : “We are very pleased to have agreed terms with Richter for the commercialization of our next generation oral contraceptive product candidate Estelle® in Europe and Russia. This is by far the biggest contract in Mithra’s history. As an undisputed leader in Women’s Health, with a rapidly expanding direct presence in Western Europe, we are confident that Richter is the best possible partner for Estelle® in this important geography. We are looking forward to a fruitful and long-term collaboration with the Richter team. Today’s news further reinforces our confidence in our ability to sign a future partnership for Estelle® in the US, where the oral contraceptive market is valued at twice the size of the European market.”

Gábor Orbán, CEO of Gedeon Richter Plc, added : “Broadening our core Women’s Healthcare portfolio remains a paramount objective of Richter’s strategy aiming towards the improvement of the quality of life of the female population in all age groups. This agreement fits into this endeavour and we look forward to a successful cooperation with Mithra in the commercialization of a novel oral contraceptive.”

Mithra Announces Positive Top-Line Results of Estelle® Phase III Oral Contraceptive Study in EU/Russia

  • Primary efficacy endpoint indicates excellent contraceptive efficacy, with a Pearl Index (PI) of 0.48 per 100 women, exceeding efficacy goals
  • Key secondary endpoints achieved, including outstanding bleeding profile, cycle control, quality of life and safety and tolerability
  • Estelle® Phase III stsudy in US/Canada on track to report top-line results in Q1 2019
  • Data further support Estelle® as a novel, next-generation combined oral contraceptive for women

Liège, Belgium, 8 August 2018, 07:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announced that its Phase III Estelle® study conducted in Europe and Russia successfully met its primary efficacy endpoint. Estelle® is Mithra’s combined oral contraceptive (COC) candidate, composed of Estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg.

Mithra Announces Belux Agreement with Ceres Pharma Worth over EUR 40 Million

  • Mithra to receive EUR 20 million upon signing, with further EUR 20 million in potential additional earn-outs
  • Agreement covers the sale of the Women’s Health branded generics business in Belgium and Luxembourg as well as License and Supply agreements for certain Mithra assets in the region
  • Divestment of BeLux portfolio in line with Mithra’s strategy to realize the value of its noncore assets and fully focus on its key value-driving pipeline
Liège, Belgium, 30 July 2018, 7:30 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that it has signed a comprehensive BeLux partnership with Ceres Pharma, a Belgium-based company focused on over-the-counter (OTC) and specialist healthcare.

Mithra Obtains First Marketing Authorization for Myring™ in Europe

  • Marketing authorization allows for launch of Myring™ in the United Kingdom
  • Additional marketing authorizations expected in the near future
  • Mithra to produce Myring™ at its CDMO
Liège, Belgium, 20 July 2018 – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that the company obtained its first marketing authorization (MA) for Myring™  in the UK, following approval by the MHRA . Myring™ is Mithra’s contraceptive vaginal ring made of ethylene vinyl acetate copolymers (EVA) and is developed to be fully bioequivalent to Merck’s Nuvaring®.  In April 2018, Nuvaring® went off patent in both the US and Europe. In the UK, which is a market worth approximately EUR 1.2 million , no generic competition exists as of yet.