Mithra and Mediner Sign LSA for Tibelia® in Hungary

  • Mithra grants exclusive license for Tibelia® to Mediner for commercialization in Hungary
  • Tibelia® is currently marketed in a 8 countries through existing license and supply agreements
  • Further Tibelia® launches anticipated in 2018

Liège, Belgium, 13 July 2018 –  Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces an exclusive license and supply agreement (LSA) with Mediner for the commercialization of Tibelia® in Hungary.

Mithra and Orifarm Sign LSA for Vaginal Contraception Ring in Denmark

  • Mithra grants exclusive license for vaginal contraception ring to Orifarm for commercialization in Denmark/li>
  • Agreement follows MyringTM licenses closed with Mayne Pharma, Gynial, Adamed and Alvogen for the US, Austria, the Czech Republic and Russia, respectively
  • Vaginal ring shall be manufactured at Mithra CDMO

Liège, Belgium, 21 June 2018 –  Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces an exclusive license and supply agreement (LSA) with Orifarm for the commercialization in Denmark of Mithra’s contraceptive vaginal ring product candidate made of ethylene vinyl acetate copolymers (EVA).

Mithra Announces Presentation of Donesta® Results at the International Menopause Society’s 16th World Congress

Liège, Belgium, 8 June 2018 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today presents its Phase IIb results for Donesta® at the International Menopause Society’s 16th World Congress on menopause (Vancouver, Canada).

Donesta® is Mithra’s next-generation hormone therapy (HT) product candidate with oral administration of Estetrol (E4) for the treatment of Vasomotor Symptoms (VMS), and in particular hot flushes relief, in post-menopausal women. Mithra recently announced positive top-line results, showing a significant improvement on the frequency and severity of hot flushes, as well as on secondary menopausal symptoms such as VVA, while indicating a beneficial safety profile.

 

Information on the total number of voting rights (denominator)

Liège, Belgium, 05 June 2018 [5:45 pm CET] – Regulated information – In accordance with article 15 of the Act of 2 May 2007 on the disclosure of large shareholdings, Mithra Pharmaceuticals SA announces the following information, following the issuance of 2,672,414 new shares on 4 June 2018 in the framework of the private placement announced by press release of 30 May 2018:

Mithra Signs Binding Heads of Terms for Commercialization of Estelle® in South Korea with Women’s Health Specialist Hyundai pharm

  • Mithra eligible for milestone payments, recurring revenues and further sales-related royalty payments, with production of Estelle® for the South Korean market at the Mithra CDMO
  • With Estelle®, Hyundai Pharm aims to further expand its growing footprint in Women’s Health

Liège, Belgium, 5 June 2018 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announced that it has signed a binding Heads of Terms agreement with Hyundai Pharm, a South Korean Women’s Health leader, for an exclusive license to commercialize Estelle® in South Korea. Estelle® is Mithra’s novel combined oral contraceptive (COC) product candidate currently in pivotal Phase III trials in Europe and Russia as well as in the US and Canada, with top line results expected in Q3 2018 and Q1 2019, respectively.

Mithra Successfully Raises EUR 77.5 Million

Liège, Belgium, 31 May 2018, 07:00 CET Mithra Pharmaceuticals SA (the “Company” or “Mithra”), a company specialized in Women’s Health (Euronext Brussels: MITRA), announces that it has successfully raised EUR 77.5 million in gross proceeds by means of a private placement of 2,672,414 new shares through an accelerated bookbuild offering (the “Private Placement“).

Mithra Announces Further Positive Phase IIb Donesta® Efficacy and Safety Data

  • Further analysis of the E4 Relief dose-finding study shows a statistically significant reduction in the severity of VMS (hot flushes) at the optimal minimum dose (15 mg  E4)
  • Data reinforce the previously announced positive Phase IIb Donesta® results, demonstrating a meaningful and statistically significant reduction in the frequency of VMS
  • Encouraging cardiovascular safety profile further confirmed by hemostatic, glucose and  lipid markers
  • Data will be presented at the International Menopause Society Conference on 8 June 2018
Liège, Belgium, 30 May 2018, 16:06 CET – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces further positive topline data from the E4 Relief Phase II study of Donesta® for the treatment of Vasomotor Symptoms (VMS), and in particular hot flushes relief, in post-menopausal women. Donesta® is Mithra’s next-generation hormone therapy (HT) candidate with oral administration of Estetrol (E4).

Mithra Launches Capital Increase by Means of a Private Placement via an Accelerated Bookbuild Offering

Liège, Belgium, 30 May 2018, 16:05 CET – Mithra Pharmaceuticals SA (the “Company” or “Mithra”), a company specialized in Women’s Health (Euronext Brussels: MITRA), announces the launch of a capital increase of approximately EUR 60 million by means of a private placement via an accelerated bookbuild offering (the “Private Placement”), with the possibility to increase the size of the Private Placement to up to 3,880,440 new shares in total (representing up to approximately 11% of the Company’s issued share capital).

Update on Mithra and Mayne Pharma’s Vaginal Contraceptive Ring Opportunity

Liège, Belgium, 28 May 2018 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today provides an update on the progress made with its vaginal contraception ring, Myring™ for the US market.

Mithra Announces Injectable Contrat with Midas Pharma

  • Mithra closes contract with Midas Pharma for development and potential manufacturing of sterile injectable
  • Strong validation by reputable partner of know-how and capabilities of Mithra CDMO

Liège, Belgium, 16 May 2018 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces a contract with Midas Pharma for the development of a sterile injectable product at the Mithra CDMO . Midas Pharma, based in Germany, is a full-service provider and a leader in the sourcing and supplying of intermediates, APIs (Active Pharmaceutical Ingredients), FDFs (Finished Dosage Forms) and dossiers for finished products. The company is present in 10 countries and works with generic pharma players, big pharma companies as well as biotech firms.