Mithra Applies for Additional Estelle® Patent Based on Positive Hemostasis Data

  • Patent will strengthen and extend the existing Estelle® and E4 intellectual property estate
  • Positive hemostasis data differentiate Estelle® from commonly prescribed combined oral contraceptives

Liège, Belgium, 28 March 2018 – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that it has filed an additional patent application in Europe based on the data generated in the Estelle® hemostasis Phase II substudy. Estelle® is Mithra’s combined oral contraceptive (COC) candidate, composed of 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP), and is currently being tested in two Phase III trials in Europe/Russia and in the US/Canada.

Mithra Announces Completion of Estelle® Cycles Required in Phase III Contraception Studies

  • Estelle® Phase III studies remain on track to report top-line results in Q3 2018 from Europe/Russia and Q1 2019 from US/Canada

Liège, 23 march 2018 – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that the minimum number of female cycles required by regulators in both of the pivotal Phase III Estelle® studies have now been successfully completed. Estelle® is Mithra’s combined oral contraceptive (COC) candidate, composed of 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP), and is currently being tested in two Phase III trials in Europe/Russia and in the US/Canada.

Mithra and Mayne Pharma’s Vaginal Contraceptive Ring Accepted for Filing by FDA

  • Filing acceptance is a key regulatory milestone, confirming time line towards potential launch in the US by Mayne Pharma in H1 201
  • Pending FDA approval, Mithra is eligible for down payment and milestone payments totaling at least EUR 10 million
  • Mithra to produce Myring™ for Mayne Pharma at its CDMO, with substantial annual revenues expected

Liège, Belgium, 20 March 2018 – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, is pleased to announce that the Abbreviated New Drug Application (ANDA) for its vaginal ring for contraception has been accepted for filing by the US Food and Drug Administration (FDA). The ANDA has been submitted by Mithra’s partner for the US commercialization of the vaginal ring, Mayne Pharma (ASX: MYX). The acceptance by the FDA is an important regulatory step, as it reconfirms the pathway towards launch of the product candidate in H1 2019.

Mithra and Alvogen Sign LSA for Vaginal Contraception Ring in Russia

  • Mithra grants exclusive license for vaginal contraception ring to Alvogen for commercialization in Russia
  • Agreement follows MyringTM licenses[1] closed with Mayne Pharma, Gynial and Adamed for the US, Austria and the Czech Republic, respectively
  • Vaginal ring shall be manufactured at Mithra CDMO

Liège, Belgium, 16 March 2018, 05:45 PM – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announced an exclusive license and supply agreement (LSA) with Alvogen for the commercialization in Russia of Mithra’s contraceptive vaginal ring product candidate made of ethylene vinyl acetate copolymers (EVA). Financial details of the agreement were not disclosed.

Mithra Presents Positive Hemostasis Results at ISGE Conference

  • Analysis across a range of parameters points to limited hemostatic impact for Estelle®, at least comparable to EE/LNG (Melleva®) and much lower than benchmark EE/DRSP (Yaz®)
  • Results corroborate earlier findings and further delineate unique safety profile of Estelle®

Liège, Belgium, March 08, 2018 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today presents more details of its Phase II hemostasis study of Estelle®, Mithra’s combined oral contraceptive (COC) candidate based on 15 mg E4 (Estetrol) and 3 mg DRSP (drospirenone). The data were presented at the occasion of the Gynaecological Endocrinology Conference (ISGE) in Florence.

Mithra Reports 2017 Annual Results

  • Significant operational progress for highly promising E4 (Estetrol)-based pipeline, including 5th generation oral contraceptive Estelle® and next-generation menopause therapy Donesta®
  • Important commercialization partnerships established with leaders in Women’s Health, including Libbs for Estelle® in Brazil, Fuji Pharma for Donesta® in Japan & ASEAN and Mayne Pharma for Myring™ in the US
  • Strong revenue increase and improved EBIT thanks to accelerating business development activity and solid Benelux operations

Liège, Belgium, 2 March 2018 – 7:30 AM : Mithra Pharmaceuticals (Euronext Brussels: MITRA), a company focused on Women’s Health, today announces its results for the year ended 31 December 2017, prepared in accordance with IFRS.