Mithra obtains crucial additional Estelle® patent in Japan

  • Estelle®, Mithra’s oral contraceptive product candidate, has been granted a key patent for the dysmenorrhea indication in Japan, a four times larger market than the contraceptive one.
  • Important milestone for the commercialization of Estelle® by Fuji Pharma in Japan and ASEAN, representing a total attractively priced market of EUR 400 million annual sales.
  • Thanks to a solid Intellectual Property strategy, Estelle® will be protected from any generic competitor on the Japanese market until 2037 with a potential patent term extension of a maximum of 5 years.

Liege, Belgium, 08 August 2019 – 7 :30  CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that it has received an additional patent for Estelle® in Japan in the dysmenorrhea indication. Estelle® is Mithra’s combined oral contraceptive (COC) candidate, composed of 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP).

Mithra CDMO Strengthens its Management Team and Accelerates Key R&D Programs

  • Strengthening of management team with key appointments of Chief Scientific Officer and Plant Manager, to support the strategy execution of Mithra CDMO
  • Consolidation of R&D and manufacturing teams with 30% increase in highly qualified staff since the beginning of the year
  • Donesta® and PeriNesta® Phase III studies ready to begin, pending approval by authorities
  • Launch of production of Estelle® clinical validation batches for both U.S. and EU filing
  • Positive outcome of the registration procedure for Myring™, adding 15 new Market Authorizations in Europe
Liege, Belgium, 16 July 2019 – 7 :30  CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, announces it has strengthened its CDMO Management team with the appointments of Dr Graham Dixon as Chief Scientific Officer and Mr Renaat Baes as Plant Manager.

Mithra Signs LSA for Commercialization of Myring™ in Germany, the biggest market in Europe

  • Mithra grants exclusive license to Hormosan for commercialization of vaginal contraceptive ring in Germany
  • Germany is the largest European market in terms of volumes, with 3 million vaginal rings sold per year
  • Agreement follows licensing deals for Myring™ with market leaders in the U.S., Europe, Russia, Australia, Middle East, Latin and South America

Liege, Belgium, 28 May 2019 – 7 :30  CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that it has entered into an exclusive license and supply agreement with Hormosan for the commercialization of its hormonal contraceptive ring Myring™, bioequivalent to Nuvaring®, in Germany. Hormosan is a subsidiary of the innovation-driven pharmaceutical company Lupin Group, offering low-cost generics in Germany that offer added value relevant to therapy.

Tibelia®, First Tibolone-Based Hormone Therapy Approved in Canada

  • The Canadian Health authorities have granted the Marketing Authorization for Tibelia®, the company’s tibolone-based product for use in Hormone Therapy (HT).
  • First tibolone-based hormone treatment to be available in Canada, offering a true new option for women with a proven efficacy, tolerability and safety profile
  • The introduction of Tibelia® in Canada plays a crucial role in the international commercial expansion strategy in key attractive markets like the United States

Liege, Belgium, 15 May 2019 – 7 :30  CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that Health Canada, the Canadian Health authorities, has approved Tibelia® (tibolone), indicated for the short-term treatment of vasomotor symptoms due to estrogen deficiency in postmenopausal women, more than one year after menopause. Developed by Mithra as bioequivalent version of Livial®, Tibelia® is a synthetic steroid that relieves postmenopausal symptoms and prevents osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products.

 

Information on the Total Number of Voting Rights (Denominator)

Liege, Belgium, 29 April 2019 – 17:45 CEST – In accordance with article 15 of the Law of 2 May 2007 on the disclosure of large shareholdings, Mithra Pharmaceuticals SA announces the following information, following the issuance of 24,750 new shares on 24 April 2019 for an amount of EUR 84,690 as the result of the exercise of 15 subscription rights (warrants) pursuant to the warrant plan initiated on 2 March 2015.

Following this capital increase, Mithra now has 37,688,995 outstanding shares carrying voting rights (37,664,245 outstanding shares previously).

Therefore, Mithra publishes the updated following information :

  • Share capital: EUR 27,591,999.58
  • Total number of securities carrying voting rights: 37,668,995 (all ordinary shares)
  • Total number of voting rights (= denominator): 37,668,995 (all relating to ordinary shares)
  • Number of rights to subscribe securities carrying voting rights not yet issued:
    • Pursuant to the warrant plan of 2 March 2015: 620 warrants giving right to 1,023,000 shares
    • Pursuant to the warrant plan of 5 November 2018 and following the offer of new subscription rights for new members of the Management Team: 1,336,034 warrants giving right to 1,336,034 shares

Mithra Signs License and Supply Agreement for Commercialization of Myring™ in Latin and South America

  • Mithra grants exclusive 10-year license to Megalabs for commercialization of vaginal contraceptive ring in Argentina, Paraguay and the Dominican Republic
  • Product to be manufactured at Mithra CDMO facility in Belgium
  • Agreement follows licensing deals for Myring™ with international market leaders in the U.S., Europe, Russia, Australia, Middle East and Chile
Liege, Belgium, 25 April 2019 – 7:30  CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that it has entered into an exclusive license and supply agreement with the pharmaceutical group Megalabs for the commercialization of its vaginal contraceptive ring Myring™ in Latin America and South America. Based in Uruguay, Megalabs develops a wide range of market-leading pharmaceutical products in twenty Latin American countries.

Mithra announces new agreement with GSP for development of an additional injectable

  • Agreement with Generic Specialty Pharma (GSP), a leading generics player, for development and supply of a fifth hormonal injectable.
  • Expansion of Mithra CDMO’s portfolio of activities, confirming its profile as a unique industrial partner in the development and production of a complete range of specialized medical products and devices.

Liege, Belgium, 18 April 2019 – 7:30 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that it has entered into a new agreement with Generic Speciality Pharma (GSP) for the development and supply of a sterile hormonal injectable product at Mithra CDMO. Headquartered in Dublin, GSP is part of the Alter Pharma group, a Belgian pharmaceutical conglomerate focused on the development and manufacturing of niche generics, complex generics and high added value products.

Mithra Releases 2018 Annual Report and Invitation to its General Shareholders’ Meeting

Liege, Belgium, 8 April 2019 – 7:30  CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces the publication of its 2018 Annual Report and the invitation to its Ordinary and Extraordinary General Shareholders’ meeting.

Annual Report
The Annual Report which outlines Mithra’s achievements in 2018 includes the following information:

  • Overview of Mithra’s R&D pipeline and Letter to Shareholders;
  • Highlights of Mithra’s Strategy and Outlook for 2018;
  • Management Report;
  • Remuneration Report;
  • Financial statements and notes.

The Annual Report is available in English and French and can be downloaded on the website investors.mithra.com. In case of interpretation differences, the French version will prevail.

François Fornieri, CEO Mithra Women’s Health, commented : « 2018 has been another record year for Mithra. Our key clinical programs have successfully completed significant milestones, bringing our three potential blockbusters closer to the market. The positive top-line results of the Estelle® Phase III study in both Europe/Russia and the U.S./Canada confirmed the novel efficacy and safety profile and great potential of Estelle®, a true 5th generation oral contraceptive. Our novel candidate for menopausal symptoms, Donesta®, has also successfully completed Phase II of its clinical development. Mithra has also entered a major new and untapped commercial market, perimenopause, with a third potential blockbuster PeriNesta™. Mithra also continued to strengthen its IP portfolio for E4 in contraception and menopause with additional formulation patents filed, bringing the total number of patent families to thirty.

In 2019, we will continue to advance our business development efforts across our blockbuster E4 candidates, as well as our complex therapeutics, boosting revenues and underscoring the Group’s financial strength in both the short- and medium term. We expect to announce a commercial partner for Estelle® in the United States, our biggest market.  We intent to file with regulatory agencies by the end of 2019 . Donesta® will begin its Phase III study in the second half of 2019.  At the same time, we plan to begin the Phase III study of PeriNesta™, requiring limited extra investment. Additional indications for Estetrol (E4) for neuroprotection and wound healing are also under development in the pre-clinical phase.

2019 marks the 20th anniversary of Mithra and has already started in the most beautiful way. We had the great honour to receive the prestigious essenscia Innovation Award 2019 from Her Royal Highness Princess Astrid. This award tops off the hard work, perseverance and passion of an entire team for nearly 20 years. We eagerly await the exciting year ahead, and in the meantime, thank all of our stakeholders, patients, business partners and employees, for their continued trust in Mithra. »


Ordinary General Shareholders’ meeting

Mithra is pleased to invite its shareholders to its Ordinary and Extraordinary General Shareholder’s meeting that will be held on May 16 2019 at 2:00 PM (CEST) in Mithra CDMO, Rue de l’Expansion 57 in Flémalle (Belgium).

The notice for the General Shareholder’s meeting including a description of the formalities to participate in the Meeting is available on the website investors.mithra.com.

 

 

Mithra wins essenscia Innovation Award 2019 for its new generation contraceptive pill, Estelle®

  • Mithra wins the Essenscia Innovation Award, the most prestigious prize for industrial innovation in Belgium
  • Jury of experts recognize the major breakthrough and worldwide potential of this new generation contraceptive pill
  • Capping more than 20 years of research and development, this award was presented by her Royal Highness, the Princess Astrid, during a ceremony at the Palace of the Academies in Brussels

Liege, Belgium, 02 April 2019 – 17:00 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that it won the prestigious essenscia Innovation Award 2019. Awarded every two years by the Federation of Chemistry and Life Sciences, the Innovation Award is the most important prize for industrial innovation in Belgium. It aims to highlight the greatest innovations of Belgian industry and to encourage Belgian companies to continue to invest in innovative and sustainable products.

Mithra receives Orphan Drug Designation from FDA for E4 in neonatal encephalopathy treatment

  • The US Food and Drug Administration granted E4 an ODD for the treatment of life-threatening hypoxic ischemic encephalopathy (HIE)
  • This new designation expands E4’s broad potential in therapeutic areas beyond the leading indications in women’s health
  • Mithra continues its preclinical studies in HIE, a severe pediatric syndrome that affects 30,000 newborns each year in Europe and the United States

Liege, Belgium, 2 April 2019 – 7 :30  CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that it has received Orphan Drug Designation (ODD) from the Food and Drug Administration (FDA) for the use of E4 in Neonatal Encephalopathy (NE). In addition to its three late-stage E4-based product candidates for contraception, perimenopause and menopause, Mithra is developing E4’s potential in other therapeutic areas, particularly in neuroprotection for the treatment of hypoxic ischemic encephalopathy (HIE), a life-threatening form of neonatal asphyxia.