Mithra Plans to Submit Myring for US and EU Approval in Q2 2017

Planned submissions follow successful trials demonstrating bioequivalence to NuvaRing®

Liège, Belgium, 24 January 2017 – Mithra Pharmaceuticals (Euronext Brussels: MITRA), a company focused on women’s health, today announces that it intends to submit its combined hormonal contraceptive vaginal ring, Myring, for marketing approval in both Europe and the United States in Q2 2017.

Mithra Launches its Product Tibelia on the Global Market

  • Mithra Pharmaceuticals received 14 Marketing Authorizations (MA) in 12 European countries for its product based on tibolone.
  • Mithra should receive shortly 3 more authorizations for France, Italy and Greece.
  • Tibelia received 24 months shelf-life and should be able to extend this one in 36 months in 2017, what would give the product a unique advantage on the market and would make it more competitive than its competitors.
  • In 2016, Mithra signed 8 License and Supply Agreements.
  • Mithra expects to sign other agreements with Ukraine, Russia, Chile, Singapore, France and Switzerland.
  • Mithra estimates, according to the sales forecasts of his distributors, incomes in double digit for the next five years.

Liège, Belgium, 22 December 2016 – Mithra Pharmaceuticals, a company focused on Women’s Health, announces today that it obtained 14 Marketing Authorizations for the commercialization of its product Tibelia in the United Kingdom, Belgium, Holland, Luxembourg, Spain, Portugal, Germany, Hungary, Poland, Norway, Sweden and Finland. Mithra is still waiting for 3 MA in France, Greece and Italy that should be received by the beginning of 2017.

The product based on tibolone developed by Mithra will be more competitive due to its extended shelf-life.

Valérie Gordenne, CSO Mithra Pharmaceuticals: “At this stage, we believe we can justify a shelf-life of 36 months versus 24 months for the competitors. Currently, data are available on 24 months for the pilot batches. Trends show a possible stability extension. The results are confirmed on the first industrial batch (18 months). The best stability of the active ingredient in the formulation is linked to specific components of this formulation, for which a patent has been applied.”

In 2016, Mithra signed 8 License and Supply Agreements in the United Kingdom, Spain, Switzerland, Germany, Benelux, Australia, South Africa, Canada and Finland for a total amount in double digit, down payments included. In 2017, Mithra expects to sign other agreements with Ukraine, Russia, Chile, Singapore and France.

In United Kingdom, marketing is already effective, as well as it will be effective in Spain and Holland in January 2017.

François Fornieri CEO Mithra Pharmaceuticals: “Obtaining a Marketing Authorization for a product candidate is a real recognition of the unique expertise of our team in terms of development and regulatory affairs. Tibelia is set to be a competitor on the European market. It is indeed a ‘complex’ therapeutical solution as tibolone, the active ingredient involved, is known as a particularly unstable active ingredient, presenting many challenges in terms of development. Obtaining marketing authorisations for such a product is a significant validation for Mithra’s development and regulatory expertise, which was previously demonstrated in the development of Mithra’s first R&D projects developed in the past, and which will continue to serve it well as it continues to develop and prepare the regulatory pathway for its lead products based on Estetrol.”

The global market of tibolone is an attractive and growing market of EUR 131 million , accounting for an increase of 4.3% in value . In terms of volume, this market represents 315 million tablets, up 2% .

About Tibelia

Tibelia is a synthetic steroid (tibolone) intended to be used for hormone replacement therapy. Tibelia is a product that mimics the activity of the female sex hormones in the body, and is used especially for the relief of symptoms occurring after menopause. In some countries, this product is also used for the prevention of osteoporosis. It has been demonstrated that tibolone has favourable effects on various tissues in the body, such as brain, vagina and bone .

 

Success for Myring European Clinical Trial

  • Myring demonstrates bioequivalence to European version of NuvaRing®
  • Mithra preparing to file for regulatory approval in Europe and the U.S. in Q2 2017

Liège, Belgium, 8 December 2016 – Mithra Pharmaceuticals (Euronext Brussels: MITRA), a company focused on women’s health, today announces the results of the first of two bioequivalence studies, which demonstrate that its combined hormonal contraceptive vaginal ring, Myring, is bioequivalent to the branded European version of NuvaRing®.

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Mithra Obtains a Marketing Authorisation for its Own Product Tibelia® in Spain for Which it has Two Commercial Agreements

Liège, Belgium 5 July 2016 – Mithra Pharmaceuticals announces today that it obtained a new Marketing Authorisation for the commercialization of its product Tibelia® (bioequivalent of Livial® developed by Mithra) in Spain.

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Mithra Signs a License and Supply Agreement with Gedeon Richter for its product Tibelia® in 6 European Territories

Liège, Belgium 28 June 2016 – Mithra announces that it signed a non-exclusive License and Supply Agreement with the Hungarian company Gedeon Richter for its product Tibelia®. Under the terms of this contract, Mithra grants Gedeon a non-exclusive license for the commercialization of Tibelia® in Italy, Switzerland, Spain, Germany, Belgium and Luxembourg.

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Mithra Launches Manufacturing of Myring First Technical and Clinical Batches

Liège, Belgium 10 May 2016 –  Mithra announces that the production of the first technical and clinical batches of Myring, a combined hormonal contraceptive vaginal ring made of ethylene vinyl acetate copolymers (EVA), has started within its external CMO (Macors). These clinical batches will be used in the bioequivalence study.

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Mithra’s Tibelia® gets green light for market authorization in 14 European Countries, reinforces its CDMO ​production pipeline and demonstrates its development capabilities

·  After Xena® and Levosert®, Tibelia® becomes the third R&D project in which Mithra has been involved from research phase to approval from regulatory authorities, underlining the strength and expertise of its development and regulatory teams in tackling complex generic developments.

·  This step allows Mithra to enter the worldwide tibolone market, a growing market of 131 Million euro, and means that Tibelia® looks set to provide Mithra with a source of near-term cash flow in terms of license payments and sales revenue

·  Additionally, this approval reinforces the pipeline of products that Mithra can produce in-house at its CDMO in Flémalle. 

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Mithra Acquires 100% Rights of Myring and Zoreline® and Closes first Distribution Deal

• Mithra buys 50% of Novalon SA
• Mithra (Novalon) buys back rights relating to Zoreline® and Myring (therapeutic equivalent products of branded products having realized, in 2014, worldwide sales in excess of 1.6 billion EUR) from GSP
• Mithra (Novalon) concludes its first commercialisation partnership for Zoreline® for selected countries

Liège, Belgium, 08 December 2015 – REGULATED INFORMATION- Mithra and GSP are pleased to announce that they have entered into a number of transactions by which Mithra has acquired the complete ownership of Novalon SA, the company which develops the projects Zoreline® and Myring, which are therapeutic equivalents to branded products which, in 2014, realized aggregate worldwide sales in excess of 1.6 billion EUR, as well as the global rights to these products. In parallel, they have entered into the first distribution deal for selected countries in respect of Zoreline®.

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Mithra Pharmaceuticals SA/NV Announces the Last Patient Enrollment in the Pharmacodynamics & Pharmacokinetics Studies of the Zoreline® Implant 10.8 mg

Liège, Belgium 18 November 2015 – Regulated information:  Mithra Pharmaceuticals, leader in Women’s Health and cutting-edge technological company in the field of API slow-release drugs based on polymere (subcutaneous implants, biocompatible rings, hormonal IUD’s), announced today that it has enrolled the last patient required in the pharmacodynamics & pharmacokinetics studies of its Zoreline® subcutaneous implant 10.8 mg.

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