Contact

  • | Complex Therapeutics

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.

Download press release

PDF version

Share it

Latest news

View all

Don't miss our news

Get the latest news: subscribe to our newsletter!

Subscribe
Go to Newsroom
Contact

Disclaimer

Please read this carefully as it applies to all persons who visit this website. The following pages contain information relating to an offering and/or admission to trading on a regulated market in relation to securities of Mithra Pharmaceuticals SA ("Mithra Pharmaceuticals"). This information may not be accessed by residents of certain countries based on applicable securities law regulations. Accordingly, if you wish to access this part of the website you must first inform yourself about and then observe the statutory and regulatory requirements applicable to you and to your jurisdiction. In order to establish whether or not you may view the information and documents please read the disclaimer below in full.

THIS WEBSITE AND THE MATERIALS CONTAINED THEREIN ARE NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, JAPAN, SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE TO DO SO WOULD BE PROHIBITED BY APPLICABLE LAW.

This website and the information contained herein or to which it gives access are not intended for, and may not be accessed by, or distributed or disseminated to, persons resident or physically present in the United States of America (including its territories, the "United States"), Australia, Japan or South Africa, and do not constitute, or form part of, an offer or invitation to sell or issue, or a solicitation of an offer or invitation to purchase or subscribe for, nor shall there be any sale or purchase of, any securities of Mithra Pharmaceuticals in the United States, Australia, Japan or South Africa or in any other jurisdiction in which such offer, invitation, solicitation, sale, issue, purchase or subscription would be unlawful prior to registration, unless an exemption from registration or qualification under the securities laws of any such jurisdiction is applicable. The securities of Mithra Pharmaceuticals referred to on this website have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), and may not be offered or sold in the United States absent registration with the United States Securities and Exchange Commission or an exemption from registration under the U.S. Securities Act. There will be no public offering of Mithra Pharmaceuticals' securities in the United States.

All persons residing outside of the United States, Australia, Canada, Japan and South Africa who wish to access the documents contained on this website should first ensure that they are not subject to local laws or regulations that prohibit or restrict their right to access this website, or require registration or approval for any acquisition of securities by them. Mithra Pharmaceuticals assumes no responsibility if there is a violation of applicable law and regulations by any person.

No action has been taken by Mithra Pharmaceuticals that would permit an offer of Mithra's securities or the possession or distribution of the materials to which this website gives access or any other offering or publicity material relating to Mithra's securities in any jurisdiction where action for that purpose is required.

Mithra Pharmaceuticals has not authorised any public offering in any Member State of the European Economic Area. With respect to any Member State of the European Economic Area that has implemented Regulation 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC, as amended from time to time (together with any applicable implementing measures in such Member State, the "Prospectus Regulation"), this website and the information contained herein, or to which it gives access, is only addressed to, and is only directed at, qualified investors in that Member State within the meaning of the Prospectus Regulation.

In addition, in the United Kingdom, this website and the information contained herein, or to which it gives access, is addressed to, and directed only at: (a) persons who have professional experience in matters relating to investments falling within article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order"), and (b) high net worth entities, and other persons to whom they may otherwise lawfully be communicated, falling within article 49(2) of the Order (all such persons together being referred to as "Relevant Persons"). In the United Kingdom, any investment or investment activity to which this website and the information contained herein, or to which it gives access, relates, is available only to Relevant Persons and will be engaged in only with Relevant Persons. Any person in the United Kingdom who is not a Relevant Person should not act or rely on this website and the information contained herein, or to which it gives access.

If you are not permitted to view materials on this website or are in any doubt as to whether you are permitted to view these materials, please exit this webpage. Access to electronic versions of these materials is being made available on this webpage by Mithra Pharmaceuticals in good faith and for information purposes only.

By checking the acceptance box below, you confirm and certify that: You are not a resident of or physically present in the United States, Australia, Canada, Japan or South Africa or any other restricted jurisdiction, and that you are either: (a) a resident of, and domiciled in, a Member State of the European Economic Area and a qualified investor within the meaning of the Prospectus Regulation, (b) a resident of, and domiciled in, the United Kingdom, a qualified investor within the meaning of the Prospectus Regulation and a Relevant Person, or (c) otherwise authorised to access this information pursuant to applicable laws or regulations.

Abort