Saturday 31 December 2016

Mithra Pharmaceuticals: MITHRA LAUNCHES ITS PRODUCT TIBELIA ON THE GLOBAL MARKET

Mithra dispatches ITS item Tibelia[1] on the GLOBAL market

Mithra Pharmaceuticals got 14 Marketing Authorizations (MA) in 12 European nations for its item in view of tibolone.

Mithra ought to get in no time 3 more approvals for France, Italy and Greece.

Tibelia got 24 months' timeframe of realistic usability and ought to have the capacity to extend this to 36 months in 2017, what might give the item a remarkable preferred standpoint available and would make it more aggressive than its rivals.

In 2016, Mithra marked 8 License and Supply Agreements.

Mithra hopes to consent to different arrangements with Ukraine, Russia, Chile, Singapore, France and Switzerland.

Mithra gauges, as indicated by the business conjectures of his merchants, earnings in twofold digit for the following five years.

Liège, Belgium, 22 December 2016 - Mithra Pharmaceuticals, an organization concentrated on Women's Health, reports today that it got 14 Marketing Authorizations for the commercialization of its item Tibelia in the United Kingdom, Belgium, Holland, Luxembourg, Spain, Portugal, Germany, Hungary, Poland, Norway, Sweden and Finland. Mithra is as yet sitting tight for 3 MA in France, Greece and Italy that ought to be gotten by the start of 2017.

The item in light of tibolone created by Mithra will be more focused because of its augmented time span of usability.

Valérie Gordenne, CSO Mithra Pharmaceuticals: "At this stage, we trust we can legitimize a time span of usability of 36 months versus 24 months for the contenders. Right now, information are accessible on 24 months for the pilot groups. Patterns demonstrate a conceivable security augmentation. The outcomes are affirmed on the primary mechanical bunch (year and a half). The best steadiness of the dynamic fixing in the definition is connected to particular segments of this plan, for which a patent has been connected."

In 2016, Mithra marked 8 License and Supply Agreements in the United Kingdom, Spain, Switzerland, Germany, Benelux, Australia, South Africa, Canada and Finland for an aggregate sum in twofold digit, up front installments included. In 2017, Mithra hopes to consent to different arrangements with Ukraine, Russia, Chile, Singapore and France

In United Kingdom, advertising is as of now successful, and also it will be viable in Spain and Holland in January 2017.

François Fornieri CEO Mithra Pharmaceuticals: "Getting a Marketing Authorization for an item competitor is a genuine acknowledgment of the novel skill of our group as far as advancement and administrative issues. Tibelia is set to be a contender on the European market. It is without a doubt a "complex" helpful arrangement as tibolone, the dynamic fixing included, is known as an especially precarious dynamic fixing, introducing many difficulties as far as improvement. Acquiring advertising authorisations for such an item is a critical approval for Mithra's improvement and administrative aptitude, which was beforehand shown in the advancement of Mithra's first R&D ventures created previously, and which will keep on serving it well as it keeps on creating and set up the administrative pathway for its lead items in view of Estetrol."

The worldwide market of tibolone is an alluring and developing business sector of EUR 131 million[2], representing an expansion of 4.3% in value[3]. As far as volume, this market speaks to 315 million tablets, up 2%[4].

About Tibelia

Tibelia is a manufactured steroid (tibolone) expected to be utilized for hormone substitution treatment. Tibelia is an item that emulates the action of the female sex hormones in the body, and is utilized particularly for the alleviation of manifestations happening after menopause. In a few nations, this item is additionally utilized for the counteractive action of osteoporosis. It has been shown that tibolone effectsly affects different tissues in the body, for example, cerebrum, vagina and bone[5].

Pictures

For pictures of François Fornieri, please tap on the accompanying connection:

http://www.mithra.com/en/logo/

For more data, please contact:

Press

Julie Dessart

Boss Communication Officer

+32 4 349 28 22/+32 475 86 41 75

press@mithra.com

Speculator Relations

François Fornieri, CEO

+32 4 349 28 22

investorrelations@mithra.com

Consilium Strategic Communications

Jonathan Birt, Sue Stuart, Hendrik Thys

+44 2 037 095 700

mithra@consilium-comms.com

About Mithra

Mithra Pharmaceuticals SA, established in 1999 as a turn off of the University of Liège by Mr. François Fornieri and Prof. Dr. Jean-Michel Foidart, is an Euronext recorded pharmaceutical organization (MITRA) concentrated on Women's Health. Mithra's central goal is to enhance each phase of ladies' existence with inventive and open pharmaceutical arrangements. All things considered the Company plans to wind up distinctly an overall pioneer in ladies' wellbeing by creating, producing and commercializing exclusive, inventive and separated medications and complex remedial arrangements in four restorative fields of ladies' wellbeing: fruitfulness and contraception, menopause and osteoporosis, gynecological contaminations and female diseases.

Mithra has a rough headcount of 141 staff individuals and is headquartered in Liège, Belgium. Additional data can be found at: www.mithra.com

Critical data

The substance of this declaration incorporate articulations that are, or might be considered to be, "forward-looking explanations". These forward-looking proclamations can be recognized by the utilization of forward-looking phrasing, including the words "trusts", "gauges," "foresees", "expects", "means", "may", "will", "arranges", "keep", "progressing", "potential", "anticipate", "extend", "target", "look for" or "ought to", and incorporate articulations the Company makes concerning the proposed consequences of its technique. By their inclination, forward-looking articulations include dangers and instabilities and perusers are advised that any such forward-looking explanations are not certifications of future execution. The Company's genuine outcomes may contrast substantially from those anticipated by the forward-looking articulations. The Company embraces no commitment to freely redesign or change forward-looking articulations, aside from as might be required by law.

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