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Mithra in 2017

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  1. forum rang 4 FatCool 14 januari 2017 17:44
    Met een emissiekoers van €12,00 in juni 2015, een slotkoers van €10,20 in december 2015 en een slotkoers van €9,04 in december 2016 heeft Mithra het sinds de emissie niet goed gedaan voor beleggers.

    Operationeel gaat het wel goed. Met een fase II voor Donesta en fase III studies voor Estelle in Europa en Noord-Amerika. Als die studies goed uitpakken, kan de koers enorm omhoog.

    Fingers crossed!!

    fc
  2. forum rang 4 FatCool 14 januari 2017 17:49
    MITHRA’S NORTH AMERICAN ADVISORY BOARD FOR DONESTA® WILL MEET IN MIAMI, FLORIDA 20TH - 21ST JANUARY 2017

    Mithra has set up scientific advisory boards composed of international experts to support the development of Donesta®, its product candidate for menopause based on Estetrol (E4).

    The North American scientific advisory board, set up by Mithra, is aiming
    at gathering additional development guidance from international experts in the menopause field.

    Liège, Belgium, 12 January 2017 – In order to support the development programme and to prepare its product candidate for a future introduction on the market, Mithra has set up a North American advisory committee. Composed of 7 acknowledged menopause experts from the USA and Canada, this committee will especially advise Mithra on the clinical relevance and the potential added value of E4 based product candidate for the treatment of vasomotor symptoms. The committee will work with Mithra to challenge the current and future development plan with the needs of the community at large. This meeting will be chaired by Prof. Jean-Michel Foidart, member of Mithra’s scientific committee.

    François Fornieri, CEO of Mithra Pharmaceuticals: “We are extremely proud that we have been able to bring top tier opinion leaders together to help us with our development plan which is a key objective for Mithra. The interest these international experts show in taking part in this meeting reflects the continuous and growing need for safe and effective solutions in the menopause field. We expect our product candidate will bring more choices to women and hope it will allow to address the unmet medical needs they are confronted with”.

    A second Pan-European advisory board meeting will be organized in Lisboa, Portugal in February 2017 to pursue this world market analysis and support the development plans in the EU.
  3. forum rang 4 FatCool 31 januari 2017 09:06
    MITHRA STRENGTHENS POSITION IN THE BELGIAN CONTRACEPTION MARKET

    Mithra builds on leading position in Belgian contraceptive market
    Mithra achieves significant increase in 2016 sales
    Market trend validates Mithra’s Estetrol-based programs

    Liège, Belgium January 31, 2017 - Mithra Pharmaceuticals (Euronext Brussels: MITRA), a company focused on women’s health, today announces that it increased its market share in Belgium by 0.97% to 45.84% compared to 2015, placing it ahead of Bayer and Merck.

    The Company also achieved an increase in sales of 4.23%. The Belgian
    contraception market grew by 2.01 % during 2016 or 229.389 cycles.
    In 2016, there were 17.645 more women using a contraceptive product, of these Mithra has captured 16.659 of the new patients, representing 94.4 % of the total growth of the market in 2016.

    Mithra remains largely in poleposition in terms of sold cycles with a significant growth of 4.23 % or +216.576 cyles. In 2016, over 410.500 women(almost 1 in every 2 women who takes an oral contraceptive) use
    a Mithra oral contraceptive product in Belgium.

    François Fornieri, CEO of Mithra Pharmaceuticals: "This leading position strengthens the credibility of Mithra on its own market, but also internationally, which is positive for our Estetrol-based R&D project
    in contraception which would present a lower VTE risk and an improved safety profile over currently available products."
  4. forum rang 4 FatCool 7 februari 2017 09:01
    MITHRA COMPLETES REC RUITMENT FOR EUROPEAN PHASE III ESTELLE® STUDY

    Liège, Belgium, 07 February 2017 – Mithra Pharmaceuticals (Euronext Brussels: MITRA), a company focused on women’s health, today announces that it has completed recruitment into the Phase III study of its product candidate Estelle®, a combined oral contraceptive based on Estetrol (E4) and Drospirenone (DRSP), in Europe and Russia.

    As of 6 February 2017, 1709 patients have been screened, of which it is expected that at least 1550 will qualify for enrollment in to the study which is designed to assess the safety and efficacy of Estelle® over the course of 12 months. Results of the European study are expected in H2 2018. A second Phase III study in the US and Canada started enrollment in September 2016.

    Francois Fornieri, CEO of Mithra Pharmaceuticals, said: “We are pleased to confirm the completion of patient enrollment into one of two pivotal studies for Estelle®. Initial studies have shown the potential advantages of Estetrol including a reduction in side effects such as the risk of venous Thromboembolism, an increase in body weight and undesired bleeding whilst on the pill. We are on track to complete the trial in 2018 and hope to be able to provide women globally with a novel contraceptive option with a better safety and efficacy profile compared to currently-available treatments.”

    European Phase III study design (Estelle®)
    The European Phase III Estelle® study design is an open-label single arm study that is expected to enroll at least 1550 patients aged 18-50 years of whom 1350 patients are aged 18-35 years. The objectives of the study are to evaluate the contraceptive’s efficacy, cycle control, and the general safety and acceptability of the 15mg estetrol (E4) and 3mg RSP combination oral contraceptive pill in healthy women aged 18-50 years old. The study is taking place in approximately 69 centres across Europe and Russia, and will involve patient enrollment for a period of 12 months (13 cycles, 1 cycle = 28 days). The primary outcome measures will be the number of pregnancies per 100 women per 12 months of exposure in patients aged 18 to 35 years old. The secondary outcomes will measure the on-treatment pregnancies within the overall study population (18-50 years), bleeding profile, safety and tolerability, general wellbeing of the patients (measured by two questionnaires) and any adverse impact on the endometrium. This last parameter will be evaluated based on 167 patients out of the expected 1550 enrolled.
  5. forum rang 4 FatCool 8 februari 2017 19:50
    Mijn positie op €9,89 bijna verdubbeld vandaag. Zo slecht was het nieuws toch niet gisteren. Er is duidelijk wat verkoopdruk de laatste dagen. Er lag een blok van ongeveer 20000 aandelen rond de €9,90 vandaag, die de koers fixeerde. Benieuwd of het aanbod nu weg is en of we weer wat omhoog kunnen!?

    fc
  6. BelgFre 15 februari 2017 22:06
    quote:

    FatCool schreef op 15 februari 2017 22:04:


    De Donesta phase II komt er eerdaags aan, was gepland voor eind 2016 dus is al ietwat vertraagd.

    Daarnaast verwacht ik voor het eind van de maand februari een deal over Estelle met het Chinese bedrijf.

    Kortom, een paar belangrijke pers momenten.

    fc

    idd, las ook ergens dat die Donesta nadert

    worden spannende dagen maw... :)
  7. BelgFre 28 februari 2017 11:57
    Feb 28 (Reuters) - Mithra Pharmaceuticals SA MITRA.BR :
    * Mithra concludes exclusive license and supply agreement with Mayne Pharma for
    myring marketing in the United States
    * Under the terms of the agreement, Mayne Pharma will pay milestones of at least 10 million
    euros ($10.59 million) following approval by US (FDA)
    * Mithra will produce Myring for Mayne Pharma in its Research, Development and Production
    Center (Mithra CDMO)
    * Under the terms of the agreement, Mithra will receive 2.4 million euros upon signing

    Source text for Eikon:
    Further company coverage:

    ($1 = 0.9446 euros)

    (Gdynia Newsroom)
    ((gdynia.newsroom@thomsonreuters.com; +48 58 772 09 20;))

    leuk toch?
    mag doorsijpelen naar de beurs....
  8. R dayhigh 28 februari 2017 12:05

    Mithra Pharmaceuticals: AGREES EXCLUSIVE LONG-TERM LICENSE AND SUPPLY AGREEMENT WITH MAYNE PHARMA TO COMMERCIALIZE MYRING(TM) IN THE US





    28 februari 2017 07:00



    PRESS RELEASE



    Mithra agrees ExclusiveLONG-TERMlicense and supply agreement with Mayne Pharma to commercialize Myring(TM) in the US


    ?
    Mithra grants its first exclusive license for its vaginal contraception ring, Myring(TM), to Mayne Pharma (ASX: MYX), the second-largestsupplierof oral contraceptives in the USmarket, covering commercialization in the United States

    ?
    As part of the agreement, Mayne Pharma will pay milestones of at least EUR 10.0m following approval by the US FDA

    ?
    Mithra will produce Myring(TM) for MaynePharmaat its Research, Development and Manufacturing facility (Mithra CDMO)




    Liège, Belgium, 27 February 2017- Mithra Pharmaceuticals, a company dedicated to Women's Health, is pleased to announce an exclusive long-term license and supply agreement that extends beyond 10 years with Mayne Pharma, a leading specialty pharmaceutical company, for the commercialization in the United States of Myring(TM), Mithra's combined hormonal contraceptive vaginal ring made of ethylene vinyl acetate copolymers (EVA). Mayne Pharma is the second largest supplier of oral contraceptive products in the US market.

    Under the terms of the agreement, Mithra will receive EUR 2.4m upon signature, as well as significant milestone payments on ANDA approval (market approval by the FDA) and on the commercial launch of the product. As a part of Mayne Pharma's long-term exclusive sourcing commitment, Mithra is considering the expansion of its production capacity for Myring(TM).

    Currently, the US market for biocompatible contraceptive rings is worth EUR 740m [1] , which represents approximately 30% of the total global market by volume and over 75% by value, making this a key territory for the commercialization of Myring(TM).

    Mithra is anticipating important financial contributions from this product post-commercial launch, aligned with the market potential and Mayne Pharma's commitment to the oral contraceptive market.

    François Fornieri, CEO Mithra Pharmaceuticals:"This agreement with Mayne Pharma further demonstrates Mithra's attractiveness for partnerships, exemplifying our strategy to seek specialist partners around the world. It also underlines our expertise in polymers and proves the confidence that key US companies have in our know-how and the research and manufacturing capabilities of Mithra's CDMO. Furthermore, the attractive deal terms validate Mithra's acquisition of the remainder of Novalon in December 2015. Through the acquisition of a portfolio of 42 pharmaceutical products from Teva last year, Mayne Pharma became a top 25 retail generic pharmaceutical company with an extensive portfolio of women's health products. Hence, we strongly believe that we have the best partner at our side to market our vaginal ring, Myring (TM) , in the key US market."

    About Mayne Pharma

    Mayne Pharma is a publicly traded specialty pharmaceutical company listed on the Australian Securities Exchange (ASX: MYX). The company develops and manufactures branded and generic products globally - either directly or through distribution partners - while applying its drug-delivery expertise for contract development and manufacturing services. Mayne Pharma has a 30-year track record of innovation and success in developing new oral drug delivery systems, and its technologies have been successfully commercialized in products marketed around the world. Mayne Pharma has drug development and manufacturing facilities in Greenville, North Carolina, USA, and Salisbury, Australia, and offers expertise in formulating complex oral dose forms including highly potent compounds, controlled substances, and modified release products. In the United States, Mayne Pharma's operations consist of U.S. Generic Products, U.S. Specialty Brands, and Metrics Contract Services.

    About Myring(TM)

    Myring(TM) is developed to be a generic of Nuvaring® vaginal ring, still under patent protection up to April 2018 both in the US and in EU. Myring(TM) (etonogestrel/ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent, combination contraceptive vaginal ring, with an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. It is made of ethylene vinylacetate copolymers, and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. When placed in the vagina, each ring releases, in line with the originator (Nuvaring®), on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. The ring is to remain in place continuously for three weeks. It is removed for a one-week break, during which a withdrawal bleed usually occurs. A new ring is inserted one week after the last ring was removed.
  9. forum rang 4 FatCool 2 maart 2017 01:17
    Vanavond een positief persbericht over Donesta.

    Mithra Signs a Binding Term Sheet with the Japanese Leader in Women’s Health Fuji Pharma to Commercialize Donesta® in Japan and ASEAN.

    Door een uitbreiding van de phase II study is er een vertraging van deze studie tot eind Q1 2018. Maar uit het persbericht lees ik een uiterst positieve ontwikkeling van Donesta.

    fc
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