Mithra

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Re: Mithra

Berichtdoor alles kan beter » 23 Okt 2017 12:42

23/10
Mithra volgt met 1,1 procent winst tot 11,07 euro. Over het Luikse farmabedrijf, dat volgend jaar cruciale resultaten moet bekendmaken over twee potentiële blockbusters – een anticonceptiepil en een middel tegen opvliegers - is er geen concreet nieuws, maar topman François Fornieri liet zich in een interview in De Tijd wel opvallend positief uit over de twee middelen. ‘Ik geloof er steeds meer in dat het gaat lukken’, klonk het.
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Re: Mithra

Berichtdoor vogelspotter » 30 Okt 2017 08:19

Voldoende proefpersonen Noord-Amerikaanse test Mithra

Gepubliceerd op 30 okt 2017 om 08:02 |


Mithra Pharmaceuticals (27 okt)

(ABM FN) Mithra Pharmaceuticals heeft voldoende proefpersonen binnen voor zijn Fase III studie met Estelle in Amerika en Canada. Dit maakte het Waalse biotechbedrijf maandagochtend voorbeurs bekend.

Daarmee zit Mithra naar eigen zeggen op koers om in het eerste kwartaal van 2019 met resultaten te komen.

Estelle is Mithra's kandidaatmiddel voor gecombineerde orale contraceptie, dat bestaat uit 15 milligram Estetrol en 3 milligram drospirenone. De pil wordt momenteel ook getest in Europa en Rusland.
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Re: Mithra

Berichtdoor vogelspotter » 30 Okt 2017 10:24

MARKTEN LIVE
09:59


Mithra voltooit patiëntenrecrutering voor Estelle in Noord-Amerika
Het Luikse farmabedrijf Mithra meldt dat het alle patiënten heeft gerecruteerd in de VS en Canada voor zijn zogeheten E4 Freedom-studie van Estelle, de 'pil' van de vijfde generatie. 2.148 vrouwen werken aan de studie mee. De resultaten worden in het eerste kwartaal van 2019 verwacht. In Europa en Rusland loopt al een gelijkaardige studie met 1.577 vrouwen.
Bron:"DE TYD."
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Re: Mithra

Berichtdoor Lama Daila » 17 Nov 2017 07:35

Mithra Announces Positive Outcome of Myring™ Commercial Batch Bioequivalence Study
17 November 2017
Bioequivalence study performed on commercial Myring™ batch produced at Mithra CDMO
Data will form part of planned Myring™ FDA filing by US partner Mayne Pharma
Liège, Belgium, 17 November 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, announces the successful outcome of a confirmatory bioequivalence study performed on a commercial batch of Myring™ produced at the Mithra CDMO. The study results reconfirm that Myring™ is bioequivalent to Nuvaring®, a combined hormonal contraceptive vaginal ring made of ethylene vinyl acetate copolymers (EVA).
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Re: Mithra

Berichtdoor Lama Daila » 18 Nov 2017 15:16

Kbc Securities 17/11/17: BUY, target price 15,5 EUR

Myring commercial batch bioequivalent

News:
Mithra announced this morning positive outcome of the confirmatory bioequivalence study performed on the commercial batch of Myring produced at Mithra’s CDMO facility. These data essentially confirm that Mithra’s contraceptive product Myring is equivalent to Merck’s Nuvaring for which the patent will expire 2Q18. Mithra expects the EU/US Market Authorization (MA) and prepares for the subsequent launch around that time. In the US, Mayne Pharma is Mithra’s partner for commercialization and distribution. Regulatory submission of Myring to the FDA is expected in the next few months. The deal with Mayne Pharma (10y exclusive License and Service Argreement) brought an upfront of € 2.4m and Mithra is eligible to at least € 10m in milestones following the FDA approval. The US is an important market for this product, with Nuvaring sales amounting to $ 970m.
Our View:
The news of today shows that Mithra is on track to launch Myring by the time Nuvaring goes off patent. For Europe, Mithra already submitted a MAA in July 2017. The bioequivalence data, as communicated today, will complete this regulatory package and show that the CDMO facility of Mithra and its production line is ready for production by the time the regulatory approvals come in. In May 2017, this CDMO facility also got GMP (Good Manufacturing Practice) certified which is part of the necessary steps towards market launch.

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Re: Mithra

Berichtdoor Lama Daila » 18 Nov 2017 19:46

Slides van op Finance Avenue:
https://static.tijd.be/financeavenue/20 ... Mithra.pdf

70494C27-2587-4B2E-99EB-3DF0DC66C61E.jpeg
U kunt de afbeeldingen in deze bijlage niet bekijken, registreer hier en bekijk de bijlage.
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Re: Mithra

Berichtdoor Lama Daila » 22 Nov 2017 07:49

MITHRA ANNOUNCES 36-MONTH SHELF LIFE EXTENSION FOR TIBELIA®
Extended shelf-life offers competitive advantage over current tibolone-based products, including originator product Livial®  Tibelia® is currently marketed in 5 countries through existing supply and license agreements, with further contracts and product launches planned in coming months Liège, Belgium, 22 novembre 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today confirms the extended shelf-life of 36 months of its complex therapeutic product Tibelia®, as compared to 24 months for other currently available tibolone-based products. Tibelia® is a generic version of Livial® developed by Mithra. The product is a synthetic steroid (tibolone) for use in hormone replacement therapy. This includes the relief of postmenopausal symptoms, in addition to prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products. These indications represent a global market of EUR 115.8 million 1 . The 36-month shelf life extension of Tibelia® has been granted by MHRA 2 . As tibolone is a relatively unstable active ingredient, a unique formulation has been developed, for which an international patent application was filed in May 2017. The extended shelf-life offers a competitive advantage for distributors, as it allows them to optimize their supply chain management, while it may also allow patients to further space out their doctor’s visits. Tibelia® is already on the market in the UK, Spain, the Netherlands, Italy and Sweden, through existing supply and license agreements signed in 2016 and 2017. Several other launches are expected in coming months. François Fornieri, CEO of Mithra, commented: “We are pleased with the 36-month shelf-life for Tibelia®, which is a validation of Mithra’s expertise and know-how to develop Complex Therapeutics. Given the competitive advantage offered to both distributors and patients, we expect that the extended shelf-life versus other tibolone-based products will positively contribute to the revenues for Tibelia®”.

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Re: Mithra

Berichtdoor Lama Daila » 28 Nov 2017 16:37

sorry, verkeerd forum voor bericht Biocartis (ondertussen verwijderd)

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Re: Mithra

Berichtdoor Lama Daila » 30 Nov 2017 07:36

Liège, Belgium, 30 November 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces an update on the clinical study progress for its two lead Estetrol (E4) based product candidates, Estelle® (E4 Freedom) and Donesta® (E4 Relief). Estelle®, Mithra’s novel contraceptive product candidate composed of 15 mg of Estetrol (E4) and 3 mg of drospirenone (DRSP), is currently in Phase III studies in Europe/Russia and in the US/Canada. Recruitment has now been completed for both studies and currently over 50% of subjects have completed more than half of the 13 treatment cycles. Moreover, 20% have completed the full 13 cycles and the end of study visit in the European arm of the study, and over 4% of subjects in the US study. Results for the Europe/Russia and US/Canada studies are on track to report top line data in Q3 2018 and Q1 2019, respectively. Recruitment has also been completed for Donesta® which is currently in a Phase IIb dose-finding study for menopausal symptoms with E4 alone. At this stage, almost 80% of the 260 subjects have successfully finished the 12-week protocol with close to 60% of women having completed the additional end of study visit. Top-line results are expected towards the end of Q1 2018. François Fornieri, CEO of Mithra, commented: “We are pleased with the excellent progress made in our E4 clinical studies. This could be an indication of the good user acceptability of Donesta® and Estellle®, which may prove to be an important benefit for these novel product candidates. We are looking forward to the results of the studies, which have the potential to indicate that Estelle® and Donesta® offer a safer, efficient alternative to currently marketed products in contraception and menopause.”
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Re: Mithra

Berichtdoor charel01 » 30 Nov 2017 12:26

Mithra bracht een stand van zaken over E4 Donesta en Estelle, de twee belangrijkste producten van de groep die op Estetrol gebaseerd zijn. Die update bevestigde volgens KBC Securities-analist Sandra Cauwenberghs dat de groep op schema zit.

KBC Securities stelt dat 2018 voor Mithra een belangrijk jaar wordt: voor Estelle worden topline resultaten voor het onderzoek in Europa/Rusland verwacht in het derde kwartaal; voor Donesta worden resultaten verwacht aan het einde van het eerste kwartaal. De analisten schatten de piekverkopen voor Estelle op 570 miljoen euro. Voor Donesta is dat 685 miljoen euro.

KBC Securities handhaaft het advies voor de aandelen op “Kopen” met een koersdoel van 15,50 euro.
Aandelenport: Geen zaken mee. Ik meld geen aan- en verkopen meer. Men vindt het toch altijd nodig om commentaar te leveren.