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Mithra in 2020 - Geduld is een schone zaak

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MisterBlues
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Commerciële zegetocht Myring gaat verder. Klein bier maar toch...

Mithra and Gynial Sign Commercialization Agreementfor Myring™ in Switzerland?

Mithra grants license for its vaginal contraceptive ringto Gynial for commercialization in Switzerland?Strengthening its partnership with Women’s Health specialist Gynial,already responsible for the Austrian market?Large-scaled global commercialization of Myring™ after first successful launches in Europe

Liege, Belgium,05 May 2020–7:30

CEST–Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that it has entered into a license and supply agreement(LSA)with Gynial GmbH for the commercialization of its hormonal contraceptive ring Myring™ in Switzerland. Under the terms of this agreement, Gynial will distributeMyring™ in Switzerland, where the Swiss contraceptive rings market is worth EUR 8 million per year1. Mithrawill receive an upfront payment and recurring revenues based on an agreed licensing model.Moreover, Mithra will manufacture Myring™at its Contract Development and Manufacturing Organization facility in Belgium. This LSA is the second agreement signed with Gynial, following the one entered in 2017 for the commercialization of Myring™ in Austria. Gynial is an Austrian pharmaceutical company founded in 2007 with a key focus on Women’s Health, and on contraception in particular. To date, Mithra has licensed Myring™ to industry leaders in 31 countries, including the three biggest worldwide markets(United States, Germany and Italy). After the successful launch in Czech Republic, Belgium, Luxemburg and Germany, other launches should follow in Europe where Mithra has already obtained 21 out of 23 marketing authorizations.To meet the growing demand, the Mithra CDMO has increased its production capacity to nearly two million rings in 2020. Fromthe beginning of the health crisis caused by Covid-19, Mithra has managed to maintain the production and supplyof Myring™ on track, in compliancewith all the measures requiredby the Belgian authorities while ensuring the safety of its collaborators.François Fornieri, CEO Mithra Women’s Health, commented: “We are pleased to have finalized this second agreement withGynial, an excellent partner with whom welook forward to working with to commercialize our vaginal ring in both Swiss and Austrian markets.In this first half of the year marked by the Covid-19, we have worked very hard to ensure the pursuit of our activities, both in terms of R&D, production and financial management. All discussions and negotiations with potential commercial partners are currently being actively pursued and do not seem to be impacted in any way by the health crisis. This demonstratesa strong interest in our innovative products andsolid confidence in their potential in the growing women’s health market.”

1IQVIA 2017
MisterBlues
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About Myring™Myring™ (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.
FilipVanderAa
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Beurs nog eens in goede doen. Nu ja, de beurs in het algemeen. Geen update van Mithra.
MisterBlues
0
Geachte heer VanderAa, beste Filip, Hierbij een update van Mithra.

Een gemeenschappelijk PB


Mithra and Searchlight Pharma Announce Filing of New Drug Submission for Estelle® in Canada

- Searchlight Pharma’s New Drug Submission for a novel combined oral contraceptive (COC) accepted for review by Health Canada\

- Innovative product candidate developed by Mithra containing the unique native estrogen Estetrol (E4) and drospirenone (DRSP)

- Potential commercialization in Canada under the trademark Nextstellis® expected in mid 2021

LIEGE (Belgium) and MONTREAL (Canada), 20 May 2020 – 7:30 CEST – Mithra and Searchlight Pharma announced today that Health Canada has accepted Searchlight Pharma’s New Drug Submission (“NDS”) for a novel combined oral contraceptive (COC) product.
Developed by Mithra,

the product candidate is composed of 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP). E4 is a naturally occurring estrogen that is produced by the human foetal liver during pregnancy. Following many years of research and development, Mithra can synthesise E4 at scale through a complex plant-based production process. In two phase III clinical studies conducted in 4,400 women, E4/DRSP showed positive top-line results against primary efficacy and safety endpoints and achieved positive secondary endpoints including good bleeding profile, cycle control, and tolerability.

As per the license and supply agreement signed in April 2018, Searchlight Pharma is responsible for commercializing Mithra’s product candidate in Canada under the trademark Nextstellis®. Currently, the Canadian hormonal contraceptive market is worth approximately EUR 229 million a year, with combined oral contraceptives accounting for more than 66% of the market1. If approved by Health Canada, Nextstellis® is expected to be made available to patients in the Canadian market in mid 2021.

Mark Nawacki, President & CEO of Searchlight Pharma, commented:"With this milestone, Nextstellis® moves a very tangible step forward towards commercialization in Canada. We are excited to now concentrate our focus on planning the introduction of Nextstellis® to the Canadian market.”

François Fornieri, CEO of Mithra, said: “We are very pleased with Searchlight Pharma’s regulatory filing in Canada. After the United States and Europe, this is the third major global market to achieve its regulatory filing, putting us on track for a potential marketing authorization in mid 2021 in Canada. We continue to believe that our product candidate has the potential to become a true ‘next generation’ contraceptive, offering a beneficial risk/benefit profile to women in Canada and worldwide.”
MisterBlues
0
About Estelle®
Estelle® is Mithra’s novel combined oral contraceptive (COC) product candidate based on Estetrol (E4)15 mg and drospirenone (DRSP) 3 mg. E4 is a native estrogen that is produced by the human fetus, passing the maternal blood at relatively high levels during pregnancy. In two phase III clinical studies conducted in 4,400 women, Estelle® showed positive top-line results against primary efficacy and safety endpoints and achieved positive secondary endpoints including good bleeding profile, cycle control, and tolerability. Mithra has signed 10 licensing deals for Estelle® with a number of leading women’s health companies covering United States, Europe, Japan, South Korea, ASEAN, Russia, Brazil, Canada, Middle East, North Africa, Southern Africa and Australia. The product candidate is expected to be commercialized under the trademark Nextstellis® in Canada.

About Mithra

Mithra (Euronext: MITRA) is a Belgian biotech company dedicated to transforming Women’s Health by offering new choices through innovation, with a particular focus on contraception and menopause. Mithra’s goal is to develop products offering better efficacy, safety and convenience, meeting women’s needs throughout their life span. Its three lead development candidates are built on Mithra’s unique native estrogen platform, Estetrol (E4): Estelle®, a new era in oral contraception, PeriNesta®, the first complete oral treatment for perimenopause and Donesta®, the next-generation hormone therapy. Mithra also develops and manufactures complex therapeutics in the areas of contraception, menopause and hormone-dependent cancers. It offers partners a complete spectrum of research, development and specialist manufacturing at its technological platform Mithra CDMO. Active in more than 100 countries around the world, Mithra has an approximate headcount of 250 staff members and is headquartered in Liège, Belgium. www.mithra.com

About Searchlight Pharma Inc.

Searchlight Pharma Inc., headquartered in Montreal, aspires to become a leading Canadian-based specialty healthcare company through best-in class execution of the search, acquisition, commercialization, and focused development of innovative and unique specialty healthcare products that improve life-long human health and wellness. With a core focus on women’s health, urogynecology, and urology, our team is committed to improving people’s lives by bringing the right products to market. Follow us, learn more about what we do, and get to know our product portfolio at
www.searchlightpharma.com
MisterBlues
0
Als je bedenkt dat er in Canada maar zo'n 25 miljoen mensen leven en hoe groot die markt is:

the Canadian hormonal contraceptive market is worth approximately EUR 229 million a year, with combined oral contraceptives accounting for more than 66% of the market1. If approved by Health Canada, Nextstellis® is expected to be made available to patients in the Canadian market in mid 2021

Estelle heeft een goed veiligheidsprofiel en is effectief. Die goedkeuring komt er wel. In de USA en Canada. Je kunt dit jaar nog goedkoop aandelen Mithra kopen maar in 2021 komt de 'grote rest van de markt' erachter.
mentie
0
Europese beurzen terug bloedrood, terwijl er in Amerika record koersen worden neergepend.Hier wordt gekeken en geluisterd wat de witte clown rond tweet, In US zelf trekken ze zich daar weinig van aan. Brussel nog maar eens aan de staart van het peleton. Ene dag is het Umicore, andere dag is het KBC , en altijd voor een scheet wordt de rest meegezogen. Mithra kan momenteel spijtig genoeg geen stand houden op negatieve dagen. Maar het komt wel goed het aandeel, nog een beetje geduld en we zijn vertrokken.
Diedelie
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FilipVanderAa
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Je kan er geen staat op maken, da's wel het minste wat je kan zeggen. Ik denk dat 2021 ons een pak wijzer zal maken. 2020 is op vele vlakken een jaar om snel te vergeten
Diedelie
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Goed nieuw hé Filip, je weet toch hoe Mithra reageert op goed nieuws.... altijd zakken :-)
FilipVanderAa
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quote:

Diedelie schreef op 22 mei 2020 17:03:


Goed nieuw hé Filip, je weet toch hoe Mithra reageert op goed nieuws.... altijd zakken :-)


Oei, dan is het wachten tot ze failliet verklaard worden om die koers hier te zien vertrekken :)
MisterBlues
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Als Mithra later in 2021 die goedkeuring heeft voor vermarkting Estelle in Eur, USA, Can, Rus, LA, - wat kan zij daar dan mee verdienen gezien het feit dat:
ze dit altijd met partners doet (Mayne, Searchlight Pharma etc)
er ook nog forse schulden uit staan.

Ik heb nog nooit mee gemaakt dat een biotech in het zicht van de haven zo laag staat met een potentiële blockbuster. Meestal trekken dit soort aandelen nogal opportunistische beleggers en durfinvesteerders aan.

Iemand ooit een calculatie gemaakt? Iemand een idee waarom het aandeel nog zo laag staat?
FilipVanderAa
0
quote:

MisterBlues schreef op 23 mei 2020 08:45:


Als Mithra later in 2021 die goedkeuring heeft voor vermarkting Estelle in Eur, USA, Can, Rus, LA, - wat kan zij daar dan mee verdienen gezien het feit dat:
ze dit altijd met partners doet (Mayne, Searchlight Pharma etc)
er ook nog forse schulden uit staan.

Ik heb nog nooit mee gemaakt dat een biotech in het zicht van de haven zo laag staat met een potentiële blockbuster. Meestal trekken dit soort aandelen nogal opportunistische beleggers en durfinvesteerders aan.

Iemand ooit een calculatie gemaakt? Iemand een idee waarom het aandeel nog zo laag staat?


Ik denk dat het deels aan de beperkte free float, de notering in Brussel en de beperkte analisten coverage ligt. En zoals je zegt, potentiële blockbuster. We zullen moeten zien hoeveel vrouwen deze pil effectief gaan nemen.
FilipVanderAa
1
quote:

Diedelie schreef op 24 mei 2020 08:25:


Had ik maar verkocht op 37 euro :-) !


Ach, spijt komt altijd achteraf. Als, let wel als, estelle volgend jaar op de markt komt en een game changer blijkt te zijn, ga je blij zijn dat je niet verkocht hebt aan 37. Er zit nog heel wat in de pijplijn. Niet vergeten.
MisterBlues
0
quote:

FilipVanderAa schreef op 24 mei 2020 10:47:


[...]

Ach, spijt komt altijd achteraf. Als, let wel als, estelle volgend jaar op de markt komt en een game changer blijkt te zijn, ga je blij zijn dat je niet verkocht hebt aan 37. Er zit nog heel wat in de pijplijn. Niet vergeten.


Eens. Als je bedenkt hoeveel vrouwen De Pil gewoon bleven slikken toen de bijwerkingen bekend werden (borstkanker, secundaire geslachtskenmerken (baardgroei etc.)) dan kan je ook bedenken hoe fijn het is voor vrouwen De Pil (Estelle) te hebben zonder bijwerkingen!

De koers gaat einde 2021 door het dak, ver voorbij die top van 37!
MisterBlues
0
Mithra Launches a Research Programme on Estetrol's Effect in Covid-19 Treatment

- Women are more likely than men to be spared by Covid-19, with less severe infections and lower mortality rates
- Protective role of estrogen against human coronaviruses already demonstrated during the SARS infection, and currently being tested in the U.S. among hospitalized patients
- Mithra plans to develop a research program to study Estetrol (E4) mechanism of action in the treatment of Covid-19.

Liège, Belgium, 25 May 2020 - 7:30 CEST - Mithra (Euronext Brussels:

MITRA), a company dedicated to Women's Health, today announces its intention to launch a Phase II study program to assess the potential beneficial effect of Estetrol (E4) on Covid-19 infection. E4 is a naturally occurring estrogen produced by the liver of the human fetus, passing in maternal blood at relatively high levels during pregnancy.

Male-female immune differences

Recent epidemiological studies in China, Italy and the United States indicate that Covid-19 affects more men than women and more severely. Italy has suffered four times as many male deaths as female deaths1. In the United States, twice as many men as women die from Covid-19. One explanation for this gender disparity is believed to be biological differences in the immune system.

Estrogen's protective effect

This immuno-sexual difference was already observed with other infectious diseases caused by human coronaviruses, such as Severe Acute Respiratory Syndrome (SARS). An American study showed that male mice infected with the SARS virus developed more frequent, more severe and often more fatal infections than female mice2. In addition, removal of the ovaries or administration of anti-estrogens in females aggravated infection and increased fatalities, demonstrating the protective role played by estrogen. Estrogen acts on a protein known as Angiotensin Converting Enzyme 2 (ACE2) and enables its expression to be reduced. This ACE2 protein specifically serves as a gateway for certain coronaviruses (such as the one that causes Covid-19) to enter human cells.

“It would be very interesting to investigate further the effect of estrogen, in particular Estetrol, on the immune response of patients affected by Covid-19," comments Jean-Louis Vincent, Professor of Intensive Care at the Belgian University ULB and intensive care physician at the Erasmus University Hospital in Brussels. "Pregnant women, naturally under increased influence of estrogens, are relatively unaffected and
1 Andrea Remuzzi, Giuseppe Remuzzi, COVID-19 and Italy: what next?, The Lancet, 13 Mars 2020, doi.org/10.1016/S0140-6736(20)30627-9
2 Channappanavar et al., Sex-Based Differences in Susceptibility to Severe Acute Respiratory Syndrome Coronavirus Infection, The Journal of Immunology, April 2017, 198: 4046–4053.
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