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Mithra 2023. The Rise of the Phoenix.

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  1. Brahim_av 9 juli 2023 15:00
    quote:

    JdeFL schreef op 8 juli 2023 11:11:

    "while monthly supplies of Twirla and Nextstellis can be more than $200.
    That’s certainly not cheap for people without insurance, especially compared with a generic pill that costs $20 or less per month."
    fortune.com/2023/04/05/birth-control-... (bijzonder interessant art. geleend bij de buren)

    Blijkt daaruit ook dat verzekeringen in de VS niet happig zijn om tussen te komen in nieuwere (lees: veel duurdere) contraceptie, en je ziet waarom de verkoop van nextellis niet die mooie ramp up heeft die nodig is.
    Komt daar bij dat nieuwe contraceptie in de VS dus moeilijk winstgevend te vermarkten is, dan kunnen we ons afvragen of er nog wel een US donesta deal komt. Dat zou a. een gat van 50M$ in het budget betekenen, en b. winstgevendheid op lange termijn een serieuze knauw geven.

    'k Zie zelf ook niet in waarom verzekeraars een 10* zo duur middel zouden moeten vergoeden. Die prijs wordt immers bepaald door de bedrijven zelf, hun probleem zou ik denken. Dus uit die hoek verwacht ik weinig soelaas.

    Weer een serieuze knauw in de waardering van Mithra... Helaas. De vraag is al niet meer wanneer die US er komt, maar of er ueberhaupt een zal zijn.

    Inderdaad, ik zei het al eerder, een partner vinden in de VS is geen evidentie. Het gaat niet alleen om de verzekeringsdekking voor Donesta, maar ook om de perceptie die er bestaat hij HRT hormone replacement therapy.
    Die markt is al voor een groot deel ingenomen en een nieuw product moet zich kunnen differentiëren van de concurrentie. Een potentiële partner zal daar zeer sterk in moeten investeren, gemakkelijk $100M nodig voor de eerste marketing en sales processen nodig. Zeggen dat het een beter veiligheidsprofiel heeft is niet voldoende. Er is nog geen solide bewijs. Dit zal wellicht pas na de PASS studie (post approval) een andere wending kunnen nemen, maar die is pas voorzien voor 2029.

    A PASS study will start in 2023. Its main focus and purpose will be to characterize and compare
    the Venous Thromboembolism risks of E4/DRSP with EE/LNG.

    Deze post studie zou Estelle risicoprofiel moeten vergelijken met risicoprofiel van de klassieke pil op basis van EE.
  2. Brahim_av 11 juli 2023 17:09
    Phase 3b Trial of Fezolinetant Shows Positive Topline Results for Treatment of VMS Due to Menopause

    Jun 28, 2023
    Study evaluated 24-week efficacy and safety of Astellas’ fezolinetant in women considered unsuitable for hormone therapy

    TOKYO, June 27, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced positive topline results from the Phase 3b DAYLIGHT clinical trial for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2

    The study, comprised of more than 450 women considered unsuitable for hormone therapy, met the primary objective showing statistically significant reduction from baseline in the frequency of moderate to severe VMS to week 24 for fezolinetant 45 mg once daily versus placebo. Serious treatment emergent adverse events (TEAE) occurred in less than 5% of patients, and the most common TEAEs were COVID-19 and headache. Detailed results will be submitted for publication and for consideration at an upcoming medical meeting.
  3. Brahim_av 11 juli 2023 17:24
    www.pharmavoice.com/news/menopause-tr...

    Women’s healthcare investments are hot. So where are the new menopause drugs?
    NK3 receptor antagonists offer a new option, but experts say more are needed.

    Published July 5, 2023
    By Kelly Bilodeau

    When the COVID-19 pandemic hit the U.S. in early 2020 it briefly shut down clinical trials worldwide. Astellas Pharma was in the midst of phase 3 testing for Veozah, its now-approved nonhormonal drug to treat vasomotor symptoms — hot flashes and night sweats in menopausal women — which it assumed would become low priority amidst the crisis.

    “We thought, this is a vasomotor symptom trial. I’m sure we’re going to put this on the back burner,” Marci English, vice president and head of biopharma development at Astellas, said. “We were so wrong. We had (employees at) sites saying ‘You don’t understand. I have patients calling me saying, You’re not closed, right? You’re going to stay open for this trial?’ That really just speaks to the demand for products like this.”

    The FDA’s May approval of Veozah was a boon to those looking for a new way to treat hot flashes, which affect up to 80% of menopausal people. By blocking neurokinin 3 (NK3), a brain receptor that helps regulate body temperature, the drug is particularly in-demand option for those who can’t or don’t want to use hormone replacement therapy.

    In a series of phase 3 trials, nearly 60% of women saw the frequency of their hot flashes cut in half after 12 weeks, English said. Some 30% saw them cut by 75%, and just over 10% of patients saw their hot flashes eliminated. The effect was maintained at the one-year mark. While traditional hormone therapy can reduce hot flash frequency and intensity by 90%, Veozah has the advantage of working quickly — usually within a week. Hormone therapies, on the other hand, can take up to a month to kick in.

    Another NK3 receptor antagonist, elinzanetant from Bayer, is also making its way through the pipeline using a similar nonhormonal approach, while also targeting the NK1 receptor to steady the body’s internal thermostat. In a phase 2b study, elinzanetant showed a statistically significant reduction in the frequency and severity of hot flashes, and produced mild to moderate side effects, said Dr. Yesmean Wahdan, vice president of medical affairs and women’s health at Bayer. More details about how well it works will come with top-line results from its ongoing phase 3 study, which will likely be released in early 2024.

    Other menopause-focused drugs are also in the works including Dare Bio’s two early-stage candidates— a hormone-based therapy for hot flashes and a nonhormonal, tamoxifen-based treatment for vulvar and vaginal atrophy. Mitsubishi Tanabe Pharma, meanwhile, also has a phase 2 drug, Elismetrep, for hot flashes.

    Even so, the menopause drug pipeline seems meager in the face of demand. Some six thousand people enter menopause every day in the U.S. experiencing a range of well-known symptoms that last, on average, for seven years. And although its effects can vary from bothersome to debilitating, menopause is left untreated in six in every 10 women, English said.

    In general, the femtech sector — including telehealth and device companies — is in the midst of a boom. According to FemHealth Insight Data, over 60% of femtech startups were launched in the last five years. But the general momentum in women’s health has yet to translate into a strong pipeline of new drugs.

    Last year, PhRMA released a list of drugs in development for women’s health, which only included six drugs for menopause symptoms. By comparison, PhRMA listed 200 in the works for women’s cancers and 34 for dry eye disease.

    Now the pressure is on to get more menopause treatments going.

    “Socially, you see that there is this intense wave around supporting menopause,” said Wahdan.
    Women with large social media platforms, government officials and celebrities have been talking publicly about their menopause symptoms, struggles, and how they’re no longer willing to just grin and bear it.

    “By 2030, the world population of menopausal and postmenopausal women is projected to be around 1.2 billion, with 47 million new entrants each year,” Wahdan said. “It’s been long enough that women have suffered in silence.”

    The question is: Will more drug companies step up to fill the menopause pipeline?

    A stagnant pipeline
    Hormone replacement therapy has long been a mainstay in menopause treatment, but isn’t recommended for patients with certain health conditions, including a history of breast cancer, endometrial cancer or cardiovascular disease. And some might be hesitant to take hormones due to potential — or perceived — health risks such as the slight increase in the risk of certain cancers. They’ve also been linked to a higher risk of dementia and gallbladder disease.

  4. NewInTown 12 juli 2023 18:48
    quote:

    Marbella schreef op 12 juli 2023 11:38:

    Geen volume, geen interesse meer en allemaal jullie geld kwijt...dank u Leon & co.
    Ach Marbella, sometimes you win, sometimes you lose. Een gokje wagen mag toch? We zien wel hoe het hier uitdraait, maar in het slechtste geval vergaat mijn wereld er niet door hoor. Er zijn andere die me genoeg opbrengen. Het is echter wel zielig hoe sommigen hier dagelijks rondhangen en het nodig vinden om iedere daling inhoudsloze boodschappen te posten. Met welk doel? Iedereen maakt wel zelf uit wat hij met dit aandeel doet. Doe je het uit goede inborst om anderen te informeren? Lachwekkend. Breng dan iets meer gefundeerd.
  5. Blik dekkende afbijt 13 juli 2023 14:05
    quote:

    Catalina schreef op 13 juli 2023 13:46:

    Partijen die Mithra gebruiken als speelbal om geld te verdienen beginnen weer een pump and dump om de lakens even op te schudden. Dagen van +10% worden altijd opgevolgd door drie dagen van -4%.

    Zo voedt men zich met de arme hebzuchtige beleggers.
    goede middag bbq?
  6. forum rang 7 JdeFL 14 juli 2023 09:16
    quote:

    Hopper58 schreef op 13 juli 2023 15:16:

    'Perrigo’s stock soars 6% after FDA approves its over-the-counter daily oral contraceptive'

    www.marketwatch.com/story/perrigos-st...
    Kan toch moeilijk die koersstijging gisteren verklaren. 't Is gewoonweg nog meer concurrentie. Generisch (veronderstel ik), en zonder voorschrift.
    Nou ja, waar ik aan dacht, is het dus ook niet.
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