Menopausal symptoms

Astellas is returning to the Super Bowl to help educate game viewers about VEOZAH and vasomotor symptoms (VMS), the most commonly reported menopause symptoms1 The "Fewer Hot Flashes, More Not Flashes" ad features women experiencing common moderate to severe hot flash and night sweat moments that impact their daily lives NORTHBROOK, Ill., Feb. 1, 2024 /PRNewswire/ -- Astellas Pharma US, Inc. (President: Mark Reisenauer, "Astellas") today announced that it will air a new version of its commercial for VEOZAH® (fezolinetant) just before Super Bowl kickoff on Sunday, February 11, 2024. VEOZAH is a nonhormonal treatment option approved by the U.S. Food and Drug Administration (FDA) to reduce the frequency and severity of moderate to severe vasomotor symptoms (VMS), also known as hot flashes and night sweats, due to menopause.1,2 The "Fewer Hot Flashes, More Not Flashes" TV spot is expected to reach millions of women in the U.S. tuning in who may be experiencing VMS due to menopause, as well as their partners, friends, and family.3,4 Jill Jaroch, Senior Director, Women's Health, Astellas "Approximately half of the audience are women, making the Super Bowl an incredible platform to showcase the different types of hot flash moments women in midlife may experience.4 At Astellas, we want all women to feel heard and their unique needs to be validated, which is why we are continuing to elevate this conversation. After all, nearly half of women in the U.S. going through menopause may experience moderate to severe VMS.3 We want to empower them to talk openly about their experiences and to have more informed discussions with their healthcare providers about VEOZAH." The TV spot showcases relatable hot flash moments, emphasizing that fewer interruptions from moderate to severe VMS due to menopause can be possible.2 When women with VMS are not having a hot flash, that's a not flash. The ad, as part of a larger consumer campaign, aims to encourage women to speak up and seek appropriate treatment options with their healthcare providers. To find more information about moderate to severe VMS due to menopause and this nonhormonal treatment option, visit VEOZAH.com. About VEOZAH® (fezolinetant) VEOZAH ® (fezolinetant) is a neurokinin 3 (NK3) receptor antagonist approved in the U.S. for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause.2 VEOZAH is not a hormone.2 VMS are the feelings of warmth in the face, neck, and chest, or sudden intense feelings of heat and sweating ("hot flashes" or "hot flushes").1 VEOZAH works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin B/dynorphin (KNDy) neuron to modulate neuronal activity in the thermoregulatory center of the brain (the hypothalamus) to reduce the frequency and severity of moderate to severe VMS due to menopause.1,2 About VMS due to Menopause VMS, characterized by hot flashes (also called hot flushes) and/or night sweats, are common symptoms of menopause.1 In the U.S., nearly half of women going through menopause may experience moderate to severe VMS.3 VMS can have a disruptive impact on women's daily activities and overall quality of life.5 U.S. Important Safety Information Do not use VEOZAH if you: have cirrhosis. have severe kidney problems or kidney failure. are taking certain medicines called CYP1A2 inhibitors. Ask your healthcare provider if you are not sure. Before you use VEOZAH, tell your healthcare provider about all of your medical conditions, including if you: have liver disease or problems. have kidney problems. have any medical conditions that may become worse while you are using VEOZAH. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VEOZAH may affect the way other medicines work, and other medicines may affect how VEOZAH works. What are the possible side effects of VEOZAH? VEOZAH can cause serious side effects, including: increased liver blood test values. Your healthcare provider will do a blood test to check your liver before you start taking VEOZAH. Your healthcare provider will also do this blood test at month 3, month 6, and month 9 after you start taking VEOZAH. Call your healthcare provider right away if you have the following signs and symptoms of liver problems: nausea vomiting yellowing of the eyes or skin (jaundice) pain in the right upper stomach (abdomen) The most common side effects of VEOZAH include: stomach (abdominal) pain diarrhea difficulty sleeping (insomnia) back pain hot flashes or hot flushes These are not all the possible side effects of VEOZAH. Tell your healthcare provider if you have any side effect that bothers you or does not go away. Call your healthcare provider for medical advice about side effects. You may report side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. For more information, please see the full Prescribing Information and Patient Product Information for VEOZAH (fezolinetant). About Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at . Cautionary Notes In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. References 1 Thurston RC. Vasomotor symptoms. In: Crandall CJ, Bachman GA, Faubion SS, et al., eds. Menopause Practice: A Clinician's Guide. 6th ed. Pepper Pike, OH: The North American Menopause Society, 2019:43-55. 2 Veozah [package insert]. Northbrook, IL: Astellas Pharma US, Inc. 3 Freeman EW, Sammel MD, Sanders RJ. Risk of long-term hot flashes after natural menopause: evidence from the Penn Ovarian Aging Study cohort. Menopause 2014;21(9):924-32. 4 Men, Women and the Super Bowl: The Science Marketers Should Note, Martec Group. 5 English M, Stoykova B, Slota C, et al. Qualitative study: burden of menopause-associated vasomotor symptoms (VMS) and validation of PROMIS sleep disturbance and sleep-related impairment measures for assessment of VMS impact on sleep. J Patient Rep Outcomes 2021;5(37):1-13. SOURCE ASTELLAS PHARMA INC.

Independent global leaders in medical research on women’s health, Professor Amanda Black and Professor Wulf Utian, to deliver two presentations each on E4E4 is a key active pharmaceutical ingredient in Estelle® and Donesta® productsDifferentiated efficacy and safety in contraception and postmenopausal symptoms from positive Phase 3 trials Liege, Belgium, 27 September 2023 – 7:00 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces there will be four presentations on Estetrol (E4) native estrogen at the North American Menopause Society (NAMS) 2023 Annual Meeting, being held September 27-30 in Philadelphia, USA. E4 is a key active pharmaceutical ingredient in both Mithra’s marketed contraceptive Estelle® and its next generation hormone therapy product candidate for postmenopausal symptoms, Donesta®. Amanda Black MD, MPH, FRCSC, Professor of Obstetrics and Gynecology at The University of Ottawa, will hold an independent oral presentation on the use of E4 for contraception and menopause. Dr. Black will be discussing the science and safety behind the use of E4 in the menopause at the opening symposium and will present some of the data on the effects of E4 on breast tissue. Dr. Wulf Utian1, MD, PhD, DSc, Executive Director Emeritus and Honorary Founding President of NAMS, who is considered to be one of the world’s authorities on menopause and women’s health, will hold an oral presentation on the Phase 3 results of E4 in postmenopausal symptoms. The data, from two multi-center, double-blind, placebo-controlled trials with 2,550 postmenopausal women aged 40-65, show beneficial effects from 12-week treatment with E4. These include a significant increase in high-density lipoprotein (HDL) – or “good” – cholesterol and a significant decrease in the ratio total of HDL cholesterol to low-density lipoprotein (LDL) “bad” cholesterol and lipoprotein. There was also a significant decrease in fasting plasma glucose and HbA1c average blood glucose (glycemia) level. Also observed were trends for decreases in insulin and Homeostatic Model Assessment for Insulin Resistance (HOMA-IR). Dr. Black and Dr. Utian will each also hold poster presentations on E4 at NAMS 2023. Graham Dixon, Chief Scientific Officer of Mithra, commented: “The data will demonstrate that E4 treatment has a favorable safety profile, including a low impact on normal and malignant breast tissue, thanks to its unique mode of action which means it has tissue selective activity, unlike all other estrogens. It has also been shown to be effective at decreasing vasomotor symptoms in postmenopausal women. The evidence clearly shows the potential of E4 to offer women differentiated options to support their independence during child-bearing years and maintain their health during menopause.” Mithra has previously reported positive results from Phase 3 trials, showing strong efficacy and a favorable safety profile for contraception, for Estelle®, and separately, a statistically significant reduction in vasomotor symptoms, or hot flushes and night sweats, in postmenopausal women, with Donesta®. Dr. David Horn Solomon, Chief Executive Officer of Mithra, commented: “We are proud that Dr. Black and Dr. Utian, two globally recognized experts on women’s health, are presenting this clinical research on our exciting E4 developments. Our scientific founder, Professor Jean-Michel Foidart, was amongst the first to characterize and recognize the potential of this native and selective estrogen, which is produced by the human fetus during pregnancy, passing into maternal blood at relatively high levels and offering unique benefits. His research and development efforts allowed Mithra to develop and test E4 as the key innovative active pharmaceutical ingredient in Mithra’s oral contraceptive Estelle® and its Donesta® next generation hormone therapy drug candidate. Our marketing partners are currently accelerating the ongoing commercial launches of Estelle®, globally; we are finalizing our application for U.S. marketing authorization of Donesta®, for submission later this year. These data presented at NAMS 2023 illustrate the significant goals we are pursuing to provide women with a new era in oral contraception and the next generation hormone therapy for menopause. Our mission is for these and other innovative products to improve women’s health and independence from young adulthood through mid-life and beyond.” Details of the presentations at NAMS 2023 are as follows: Estetrol (E4): A Promising New Treatment for the Spectrum of Menopausal Symptoms Presenter: Amanda Black – Poster The Effect of Estetrol (E4) on Patient-Reported Outcome Measures in Postmenopausal Women – Results From a Phase 3 Trial Presenter: Wulf Utian – Poster Estetrol (E4), a Promising New Treatment for Menopausal Vasomotor Symptoms (VMS): Beneficial Lipid and Carbohydrate Metabolism in a Phase 3 Randomized, Double-blind, Placebo-Controlled Trial Presenter: Wulf Utian – Oral Time: 4:30-4:45pm EST, Thursday 28 September Location: Concurrent Session 2—Oral Abstract Presentations; Grand Ballroom (A–D)—Fifth Floor Estetrol (E4) for contraception and Menopause: Where is the Science? Presenter: Amanda Black – Invited Oral (Independent) Time: 10:10-10:30am EST, Wednesday 27 September Location: Opening Symposium—Precision Oncology for Midlife Women; Grand Ballroom (E–L)—Fifth Floor For more information, please contact: Mithra Pharmaceuticals SAAlex Sokolowski, PhDHead of Investor Relationsinvestorrelations@mithra.com+32 (0)4 349 28 22Frédérique DepraetereCommunications Directorinfo@mithra.com +32 (0)4 349 28 22 Chris MaggosCohesion Bureauchris.maggos@cohesionbureau.com+41 79 367 6254 About Mithra Mithra Pharmaceuticals SA (Euronext: MITRA) is a Belgian biopharmaceutical 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. Mithra explores the potential of the unique native estrogen estetrol in a wide range of applications in women health and beyond. After having successfully launched the first estetrol-based product in 2021, the contraceptive pill Estelle®, Mithra is now focusing on its second product Donesta®, the next-generation hormone therapy. Mithra also offers partners a complete spectrum of solutions from early drug development, clinical batches and commercial manufacturing of complex polymeric products (vaginal ring, implants) and complex liquid injectables and biologicals (vials, pre-filled syringes or cartridges) at its technological platform Mithra CDMO. Active in more than 100 countries around the world, is headquartered in Liège, Belgium. www.mithra.com ESTELLE® and DONESTA® are registered trademarks of Mithra Pharmaceuticals or one of its affiliates. Important information The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The Company's actual results may differ materially from those predicted by the forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law. Subscribe to our mailing list on investors.mithra.com to receive our press releases by email or follow us on our social media :Linkedin • Twitter • Facebook 1 Dr. Utian is a member of the Mithra Advisory Board. Attachments 2023-09-27_Mithra NAMS FR_Final 2023-09-27_Mithra NAMS_ENG_Final

The menopause market is anticipated to surge significantly in the coming years due to the emergence of new products in the pipeline. In addition, persistently rising cases of menopause in the forecast period will help increase the menopause treatment market. LAS VEGAS, Sept. 12, 2023 /PRNewswire/ -- DelveInsight's Menopause Market Insights report includes a comprehensive understanding of current treatment practices, menopause emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan]. Key Takeaways from the Menopause Market Report As per DelveInsight analysis, the menopause market size in the 7MM was approximately USD 11 billion in 2022. According to the assessment done by DelveInsight, the total number of women in menopause in the 7MM comprised approximately 100 million cases in 2022 and are projected to increase during the forecast period. Leading menopause companies such as Viramal Limited, Simbec Research, Estetra, Mithra Pharmaceuticals, Bayer, Nerre Therapeutics Ltd., Mitsubishi Tanabe Pharma America Inc., MenoGeniX, QUE Oncology, Fervent Pharmaceuticals, and others are developing novel menopause drugs that can be available in the menopause market in the coming years. The promising menopause therapies in the pipeline include Transdermal Estradiol Cream (VML-0203), DONESTA (E4, Estetrol), Elinzanetant (BAY3427080), MT-8554 (Elismetrep), MNGX-100 (Filgrastim/G-CSF), Q-122 (MSX-122), FP-101, and others. Discover which therapies are expected to grab the major menopause market share @ Menopause Market Report Menopause Overview Menopause is a natural biological process that marks the end of a woman's reproductive years. It usually occurs between the ages of 45 and 55, with an average age of around 51. This phase is characterized by a decline in the production of hormones like estrogen and progesterone, leading to the cessation of menstruation and fertility. The primary cause of menopause is the aging of the ovaries, which results in a reduced number of eggs and a decline in hormone production. However, certain medical procedures like hysterectomy, chemotherapy, and radiation therapy can induce menopause prematurely. Menopause brings about a range of symptoms that can vary widely from woman to woman. Common menopause symptoms include hot flashes, night sweats, mood swings, irritability, fatigue, vaginal dryness, and sleep disturbances. These symptoms occur due to the hormonal fluctuations that take place during the transition to menopause. Diagnosing menopause is often based on a woman's age, medical history, and symptoms. A key factor is the absence of menstruation for 12 consecutive months, signaling the end of the reproductive period. In some cases, healthcare providers may recommend blood tests to measure hormone levels, such as follicle-stimulating hormone (FSH) and estrogen, to confirm the onset of menopause. Menopause Epidemiology Segmentation DelveInsight estimates that there were approximately 100 million total women in menopause in the 7MM in 2022. For the age-specific analysis, the number of cases of menopause were distributed across various age groups, such as <40 years, 40–50 years, 51–60 years, and 61–65 years, in the 7MM. As per the analysis, the highest number of cases were estimated in the age-group 51-60 years and the lowest in <40 years with 64 million and 3.4 million cases, respectively in 2022. The menopause market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total Number of Women in Menopause Stage-Specific Distribution of Women in Menopause Age-Specific Distribution of Women in Menopause Number of Women in Menopause with Vasomotor Symptoms Number of Women in Menopause with Moderate-to-Severe Vasomotor Symptoms Menopause Treatment Market The North American Menopause Society (NAMS) suggests waiting until the hot flashes become troublesome to the woman before seeking treatment. The intensity of symptoms, an assessment of treatment-related risks, and the woman's views towards menopause and drugs should all be considered before starting treatment. Duavee (bazedoxifene acetate/conjugated estrogens) is the first and only medicine that combines CE with an estrogen agonist/antagonist, commonly known as a selective estrogen receptor modulator (SERM), for the treatment of menopausal VMS. Duavee employs bazedoxifene rather than progestin to help protect the uterine lining from hyperplasia that may occur as a result of estrogen-only treatment. Many women use non-prescription therapies to address disorders such as hot flashes, such as isoflavones, black cohosh, and progesterone-containing hormone lotions. The clinical evidence for the efficacy and long-term safety of these therapies is insufficient. Furthermore, most over-the-counter medications for hot flashes are classified as nutritional supplements and, as such, are not regulated by the US Food and Drug Administration. Prescription medications for various purposes that have demonstrated some benefit in alleviating hot flashes are available for women who have hot flashes but cannot undergo hormone therapy. Certain prescription antidepressants may reduce hot flashes in women, including those with a history of breast cancer. Others include gabapentin, clonidine, and methyldopa. The NAMS recommends that women who need relief from mild menopause-related hot flashes first consider lifestyle changes such as manipulating the environment to keep the core body temperature cool, getting regular exercise, quitting smoking, and using relaxation techniques such as paced respiration. To know more about menopause treatment, visit @ Menopause Treatment Drugs Key Menopause Therapies and Companies Transdermal Estradiol Cream (VML-0203): Viramal Limited/Simbec Research DONESTA (E4, Estetrol): Estetra/Mithra Pharmaceuticals Elinzanetant (BAY3427080): Bayer|Nerre Therapeutics Ltd. MT-8554 (Elismetrep): Mitsubishi Tanabe Pharma America Inc. MNGX-100 (Filgrastim/G-CSF): MenoGeniX Q-122 (MSX-122): QUE Oncology FP-101: Fervent Pharmaceuticals Learn more about the FDA-approved drugs for menopause @ Drugs for Menopause Treatment Menopause Market Dynamics The menopause market dynamics are undergoing significant shifts as societal awareness of women's health and well-being continues to grow. With an aging population and increasing focus on women's empowerment, there's a heightened demand for innovative products and services addressing the physical and emotional challenges associated with menopause. This has spurred a surge in research and development, leading to the creation of a diverse range of hormone replacement therapies, herbal supplements, lifestyle apps, and personalized health plans. As more women seek effective and holistic solutions, companies are embracing a more consumer-centric approach, tailoring their offerings to individual needs and preferences. Additionally, discussions around menopause are becoming less taboo, allowing for open dialogue and information-sharing, further shaping the menopause market dynamics by fostering a supportive ecosystem for women navigating this life stage. However, despite the potential for growth, this menopause market is not without its barriers. Stringent regulatory processes for hormonal treatments and supplements, coupled with concerns about product safety and efficacy, pose challenges for menopause market entrants. Additionally, cultural stigmas and misinformation surrounding menopause still exist in certain societies, inhibiting open discussions and the adoption of new solutions. Economic disparities and limited access to healthcare further compound these issues, preventing equal menopause market penetration. Overcoming these barriers requires a multi-faceted approach, involving education, regulatory reforms, and inclusive product development, to truly tap into the menopause market's potential. Scope of the Menopause Market Report Therapeutic Assessment: Menopause current marketed and emerging therapies Menopause Market Dynamics: Attribute Analysis of Emerging Menopause Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's Views, Analyst's Views, Menopause Market Access and Reimbursement Discover more about menopause drugs in development @ Menopause Clinical Trials Table of Contents Related Reports Hot Flashes Pipeline Hot Flashes Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key hot flashes companies, including Veru Healthcare, Fervent Pharmaceuticals, Ogeda, Bayer, Lundbeck A/S, TherapeuticsMD, MenoGeniX, Mitsubishi Tanabe Pharma, QUE Oncology, Pherin Pharmaceuticals, among others. Hot Flashes Market Hot Flashes Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key hot flashes companies, including Veru Healthcare, Fervent Pharmaceuticals, Ogeda, Bayer, Lundbeck A/S, TherapeuticsMD, MenoGeniX, Mitsubishi Tanabe Pharma, QUE Oncology, among others. Menopause Global Market Menopause Market Insights, Competitive Landscape, and Market Forecast – 2028 report deliver an in-depth understanding of the disease, market trends, market drivers, market barriers, and key menopause companies including ISIDEN, Novapharm, Arkopharma, Pileje, Thermamex, ÉLERTÉ Laboratories, Serelys Pharma, Besins Healthcare, Bayer, ITALFARMACO S.p.A, Pfizer Inc, Mylan NV, Teva Pharmaceuticals, TherapeuticsMD, Inc, Novo Nordisk, Novartis, Millicent Pharma, PADAGIS LLC, Vertical Pharmaceuticals LLC, Amgen, among others. Vasomotor Symptoms of Menopause Pipeline Vasomotor Symptoms of Menopause Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key vasomotor symptoms of menopause companies, including Mithra Pharmaceuticals, Acer Therapeutics, QUE Oncology, Bayer, Endoceutics, Astellas Pharma, Mitsubishi Tanabe Pharma, MenoGenix, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP