Menopausal syndrome

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.

Not intended for UK Media New Phase II study NIRVANA aims to explore efficacy and safety of investigational compound elinzanetant as a non-hormonal treatment for sleep disturbances associated with menopause (SDM) SDM may have an impact on women’s quality of life, work productivity as well as their physical and mental wellbeing The new Phase II study expands upon the ongoing clinical development program of elinzanetant, an investigational first dual neurokinin-1,3 (NK-1, 3) receptor antagonist BERLIN--(BUSINESS WIRE)-- Bayer, a global leader in women’s healthcare, announced today the expansion of the clinical development program for the investigational compound elinzanetant. The first study participants were recently enrolled into NIRVANA, an exploratory Phase II study to evaluate the efficacy and safety of elinzanetant in women with sleep disturbances associated with menopause (SDM). Together with vasomotor symptoms (also known as VMS or hot flashes) and mood symptoms, sleep disturbances belong to the most frequent and disruptive symptoms associated with menopause.1 Approximately 40% to 60% of women experience sleep disturbances during the menopausal transition, which may include trouble falling asleep or staying asleep potentially causing a negative impact on women’s quality of life and limit their daily activities, including performance at work. 2,3 SDM may also be associated with negative effects on metabolism, body fat gain, poor cardiovascular health in later life, cognitive health decline, and depressive symptoms.4,5 Current treatments do not specifically target sleep disturbances associated with menopause. “By adding NIRVANA to our broad clinical development program, we are further exploring the potential of elinzanetant to address sleep disturbances associated with menopause, an area of important unmet need in women’s health,” said Dr. Christian Rommel, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Global Head of Research and Development. “Sleep is an incredibly complex aspect of health and the human experience, and unfortunately, its importance is often underestimated and undervalued – for those experiencing menopause this is especially the case,” said Hadine Joffe, M.D., M.Sc, Professor of Psychiatry in the Field of Women’s Health based at Brigham and Women’s Hospital in Boston, an experienced psychiatrist and sleep researcher in women’s mental health.. The NIRVANA Phase II trial is a multi-center, double-blind, randomized, parallel-group, placebo-controlled interventional study. It is intended to randomize approximately 78 participants in eight countries to investigate the efficacy and safety of elinzanetant in women with sleep disturbances associated with menopause (SDM). The primary endpoint for the NIRVANA study is the efficacy of elinzanetant on Wakefulness After Sleep Onset (WASO) at week 4 as measured by polysomnography. Additionally, Bayer announced positive topline results of the pivotal Phase III studies OASIS 1 and 2 evaluating the efficacy and safety of the investigational compound elinzanetant for the treatment of moderate to severe VMS associated with menopause versus placebo. Elinzanetant successfully met all four primary endpoints in both studies demonstrating statistically significant reductions in the frequency and severity of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) from baseline to week 4 and 12 compared to placebo. Both studies also achieved all three key secondary endpoints showing a statistically significant reduction in the frequency of VMS from baseline to week 1, as well as statistically significant improvements in sleep disturbances and menopause-related quality of life compared to placebo. The safety pro in the OASIS 1 and 2 studies is overall consistent with previously published data2,6 on elinzanetant. About the NIRVANA Study NIRVANA is an exploratory Phase II randomized, parallel-group treatment, double-blind study. The primary objective is to explore the efficacy of elinzanetant on sleep disturbances associated with menopause (SDM) as determined by polysomnography (PSG). PSG is a validated method to study sleep and underlying causes of sleep disturbances. Additional objectives include exploring the efficacy of elinzanetant on SDM as determined by patient-reported outcomes and evaluating the safety of elinzanetant for the treatment of SDM. More information can be found at . The Phase II study NIRVANA is based on improvements in sleep disturbances observed in the Phase IIb study SWITCH-1, which investigated the efficacy and safety of four different doses of elinzanetant compared to placebo in women with moderate to severe vasomotor symptoms associated with menopause. It also indicated improvements in sleep disturbances as assessed by the global Pittsburgh Sleep Quality Index (PSQI) and the total Insomnia Severity Index (ISI) scores with elinzanetant 120 mg once daily compared to placebo. Full results have been published in March 2023 in Menopause - The Journal of the Menopause Society.2 About the OASIS Clinical Development Program The Phase III clinical development program of elinzanetant, OASIS, currently comprises four Phase III studies: OASIS 1, 2, 3 and 4. The OASIS 1, 2 and 3 studies investigate the efficacy and safety of elinzanetant 120 mg in women with moderate to severe VMS associated with menopause. The OASIS 4 study is an expansion of the clinical phase III program and investigates the efficacy and safety of elinzanetant in women with moderate to severe VMS caused by endocrine therapy for treatment or prevention of breast cancer. The design and dosing of the Phase III clinical development program is based on the positive data from two Phase II studies (RELENT-1 and SWITCH-1). RELENT-1 was a Phase Ib/IIa study investigating the safety, pharmacokinetics and preliminary efficacy of elinzanetant. SWITCH-1 was a Phase IIb study investigating the efficacy and safety of four different doses of elinzanetant compared to placebo in women with VMS. About Elinzanetant Elinzanetant is a first dual neurokinin-1,3 (NK-1,3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily. Elinzanetant may address moderate to severe VMS by modulating a group of estrogen sensitive neurons in the hypothalamus region of the brain (the KNDy neurons) which, with the decrease of estrogen, become hypertrophic and lead to a hyperactivation of the thermoregulatory pathway, consequently disrupting body heat control mechanisms resulting in VMS. Elinzanetant may also decrease sleep disturbances associated with menopause. About Menopause By 2030, the world population of women experiencing menopause is projected to increase to 1.2 billion, with 47 million new women entering this phase each year.7 Menopause is a transitional phase in women’s lives, related to the progressive decline of ovarian function, and which usually occurs in women during their 40s or early 50s. It can also be the result of surgical or medical treatment, for example breast cancer treatment. The hormonal decline can lead to various symptoms which can substantially affect a woman’s health, quality of life, healthcare utilization and work productivity. The most frequently reported and disruptive symptoms during the menopausal transition are VMS, sleep disturbances and mood changes. Addressing these symptoms is key to maintaining functional ability and quality of life in menopause which is highly relevant from both a healthcare and socio-economic perspective. About Women’s Healthcare at Bayer Women’s Health is in Bayer’s DNA and as a global leader in women’s healthcare Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in the area of menopause. Additionally, Bayer intends to provide 100 million women per year in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to . Find more information at Follow us on LinkedIn: Bayer | Pharmaceuticals kw (2024-0010e) Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. References 1 Baker, FC; de Zambotti, M; Colrain, IM, et al. (2018). Sleep problems during the menopausal transition: prevalence, impact, and management challenges. Nat Sci Sleep; 10: 73–95. 2 Simon, JA; Anderson, RA; Ballantyne, E, et al. (2023). Efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist for vasomotor symptoms: a dose-finding clinical trial (SWITCH-1). Menopause; 30 (3): 239–246. 3 Nappi, RE; Kroll, R; Siddiqui, E, et al. (2021). Global cross-sectional survey of women with vasomotor symptoms associated with menopause: prevalence and quality of life burden. Menopause; 28 (8): 875–882. 4 Nappi, RE; Simoncini, T (2021). Menopause transition: a golden age to prevent cardiovascular disease. Lancet Diabetes Endocrinol; 9 (3): 135–137. 5 Proserpio, P ; Marra, S ; Campana, C ; Agostoni, E. C.; Palagini, L ; Nobili, L; Nappi, RE (2020) Insomnia and menopause: a narrative review on mechanisms and treatments, Climacteric, 23:6, 539-549 6 Trower, M; Anderson, RA; Ballantyne, E, et al. (2020). Effects of NT-814, a dual neurokinin 1 and 3 receptor antagonist, on vasomotor symptoms in postmenopausal women: a placebo-controlled, randomized trial. Menopause; 27 (5): 498–505. 7 Hill, K (1996). The demography of menopause. Maturitas; 23 (2): 113–127.

Mithra to receive EUR 1.5 million milestone payout as a result of the signing of the agreement Additional licensing payout of EUR 15.55 million in regulatory and sales milestones, along with tiered royalties on annual net sales Searchlight anticipates filing of Canadian regulatory submission for DONESTA® as a treatment for the symptoms of menopause in H1 2024 Both companies aim to provide innovative solutions to women by partnering on MYRING®, ESTELLE®, and now DONESTA®. Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, and Searchlight Pharma Inc. (“Searchlight”), a private Canadian-specialty pharmaceutical company, have signed a License and Supply Agreement for the Canadian rights to DONESTA®, Mithra’s investigational, next generation medicine, containing Estetrol, for the treatment of the symptoms of menopause. The signing of the agreement activates a first milestone payout to Mithra of EUR 1.5 million. The two companies signed a binding term sheet for a licensing agreement in July 2023. Under the terms of the agreement, Searchlight will have the exclusive sales and marketing rights for DONESTA® in Canada. Mithra is expected to receive an additional EUR 15.55 million in regulatory and sales-related milestone payments, plus tiered double-digit royalties on total Canadian annual net sales. Searchlight will be responsible for obtaining and maintaining any regulatory approvals required to market and sell DONESTA® in Canada. David Horn Solomon-- Chief Executive Officer of Mithra said, “The finalization of the DONESTA® licensing agreement for Canada is another important milestone as we continue to deliver on Mithra’s strategy and unlock the value in our business. We are delighted to strengthen our partnership with Searchlight, which is well-positioned to launch the product and provide patients in Canada access to this differentiated-therapeutic candidate. We also continue to have active discussions with multiple parties, as we consider DONESTA® marketing partners for the U.S., China, and other key markets.” Searchlight has repeatedly ranked among the top-growth companies in Canada, with one of the largest portfolios of women’s health products and associated sales team in the Canadian market. Mithra and Searchlight have a continuing partnership for NEXTSTELLIS® the first Estetrol (E4) based combined oral contraceptive product (ESTELLE® project), and HALOETTE® vaginal contraceptive ring in Canada (MYRING® project). NEXTSTELLIS® was launched in Canada in Q3 2021, while HALOETTE® was launched in Q1 2022. “We are pleased to continue our relationship with Mithra through the signing of the license agreement for DONESTA®,” said Mark Nawacki, Searchlight’s President and Chief Executive Officer. “This is the third licensing arrangement we have completed with Mithra. Their ongoing confidence in Searchlight confirms that we provide the optimal commercial platform for our partners to ensure that each product gets the support it needs to succeed. An unwavering commitment to improve women’s health in Canada has been at the core of Searchlight’s mission since its inception. Particularly now, when the attention and focus on the unmet need around the menopause and its impacts on quality of life is being so openly highlighted and discussed in our society, we are proud to be in a position to deliver DONESTA®, a new and truly innovative option, to help Canadian women address their unmet needs in managing the symptoms of menopause.” In 2022, Mithra announced topline efficacy results of the DONESTA® Phase 3 clinical program, which demonstrated a meaningful reduction in the frequency and severity of vasomotor symptoms from baseline and compared to placebo, with all co-primary efficacy endpoints met with statistical significance. In March 2023, Mithra also announced promising topline safety results from the DONESTA® Phase 3 trial in North America (C302). The results will support marketing authorization filings scheduled in the U.S. in H2 2023 and in Canada in 2024. Primary safety data are anticipated for Europe in H1 2024. 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®, DONESTA®, MYRING®, HALOETTE®, and NEXTSTELLIS® are registered trademarks of Mithra Pharmaceuticals or one of its affiliates. Searchlight Pharma Inc., headquartered in Montreal, is a leading Canadian-based specialty healthcare company that executes best-in-class search, acquisition, commercialization, and focused development of innovative and unique specialty healthcare products. Following its acquisition of Miravo Healthcare in March 2023, Searchlight’s core promoted products now focus on women’s health, dermatology, allergy, pain management and hospital specialty markets, and its team is committed to improving people’s lives by bringing the right products to market. Follow Searchlight, learn more about what it does, and get to know its product portfolio at www.searchlightpharma.com. The content above comes from the network. if any infringement, please contact us to modify.