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Study evaluated 24-week efficacy and safety of Astellas' fezolinetant in women considered unsuitable for hormone therapy TOKYO, June 27, 2023 /PRNewswire/ -- 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. Marci English, Vice President, Head of BioPharma Development, Astellas "We are delighted the initial assessment of the DAYLIGHT study further validates the role of fezolinetant in reducing the frequency of moderate to severe VMS due to menopause. These 24-week placebo-controlled data add to our growing base of clinical evidence established in the SKYLIGHT studies and provide additional insights on the safety and effectiveness of fezolinetant in women who cannot or choose not to take hormone therapy." Fezolinetant was approved as VEOZAH™ by the U.S. Food and Drug Administration (FDA) in May 2023, and Astellas is pursuing regulatory approval for fezolinetant in several other countries and regions, including Europe. The DAYLIGHT study generated additional efficacy and safety data to primarily support health technology assessment (HTA) and reimbursement dossiers throughout Europe. Astellas has already reflected the impact from this result in its financial forecast of the current fiscal year ending March 31, 2024. About DAYLIGHT DAYLIGHT (NCT05033886) is a Phase 3b, randomized, double-blind, placebo-controlled, 24-week study to assess the efficacy and safety of fezolinetant in menopausal women aged 40-65 suffering from moderate to severe VMS and considered unsuitable for hormone therapy. A total of 453 women were enrolled at 69 sites in Canada, Europe and Turkey. About the BRIGHT SKY™ Phase 3 Program The BRIGHT SKY pivotal trials, SKYLIGHT 1™ (NCT04003155) and SKYLIGHT 2™ (NCT04003142), enrolled over 1,000 women with moderate to severe VMS. The trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. Women were enrolled at over 180 sites within the U.S., Canada and Europe. SKYLIGHT 4™ (NCT04003389) is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within the U.S., Canada and Europe. About Fezolinetant Fezolinetant is a neurokinin 3 (NK3) receptor antagonist FDA approved in the U.S. for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. Fezolinetant is not a hormone. 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"). Fezolinetant 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. 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. 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 Utian WH. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Health Qual Life Outcomes. 2005;3:47. 2 Jones RE, Lopez KH, eds. Human Reproductive Biology. 4th ed. Waltham, MA: Elsevier, 2014:120. SOURCE Astellas Pharma Inc.

VEOZAH is first-in-class treatment option to reduce the frequency and severity of moderate to severe VMS due to menopause TOKYO, May 12, 2023 /PRNewswire/ -- Astellas Pharma US, Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has approved VEOZAHTM (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause1 on May 12. VEOZAH is the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat VMS due to menopause. Check back soon for the Full Interactive Multimedia news release: VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.2,3 VMS are the most common symptoms of menopause for which women seek treatment.4 In the U.S., about 60% to 80% of women experience these symptoms during or after the menopausal transition.5,6,7 VMS can have a disruptive impact on women's daily activities and overall quality of life.2 "Today's approval of fezolinetant is a significant and, I believe, long awaited milestone for individuals in the U.S. who experience moderate to severe vasomotor symptoms during the menopausal transition," said Genevieve Neal-Perry, M.D., Ph.D., Chair, UNC School of Medicine Department of Obstetrics and Gynecology. "This therapy is based on our understanding of the biology behind hot flashes. I'm excited to know that patients will have the option to choose this nonhormonal treatment." Before menopause, there is a balance between estrogens (hormones made by a woman's ovaries) and neurokinin B (NKB), a brain chemical. This balance regulates the body's temperature control center located in a specific area of the brain. As the body goes through menopause, estrogens decline and this balance is disrupted. This imbalance can lead to very uncomfortable symptoms called VMS. VEOZAH helps to restore the balance by blocking NKB in the temperature control center to reduce the number and intensity of hot flashes. "VEOZAH uses a novel mechanism of action to target the root cause of VMS due to menopause," said Marci English, Vice President and Head of BioPharma Development, Astellas. "FDA approval of this new treatment for moderate to severe VMS due to menopause is a testament to Astellas' commitment to delivering innovative therapies in areas of unmet need that have been underserved, including women's health." The approval is supported by results from the BRIGHT SKY™ program, which included three Phase 3 clinical trials as part of a development program that collectively enrolled over 3,000 individuals across the U.S., Canada and Europe. Results from the SKYLIGHT 1™ and SKYLIGHT 2™ pivotal trials characterize the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS due to menopause. Data from the SKYLIGHT 4™ safety study further characterizes the long-term safety pro fezolinetant. Marketing authorization applications for fezolinetant are also under regulatory review in the EU, Switzerland and Australia. Astellas has already reflected the impact from this approval in its financial forecast of the current fiscal year ending March 31, 2024. For more information, please see the press release "U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant" issued on August 18, 2022 and the press release "Astellas Provides Update on Fezolinetant New Drug Application in U.S." issued on February 20, 2023. About VEOZAH (fezolinetant) VEOZAH (fezolinetant) is a neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. VEOZAH is not a hormone. 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"). 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. Important Safety Information Who should not take VEOZAH? 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. What should I tell my healthcare provider before taking VEOZAH? 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) 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 the BRIGHT SKY™ Phase 3 Program The BRIGHT SKY pivotal trials, SKYLIGHT 1™ (NCT04003155) and SKYLIGHT 2™ (NCT04003142), enrolled over 1,000 women with moderate to severe VMS. The trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. Women were enrolled at over 180 sites within the U.S., Canada and Europe. SKYLIGHT 4™ (NCT04003389) is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within the U.S., Canada and Europe. 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 VEOZAH package insert. Northbrook, IL: Astellas Inc. 2 Utian WH. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Health Qual Life Outcomes. 2005;3:47. 3 Jones RE, Lopez KH, eds. Human Reproductive Biology. 4th ed. Waltham, MA: Elsevier, 2014:120. 4 Williams RE, Kalilani L, DiBenedetti DB, et al. Healthcare seeking and treatment for menopausal symptoms in the United States. Maturitas. 2007;58:348-358. 5 Gold EB, Colvin A, Avis N, et al. Longitudinal analysis of the association between vasomotor symptoms and race/ethnicity across the menopausal transition: study of women's health across the nation. Am J Public Health. 2006;96:1226-1235. 6 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;21:924-932. 7 Williams RE, Kalilani L, DiBenedetti DB, et al. Frequency and severity of vasomotor symptoms among peri- and postmenopausal women in the United States. Climacteric. 2008;11:32-43. Company Codes: Tokyo:4503, OTC-PINK:ALPMY

Synthesized Kappa Opioid Receptors (KOP) Appear to be Devoid of Many Problematic Mu Receptor Side-effects Such as Tolerance, Addiction, Sedation, and Euphoria/Dysphoria, KOP Peptides Showed Significant Opioid-like Antinociception Comparable to Morphine and U50844H PreveCeutical's Pain Management Peptides Program Published in the Swiss Medical Journal. Vancouver, British Columbia--(News - April 4, 2023) - PreveCeutical Medical Inc. (CSE: PREV) (OTCQB: PRVCF) (FSE: 18H) (the "Company" or "PreveCeutical") is pleased to announce the full independent peer-reviewed publication of an article on the design and development of its non-addictive analgesic program ("Analgesic Program"). The article entitled, "Design and development of novel, short, stable dynorphin-based opioid agonists for safer analgesic therapy," was published in Frontiers Media SA (the "Frontiers") and can be found here. The article is published under the journal's open-access scheme. The Analgesic Program was initiated in July 2018 and was designed to discover and develop peptide-based therapeutics for moderate to severe pain. The program was successfully completed in March 2021, and in March 2023, PreveCeutical began preparation with a world-leading CRO to advance the Analgesic Program into Phase 1 clinical trials. The class of compounds, peripheral Kappa opioid receptor (KOPr) agonists, are considered potential analgesics without the dose-limiting central nervous system-mediated side effects. The potency and duration of action of peptides identified in the study were comparable to the clinical standard morphine, in-vivo. PreveCeutical's Chair and Chief Executive Officer, Mr. Stephen Van Deventer, stated, "Having an independent peer-reviewed article from PreveCeutical's program and having it published in the prestigious Frontiers is a big milestone for our non-addictive analgesic program. Therapies based on these potentially non-addictive peptides will be important in addressing the current opioid crisis." Frontiers is the leading international general pharmacology journal representing the 3rd most-cited and 6th largest open science research platform publisher. It publishes high-quality original research and authoritative reviews, addresses topical pharmacology issues, and is committed to transparency and scientific rigour. About PreveCeutical PreveCeutical is a health sciences company that develops innovative options for preventive and curative therapies utilizing organic and nature identical products. The Company aims to be a leader in the preventive health sciences sector. With the completion of three of its research programs, the Company is actively working on the development, clinical trials, and commercialization of its products; and has filed a number of provisional patent applications to protect the intellectual property from its research programs. The Company is currently in the research and development stage for dual gene curative and preventive therapies for diabetes and obesity. For more information about PreveCeutical, please visit our website, or follow us on Twitter and Facebook. On behalf of the Board of Directors of PreveCeutical Stephen Van Deventer, Chairman and Chief Executive Officer For further information, please contact: Stephen Van Deventer: +1 604 306 9669 Or Investor Relations ir@preveceutical.com Forward-Looking Statements: This news release contains forward-looking statements and forward-looking information (collectively, "forward-looking statements") within the meaning of applicable Canadian and U.S. securities legislation, including the United States Private Securities Litigation Reform Act of 1995. All statements in this news release that are not purely historical are forward-looking statements and include statements regarding beliefs, plans, expectations and orientations regarding the future, including, without limitation, matters related to the Company's current and planned research and development programs, including the Analgesic Program, the Company's anticipated business plans and its prospect of success in executing its proposed plans. Often, but not always, forward-looking statements can be identified by words such as "will", "plans", "expects", "may", "intends", "anticipates", "believes", "proposes", or variations of such words including negative variations thereof and phrases that refer to certain actions, events or results that may, could, would, might or will occur or be taken or achieved. Forward-looking statements are based on certain assumptions regarding the Company, including expected growth, results of operations, including the Company's research and development activities, performance, industry trends, growth opportunities, and that the Company will be able to obtain the financing required to carry out its planned future activities, retain and attract qualified research personnel and obtain and/or maintain the necessary intellectual property rights it needs to carry out its future business activities. Actual results could differ from those projected in any forward-looking statements due to numerous factors including, risks and uncertainties relating to the Analgesic Program, complexities and delays in connection with research and development activities and the actual results of research and development activities, and the inability of the Company, to, among other things, obtain any required governmental, regulatory or stock exchange approvals, permits, consents or authorizations required, including Canadian Securities Exchange acceptance of any planned future activities, commercialize therapeutic and diagnostic technologies, execute its proposed business plans, pursue business partnerships, complete its research and product development programs as planned, including the Analgesic Program, and obtain the financing required to carry out its planned future activities. Other factors such as general economic, market or business conditions or changes in laws, regulations and policies affecting the healthcare and cannabis industries in Canada may also adversely affect the future results or performance of the Company. These forward-looking statements are made as of the date of this news release and, unless required by applicable law, the Company assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in these forward-looking statements. Although the Company believes that the statements, beliefs, plans, expectations, intentions, and assumptions contained in this news release are reasonable, there can be no assurance that those statements, beliefs, plans, expectations, intentions, or assumptions will prove to be accurate. Readers should consider all of the information set forth herein and should also refer to other periodic reports provided by the Company from time-to-time. These reports and the Company's filings are available at . Readers are cautioned that forward-looking statements are not guarantees of future performance or events and, accordingly, are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty of such statements. To view the source version of this press release, please visit