Hypertension, Pregnancy-Induced

Chaired by founder Stephen Birrell, MD PhD, group includes experts in breast cancer biology, endocrine signaling and biomarker-driven risk reduction strategies BOULDER, Colo.--(BUSINESS WIRE)--Havah Therapeutics, a clinical stage biopharmaceutical company developing innovative, proprietary hormonal implant therapies for prevention and treatment of breast cancers, announced the formation of their Clinical Advisory Board Chaired by Havah Therapeutics founder Stephen Birrell, MD, PhD. “The scientific and clinical guidance of this esteemed group will be invaluable as we advance our androgen targeted therapy into late-stage clinical studies for Ductal Carcinoma In-Situ (DCIS) and investigator-sponsored combination studies in more advanced disease,” said, Matthew Brewer, CEO of Havah Therapeutics. Shelley Hwang, MD, MPH, Breast Cancer Research Foundation (BCRF) Investigator and internationally recognized expert in pre-invasive disease and DCIS, added: “I am thrilled to be involved with Havah Therapeutics at this critical stage of their development. Insights gained from their ongoing Phase 2 study ( RECAST DCIS ), coupled with my experience as the principal investigator of the COMET Study , will potentially enable the company’s androgen receptor targeting therapy to provide a much needed treatment alternative to invasive surgery and radiation treatment.” The members of Havah Therapeutics’ Clinical Advisory Board include: Stephen Birrell, MD, PhD (Chair), is founder of Havah Therapeutics and Chief Medical Officer of Wellend Health, an Australia-wide clinic that specializes in breast hormone-health, women at high-risk breast cancer and clinical trials. He is a Clinical Affiliate academic at the University of Adelaide Dame Roma Mitchell Cancer Research Laboratories. Shelley Hwang, MD, MPH is the Mary and Deryl Hart Distinguished Professor of Surgical Oncology and Radiology, Vice Chair of Research and Disease Group Leader for the Breast Cancer Program at Duke University Comprehensive Cancer Center. Her research focus includes breast cancer prevention, identifying less invasive treatments for early-stage breast cancers including DCIS and addressing and mitigating health care disparities in breast cancer. Seema A. Khan, MD is Professor of Surgery in the Feinberg School of Medicine at Northwestern University, and the Bluhm Family Professor of Cancer Research. She is the Co-Leader of the Cancer Prevention Research Program at the Robert H. Lurie Comprehensive Cancer Center. Her research focuses on applying biomarker knowledge to improve breast cancer risk stratification and develop preventive interventions for high-risk women. Her research is funded by the National Institutes of Health, The Breast Cancer Research Foundation, the Avon Foundation, and the Susan G. Komen Foundation Professor Wayne Tilley, PhD is the Inaugural Director of the Dame Roma Mitchell Cancer Research Laboratories, University of Adelaide. He completed a Fellowship at UT Southwestern in Dallas Texas in the late 1980s where he was one of the first to clone the human androgen receptor (AR) with Professor Jean Wilson, MD. A current major research focus of Professor Tilley’s lab is the development of new treatments for breast cancer that stimulate the tumor suppressive activity of the AR in the breast (Nature Medicine 2021; Lancet Oncology 2024) to counter the proliferative effects of estrogen. Additional background information on the CAB members can be found on the company’s website: About RECAST DCIS Havah Therapeutics is currently participating in the Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: Ductal Carcinoma In Situ (RECAST DCIS), a Phase 2 platform study aimed at preventing the progression of DCIS to breast cancer. Havah Therapeutics’ HAVAH T+Ai™, a proprietary combination of testosterone (T) and anastrozole (Ai) that targets the androgen and estrogen receptor pathways, is being evaluated alongside two other endocrine therapy arms. About Havah Therapeutics Havah Therapeutics is developing a novel therapeutic implant for treating hormonally sensitive cancers and other breast conditions. This groundbreaking method relies on stimulating (agonizing) the androgen receptor in breast tissue, utilizing natural hormonal mechanisms to treat patients safely and with greatly reduced side effects. The product is a combination of two registered agents (testosterone and anastrozole, a low dose aromatase inhibitor) that when dosed, provides three months of continuous medication enabling a superior product pro compliance, safety and efficacy. For more information, visit . Contacts Media Contacts: Matthew Brewer mb@havahtx.com Danielle Clark-Brown dcb@havahtx.com

EVANSTON, Ill., Oct. 23, 2024 /PRNewswire/ -- During National Massage Therapy Awareness Week®, the American Massage Therapy Association (AMTA) is sharing a recent wave of research highlighting the benefits of massage therapy throughout pregnancy and labor. These studies demonstrate how massage therapy can reduce pain, ease insomnia, improve mental health, and enhance overall comfort during pregnancy and childbirth. Collectively, these findings suggest that massage therapy is a promising, non-pharmacological option for reducing symptoms during pregnancy and labor. Continue Reading Research indicates that massage can reduce pain, ease insomnia, and improve mental health during pregnancy and labor. Post this Massage therapy is a promising, non-pharmacological option for reducing troubling symptoms in pregnant women. "The growing body of research continues to reveal the many benefits of massage therapy during pregnancy and labor," said Kim Kane-Santos, AMTA National President. "As part of an integrative approach to care, massage serves as a valuable non-invasive tool to help manage troubling symptoms during these critical stages." Massage Therapy Reduces Pain and Anxiety During Labor In a recent randomized clinical trial, researchers aimed to determine the most effective cervical dilation stage for applying massage therapy to reduce labor pain and anxiety. Sixty women in active labor were randomly assigned to either a massage group or a control group. The massage group received three 20-minute massages at 5, 7, and 9 cm of cervical dilation, while the control group received standard care without massage. Pain intensity was measured using a pain ruler, and anxiety levels were assessed through questionnaires. The findings indicated that massage therapy significantly reduced pain at 7 cm dilation. Additionally, anxiety levels in the massage group decreased from severe to moderate, while the control group saw a slight increase in anxiety.1 Massage Eases Insomnia and Anxiety in Preeclamptic Pregnant Women A 2024 study investigated the effects of classical foot massage on insomnia and anxiety levels in preeclamptic pregnant women. Preeclampsia is a serious condition of pregnancy, usually characterized by high blood pressure and severe swelling. This study included seventy-one participants divided into an experimental group receiving foot massages three days a week and a control group receiving no interventions. Results indicated a significant reduction in insomnia and anxiety levels in the experimental group compared to the control group. The findings suggest that classical foot massage can be an effective intervention for alleviating insomnia and anxiety symptoms in preeclamptic pregnant women. Massage Shows Promise in Improving Mental Health Symptoms in Pregnancy Roughly 20 percent of pregnant women experience clinically significant anxiety and/or depression. A recent systematic review and meta-analysis examined the effectiveness of massage therapy in decreasing anxiety and depression among pregnant women. Eight studies, including seven randomized controlled trials, were analyzed. Findings showed that massage reduced depressive symptoms and anxiety compared to usual care. These findings highlight the potential of massage therapy as a non-pharmacological treatment for mental health symptoms during pregnancy.3 About The American Massage Therapy Association The American Massage Therapy Association, the most trusted name in massage therapy, is a non-profit and the largest professional association serving massage therapists, massage students and massage schools. The association is directed by volunteer leadership and fosters ongoing, direct member-involvement through its 51 chapters. AMTA works to advance the profession through ethics and standards, the promotion of fair and consistent licensing of massage therapists in all states, and public education on the benefits of massage. To find a qualified massage therapist in your area, please visit AMTA's Find a Massage Therapist Locator Service™. Research Citations Shahbazzadegan S, Nikjou R. "The most appropriate cervical dilation for massage to reduce labor pain and anxiety: a randomized clinical trial." BMC Womens Health. 2022 Jul 7;22(1):282 Ayca Solt Kirca, Nurdilan Sener Cetin."The effect of classical foot massage on insomnia and anxiety in preeclamptic pregnant women: a randomized controlled study." 2024 Feb 26;70(2):e20230744. Hall HG, Cant R, Munk N, Carr B, Tremayne A, Weller C, Fogarty S, Lauche R. "The effectiveness of massage for reducing pregnant women's anxiety and depression; systematic review and meta-analysis." 2020 Aug 14;10.1016/j.midw.2020.102818. Media Contact: [email protected] SOURCE American Massage Therapy Association WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

US FLUBLOK label1 updated to incorporate new safety study in pregnant individuals New safety data involving more than 48,000 pregnant individuals published in American Journal of Obstetrics and Gynecology (AJOG) Global Reports Recombinant or inactivated flu vaccines are recommended by the U.S. Centers for Disease Control and Protection (CDC), Advisory Committee on Immunization Practices (ACIP) and American College of Obstetricians and Gynecologists (ACOG) for individuals who are or will become pregnant during flu season2,3,4 Sanofi is committed to the ongoing rigorous scientific study of flu vaccines in at-risk populations, including older patients, patients with comorbidities and pregnant individuals BRIDGEWATER, N.J., Oct. 16, 2024 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has updated the label for FLUBLOK (Influenza Vaccine) to include data from a new safety study involving pregnant individuals 18 years and older, in time to inform those hoping to comply with U.S. Centers for Disease Control and Prevention (CDC) recommendations to receive their annual flu vaccine ideally before the end of October.4,5 The results from the study of more than 48,000 pregnant individuals across multiple flu seasons were recently published in American Journal of Obstetricians and Gynecologists (AJOG) Global Reports and demonstrate FLUBLOK safety is consistent with a standard-dose flu vaccine and pregnancy-related outcomes in the general population.1,5 Thomas Grenier Head of Vaccines, North America, Sanofi "Today, we're proud to announce an important update to our label for FLUBLOK, from one of Sanofi's largest flu vaccine safety studies ever done in pregnant individuals, an important at-risk population group for influenza. Here at Sanofi, we strive to bring immunizations to populations at various stages of life. This update is an example of our ambition to continue expanding the body of real-world evidence for our flu vaccines portfolio, grounded in robust efficacy data. We do this so that patients and healthcare providers can have the confidence to use our vaccines as an important preventative tool ahead of the influenza season." This study was a post-licensure, observational, retrospective safety surveillance study of 48,781 pregnant individuals, including those with chronic conditions.1 In the study, patients were immunized with either FLUBLOK Quadrivalent (30.7%; n=14,981) or with a comparator standard-dose quadrivalent inactivated influenza vaccine (67.3%; n=33,800) during the Northern Hemisphere influenza seasons 2018-2019 and 2019-2020.1 Immunization occurred within 28 days prior to pregnancy or during pregnancy.1 The efficacy of FLUBLOK (quadrivalent) is relevant to FLUBLOK (trivalent) because both vaccines are manufactured using the same process and have overlapping compositions.5 Results showed: FLUBLOK demonstrated no increased risk of pregnancy, birth or neonatal/infant outcomes when compared to a standard-dose flu vaccine and estimated pregnancy outcomes for the general population.1 The most frequently reported pregnancy outcomes in the FLUBLOK Quadrivalent and SD-IIV4 groups respectively were eclampsia/preeclampsia (8.4% in both cohorts), preterm labor (3.6% and 3.5%), spontaneous abortion (3.1% and 3.0%), congenital/fetal anomalies detected during pregnancy (2.4% in both cohorts), placental abruption (0.8% and 0.7%) and stillbirth/fetal death (0.4% and 0.5%).1 The most frequently reported birth and neonatal/infant outcomes in the FLUBLOK Quadrivalent and SD-IIV4 groups were small for gestational age (SGA) (8.8% and 8.7%), major congenital anomalies (7.7% in both cohorts), preterm birth (7.3% and 7.5%), low birth weight (LBW) (5.9% and 5.8%) and failure to thrive (1.0% and 1.1%), respectively.1 Per the CDC, pregnant and postpartum (up to two weeks after the end of pregnancy) individuals are at higher risk for severe illness and complications from flu, particularly during the second and third trimesters.4 The American College of Obstetricians and Gynecologists (ACOG) recommends full vaccination during pregnancy, as this is when the risk of severe illness is highest.3,4 The CDC, Advisory Committee on Immunization Practices (ACIP) and ACOG recommend that individuals who are or will become pregnant during flu season receive an inactivated or recombinant vaccine as soon as it is available, as pregnant persons with influenza may be at increased risk for adverse pregnancy outcomes, including preterm labor and delivery.2,3,4 With over 125 years of heritage in helping protect global public health, Sanofi is one of the world leaders in vaccines, helping to vaccinate more than 500 million people annually. As one of the largest providers of influenza vaccines to the United States with a wide range of options, Sanofi meets immunization needs across the lifespan, from children as young as six months of age through adults 65 years of age and older. Indication and Important Safety Information for FLUBLOK (Influenza Vaccine) What is FLUBLOK (Influenza Vaccine)? FLUBLOK is a vaccine indicated for immunization for the prevention of disease caused by influenza A and B strains represented by antigens contained in the vaccine. FLUBLOK is given to people 18 years of age and older. IMPORTANT SAFETY INFORMATION FOR FLUBLOK® (INFLUENZA VACCINE) FLUBLOK should not be given to anyone who has had a severe allergic reaction to any component of the vaccine. Tell your health care provider if you have ever had Guillain-Barré syndrome (severe muscle weakness) after a previous influenza vaccination. If FLUBLOK is given to people with a compromised immune system, including those receiving therapies that suppress the immune system, the immune response may be lower than expected. Vaccination with FLUBLOK may not protect all people who receive the vaccine. Fainting has occurred following vaccination with FLUBLOK. Procedures should be in place to avoid injury from fainting. In adults 18 through 64 years of age, the most common side effects were pain where you got the shot, headache, tiredness, and muscle pain. In adults 65 years of age and older, the most common side effects were pain where you got the shot, tiredness and headache. Other side effects may occur. For more information, talk to your health care professional and refer to the full Prescribing Information for Flublok. About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN andNASDAQ: SNY. Contacts Sandrine Guendoul | + 33 6 25 09 14 25 | [email protected] Evan Berland | +1 215 432 0234 | [email protected] Timothy Gilbert | + 1 516 521 2929 | [email protected] Investor Relations Thomas Kudsk Larsen | +44 7545 513 693 | [email protected] Alizé Kaisserian | + 33 6 47 04 12 11 | [email protected] Arnaud Delépine | + 33 6 73 69 36 93 | [email protected] Felix Lauscher | + 1 908 612 7239 | [email protected] Keita Browne | + 1 781 249 1766 | [email protected] Nathalie Pham | + 33 7 85 93 30 17 | [email protected] Tarik Elgoutni| + 1 617 710 3587 | [email protected] Thibaud Châtelet | + 33 6 80 80 89 90 | [email protected] Sanofi Forward-Looking Statements This media update contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. All trademarks mentioned in this press release are the property of the Sanofi group. 1 HSIAO, A., YEE, A., IZIKSON, R., FIREMAN, B., HANSEN, J., LEWIS, N., … KLEIN, N. P. (2024). Safety of quadrivalent recombinant influenza vaccine in pregnant persons and their infants. AJOG Global Reports, 100395. . 2 Centers for Disease Control and Prevention. Flu Vaccine Safety and Pregnancy. Available at: . Accessed October 2024. 3 The American College of Obstetricians and Gynecologists. Influenza in Pregnancy: Prevention and Treatment. Available at: . Accessed October 2024. 4 Centers for Disease Control and Prevention. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices – United States, 2024-25 Influenza Season. Available at: . Accessed October 2024. 5 Flublok [Prescribing Information]. Swiftwater, PA: Sanofi. SOURCE Sanofi WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED