Bayer HealthCare

WHIPPANY, N.J.--( BUSINESS WIRE )--In honor of Women’s Health Month, Bayer is putting a national spotlight on the impact of the underdiscussed and underdiagnosed condition of heavy menstrual bleeding (HMB) and that Mirena ® (levonorgestrel-releasing intrauterine system) 52 mg is an FDA-approved IUD to treat heavy periods for up to 5 years in women who choose an IUD for birth control. 2 With its new multi-channel campaign Seeing Red , Bayer aims to raise awareness of HMB and a potential treatment option. Seeing Red encourages women across America to talk to their healthcare provider about their heavy periods and discuss if Mirena could be right for them. 1 in 3 women who have periods experience HMB. While it may be difficult for women to determine exactly what a heavy period is because everyone is different, women who experience HMB may lose 1/3 cup of blood or more during their period. Symptoms may include needing to double up on pads or having to change pads or tampons during the night. Despite its effect and common incidence, many women are unaware that HMB is a medical condition, or that there may be treatment options available as some have been inaccurately told or believe their heavy periods are normal. This leaves many women putting up with HMB symptoms for years before realizing they can talk to their doctor about helping to find a treatment option that might be right for them. 1 In the clinical trial of Mirena in women with HMB, almost 9 out of 10 were treated successfully, seeing improvement in symptoms after six months. The majority of women experienced an 80% reduction in bleeding after three months and more than 90% reduction in bleeding after six months. 1 The number of spotting and bleeding days may initially increase but then typically decrease in the months that follow. Bleeding may also continue to be irregular. 2 “Bayer Women’s Healthcare is committed to the reproductive health of women, and we work hard to help ensure that every woman can feel informed when it comes to her reproductive decisions and health,” said John Berrios, Senior Vice President, General Manager of Women’s Healthcare, Bayer. “We believe that every woman should have access to what she needs, with the power to choose what’s best for her own body and journey. Through our Seeing Red campaign, we want to elevate the importance of effective contraception and a potential treatment option for heavy menstrual bleeding.” The Seeing Red campaign is a national, multi-channel media campaign featuring a commercial shedding light on a contraceptive and HMB treatment option, partnerships with healthcare provider and patient influencers, and social and digital content with Betches Media. For over 60 years, Bayer has been a leader in advancing women’s health across the globe, so all women can determine their own future. The company’s legacy includes innovations that have shaped and defined the women’s healthcare landscape, from launching the first birth control pill in 1961 to Mirena, the #1 prescribed IUD in the U.S. 1 Bayer encourages women to talk to their healthcare provider to determine if Mirena is right for them. To learn more about the campaign and about a birth control that may also help with HMB, visit Mirena.com . About Mirena INDICATIONS FOR MIRENA Mirena ® (levonorgestrel-releasing intrauterine system) is a hormone-releasing IUD that prevents pregnancy for up to 8 years. Mirena also treats heavy periods for up to 5 years in women who choose intrauterine contraception. IMPORTANT SAFETY INFORMATION If you have a pelvic or genital infection, get infections easily, or have certain cancers, don't use Mirena. Less than 1% of users get a serious pelvic infection called pelvic inflammatory disease (PID). If you have persistent pelvic or stomach pain, or excessive bleeding after placement, tell your healthcare provider (HCP). If Mirena comes out, call your HCP and avoid intercourse or use non-hormonal back-up birth control (such as condoms or spermicide). Mirena may go into or through the wall of the uterus and cause other problems. Pregnancy while using Mirena is uncommon but can be life threatening and may result in loss of pregnancy or fertility. Ovarian cysts may occur but usually disappear. Bleeding and spotting may increase in the first 3 to 6 months and remain irregular. Periods over time usually become shorter, lighter, or may stop. Mirena does not protect against HIV or STIs. Only you and your HCP can decide if Mirena is right for you. Mirena is available by prescription only. For important risk and use information about Mirena, please see Full Prescribing Information. About Women’s Healthcare at Bayer Bayer is a recognized leader in the area of women’s healthcare, with 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. Today, Bayer’s research and development efforts focus on finding new treatment options for menopause as well as gynecological diseases and includes several compounds in various stages of pre-clinical and clinical development. Together, these projects reflect the company’s approach to research, which prioritizes targets and pathways with the potential to alter the way that gynecological diseases are treated. Additionally, Bayer intends to provide 100 million women 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 www.bayer.com. 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 www.bayer.com . The company assumes no liability whatsoever to update these forward-looking statements or to confirm them to future events or developments. References Learn about Mirena® IUD. Homepage. (n.d.). Retrieved March 30, 2023, from https://www.mirena-us.com/ Bayer. Mirena Prescribing Information

There was bad news for Bayer yesterday (Thursday) after the US Food and Drug Administration turned down an additional indication for its Johnson & Johnson-partnered blood thinner Xarelto. The regulator has issued a complete response letter outlining its objections to approving the drug at this time, though specifics have not been revealed by either company. The move comes on the back of an assessment by an advisory committee earlier this month, which voted narrowly against recommending the Xarelto (rivaroxaban), in combination with standard antiplatelet therapy, to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS). Committee members expressed serious concerns about the increased risk of major and fatal bleeding associated with the drug, and that 15% of participants enrolled in the 1,500-patient ACS study dropped out of the trial. The companies, however, remain committed to securing an approval for the drug in this setting. "We are confident of the safety and efficacy of rivaroxaban in this indication and will work closely with our development partner Janssen Research & Development, LLC, to address the questions set forth by the FDA," said Kemal Malik, Member of the Bayer HealthCare Executive Committee and Head of Global Development. Xarelto has already racked up three approvals in the US: to reduce the risk of blood clots in the legs and lungs of people who have undergone knee replacement surgery; to reduce this risk hip replacement surgery patients; and to cut the risk of both haemorrhagic and thrombotic strokes (and other blood clots) in people with atrial fibrillation not caused by a heart valve problem. Bayer has previously said it is expecting peak sales of more than 2 billion euros a year for Xarelto if all goes to plan.

WAYNE, N.J., Feb. 4, 2011 /PRNewswire/ — Bayer HealthCare Pharmaceuticals Inc. announced today that its investigational compound regorafenib (BAY 73-4506) has been granted orphan drug status for the treatment of patients with gastrointestinal stromal tumors (GIST) by the U.S. Food and Drug Administration (FDA). Regorafenib is an investigational agent and is not approved by the FDA, the European Medicines Agency (EMA) or other Health Authorities. “This is an important step in the overall development process for this investigational compound,” said Kemal Malik, MD, Head of Global Development and member of the Bayer HealthCare Executive Committee. In January, Bayer began enrolling patients in a randomized, double-blind, placebo-controlled Phase III study of regorafenib plus best supportive care versus placebo plus best supportive care for subjects with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib (NCT01271712). The trial is estimated to enroll 170 patients, who will be randomized in a 2:1 ratio to receive either regorafenib or placebo. Subjects receiving placebo who experience disease progression may be offered open-label regorafenib treatment (cross-over option). The primary endpoint of this trial is progression-free survival (PFS), and secondary endpoints include overall survival (OS), time to progression (TTP), disease control rate (DCR), tumor response rate (RR), duration of response (DOR), and safety. All patients will enter the Survival Follow-Up Period upon discontinuation of study treatment, during which assessment of survival status will be performed every three months. For information about this study, please visit www.clinicaltrials.gov (NCT01271712). Orphan Drug Designation in the United States In the United States, the Orphan Drugs Act (OD ‘/>”/> SOURCE