Bayer Pharmaceuticals

BERLIN, Germany I October 09, 2024 I Bayer today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for the investigational compound elinzanetant seeking approval for the treatment of moderate-to-severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause. “The NDA acceptance of elinzanetant by the FDA marks a significant milestone in our efforts to advance menopause care for women in the U.S.,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, Member of the Pharmaceutical Leadership Team at Bayer.“If approved, elinzanetant will offer a new non-hormonal option to women seeking treatment for moderate to severe vasomotor symptoms and we look forward to the review by the agency.” The NDA application is based on the positive results from the OASIS 1, 2 and 3 Phase III studies evaluating the efficacy and safety of the investigational compound elinzanetant versus placebo. Findings from OASIS 1 and 2 were published in August 2024 in JAMA . 1 Detailed results of the Phase III study OASIS 3 providing supporting efficacy and additional long-term safety data were presented at The Menopause Society (TMS) annual meeting in September 2024. Bayer is continuing to submit applications for marketing authorizations of elinzanetant to further health authorities as well. About the Elinzanetant clinical development program The Phase III clinical development program of elinzanetant, OASIS, currently comprises four Phase III studies: OASIS 1, 2, 3 and 4. OASIS 1 and 2 investigated the efficacy and safety of elinzanetant administered orally once daily in women with moderate to severe VMS associated with menopause over 26 weeks and randomized 396 and 400 postmenopausal women between 40 and 65 years across 184 sites in 15 countries. Patients in the elinzanetant arm received a 120 mg dose of elinzanetant once daily for 26 weeks and patients in the control arm received a matching placebo once daily for 12 weeks, followed by elinzanetant 120 mg dose for 14 weeks. OASIS 3 investigated the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms over 52 weeks in postmenopausal women and randomized 628 postmenopausal women between 40 and 65 years across 83 sites in 9 countries. 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. In addition to the OASIS program, Bayer is conducting NIRVANA (NCT06112756), 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 further evaluating the safety of elinzanetant. About Elinzanetant Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 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. Based on key secondary endpoints of OASIS 1 and 2, Elinzanetant may also decrease sleep disturbances associated with menopause. About Vasomotor Symptoms Vasomotor symptoms (VMS; also referred to as hot flashes) result from hyperactivation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons. This is due to a decrease of estrogen, which can result from the progressive reduction of ovarian function due to natural menopause or medical intervention by bilateral oophorectomy or endocrine therapy. VMS are reported by up to 80% of women at some point during the menopausal transition and are one of the leading causes for seeking medical attention during this phase of a woman’s life. Over one-third of menopausal women report severe symptoms, which can last 10 years or more after the last menstrual period, with relevant impact on quality of life. VMS may also be caused by endocrine therapy, for the treatment or prevention of breast cancer, impacting quality of life and treatment adherence. For these women, there are currently no approved treatment options. About Menopause By 2030, the global population of women experiencing menopause is projected to increase to 1.2 billion, with 47 million women entering this phase each year. Menopause is a transitional phase in women’s lives, related to the progressive decline of ovarian function. It usually occurs in women during their 40s or early 50s. It can also be the result of surgical or medical treatment such as 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. 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 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 for capacity building 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. In line with its mission, “Health for all, Hunger for none,” the company’s 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 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com . Find more information at https://pharma.bayer.com/ Follow us on Facebook: http://www.facebook.com/bayer Follow us on LinkedIn: Bayer | Pharmaceuticals 1 https://jamanetwork-com.libproxy1.nus.edu.sg/journals/jama/fullarticle/2822766 SOURCE: Bayer

The partnership aims to leverage both companies’ expertise in gene therapy technology. Credit: illustrissima/Shutterstock. Asklepios BioPharmaceutical (AskBio), a subsidiary of Bayer , has entered a strategic partnership with China-based Belief BioMed (BBM) to advance the development of new gene therapies. The partnership aims to leverage both companies’ expertise in gene therapy technology, particularly for conditions that can be treated through a liver-targeted approach. Using viral vector technology, BBM unifies the development, production and clinical usage of experimental gene therapy products for severe hereditary and chronic illnesses. The business has created advanced vector technology and set up a platform for the commercial manufacture of gene therapy medications in China. AskBio chief scientific officer Mansuo Shannon stated: “AskBio takes a collaborative approach when developing new gene therapies, and we look worldwide to use the most promising science to realise our goals. See Also: Biologic API Manufacturing Companies (Protein and Peptide) in Contract Manufacturing for the Pharmaceutical Industry Bavarian Nordic gains US contract for additional mpox vaccine “The potential of BBM’s next-generation capsid technology, together with the work we are conducting at AskBio, is promising. We are looking forward to working closely with the team at BBM.” Belief BioMed’s new drug application for a haemophilia B treatment was accepted by the China National Medical Products Administration in July 2024. This application is the first submitted in China for a gene therapy product for an inherited genetic disease. BBM has developed new engineered adeno-associated virus vectors. These products have demonstrated the potential to reduce immunogenicity and increase transduction efficiency in human and non-human trials. Bayer Pharmaceuticals business development and licensing head Juergen Eckhardt stated: “Gene therapy has some of the greatest potential in modern medicine, particularly from a technical perspective. “One path to success lies in collaborations such as this and in bringing together experts with broad expertise and experience. We are excited for AskBio’s new collaboration with BBM and the advancements it may one day bring to patients.” In January 2023, AskBio entered a research partnership and option agreement with ReCode Therapeutics to assess its single-vector gene-editing platform . Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Cell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Cytiva Thematic By downloading this Whitepaper, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy

Groups Develop Request for Proposals for Research Grants Focused on Lung Cancers Harboring HER2 Mutations and/or Other HER2 Alterations NEW YORK, Sept. 5, 2024 /PRNewswire/ -- The Lung Cancer Research Foundation (LCRF) is pleased to announce its collaboration with Bayer Pharmaceuticals to fund two research grants focused on innovative strategies to advance understanding and management of lung cancers harboring HER2 mutations and/or other HER2 alterations. This collaboration seeks to address important mechanistic questions and developmental therapeutics across the care continuum for HER2-mutant NSCLC, and has the potential to improve patient outcomes. "LCRF is delighted to collaborate with Bayer to identify and support outstanding lung cancer research projects that will help develop treatments for this specific set of lung cancers," says Kathryn O'Donnell, PhD, LCRF Scientific Advisory Board chair. "Expanding the treatment options available to patients affected by HER2 mutations or alterations is an important and exciting area in lung cancer research." "We are delighted to encourage and support groundbreaking research via this new LCRF initiative. This collaboration underscores our ongoing commitment to patients living with lung cancer, and our unwavering drive to advance precision oncology in disease areas with the highest unmet needs," said Abdelali Majdi, MD, Head of Global Medical Affairs Precision Oncology & Pipeline at Bayer's Pharmaceuticals Division. Lung cancer is responsible for more deaths worldwide than any other cancer, accounting for an estimated 130,180 deaths annually in the United States alone.1 Globally, there are approximately 1.8 million new cases of lung cancer every year and over 1.6 million deaths. 2 The last ten to fifteen years have seen accelerated clinical trials and regulatory approvals of targeted therapies for non-small cell lung cancer (NSCLC) in part due to advances in molecular profiling of tumors. Many of these targeted therapies are directed against oncogenic drivers. The HER family of tyrosine kinases include HER1 (epidermal growth factor receptor [EGFR] or ERBB1), HER2 (HER2/neu or ERBB2), HER3, and HER4. EGFR mutations were one of the first oncogenic drivers that were successfully targeted with the use of tyrosine kinase inhibitors. Despite substantial progress in this area, available treatments are generally not curative, and resistance invariably develops. Twenty years ago, HER2 mutations were also identified as potential oncogenic drivers in lung cancer. Activating mutations of HER2 (mostly exon 20 insertions, such as HER2 YVMA) occur in up to 4% of NSCLC. Until recently, developing effective HER2-targeted therapies for lung cancer has been a challenge. Immunotherapeutic strategies have not been successful in the treatment of lung cancers with genomic alterations such as HER2 mutations. It is of vital importance that there is a better understanding of the mechanism of tumor response and resistance. Moreover, given that therapeutic options available to date are not curative, there is a need for novel approaches to treat HER2-mutant lung cancers. The LCRF | Bayer Lung Cancer Research Award will focus on the science behind HER2 alterations as oncogenic drivers of malignancy and/or the development of novel therapeutic approaches for patients with tumors harboring HER2 mutations and/or other HER2 alterations. To be notified when the Request for Proposals is open for submissions, go to LCRF.org/HER2-RFP. To learn more about LCRF and its grants program, visit . About the Lung Cancer Research Foundation (LCRF) The Lung Cancer Research Foundation® (LCRF) is the leading nonprofit organization focused on funding innovative, high-reward research with the potential to extend survival and improve quality of life for people with lung cancer. LCRF's mission is to improve lung cancer outcomes by funding research for the prevention, diagnosis, treatment, and cure of lung cancer. To date, LCRF has funded 419 research grants, totaling nearly $44 million, the highest amount provided by a nonprofit organization dedicated to funding lung cancer research. For more information, visit lcrf.org. Contact: Sheila Sullivan Sr. Director, Marketing & Communications, LCRF [email protected] 1 American Cancer Society. Cancer Facts & Figures 2022. Atlanta: American Cancer Society; 2022 2 Babar L, Modi P, Anjum F. Lung Cancer Screening. [Updated 2023 Jul 24]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: Accessed: June 2024. SOURCE Lung Cancer Research Foundation