Relugolix/Estradiol/Norethindrone Acetate

MISSISSAUGA, ON and KIRKLAND, QC, Oct. 19, 2023 /PRNewswire/ -- Sumitomo Pharma Canada, Inc. and Pfizer Canada today announced that Health Canada has granted a Notice of Compliance (NOC) for MYFEMBREE (Relugolix, estradiol and norethindrone acetate tablets) for the management of moderate to severe pain associated with endometriosis in pre-menopausal women on October 17, 2023. On September 22, 2023, Health Canada also approved MYFEMBREE for the management of heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women. This combination therapy oral treatment is taken once daily and provides a new option for women to manage their symptoms related to endometriosis and uterine fibroids. "Health Canada's approval of MYFEMBREE across the uterine fibroid and endometriosis indications marks a significant milestone in our commitment to women's health," said Lisa Mullett, General Manager, Sumitomo Pharma Canada, Inc. "These are multi-faceted and complex chronic conditions, and we are proud to make new treatment options available to women in Canada." "MYFEMBREE's approval is a testament to the shared commitment between our two companies to support women's health," added Andréa Mueller, Primary Care Portfolio Lead at Pfizer Canada. "We are proud to help women manage their health at all stages of their lives." This approval is based on several comprehensive Phase 3 studies, including the LIBERTY 1 and LIBERTY 2 trials for uterine fibroids and the SPIRIT 1 and SPIRIT 2 trials for endometriosis. "Uterine fibroids and endometriosis are very common conditions affecting millions of Canadians. Endometriosis, in particular, can be a very challenging and complex condition to treat, often resulting in years of delay to diagnosis, said Dr. Sony Sukhbir Singh, Professor and Chair of the Department of Obstetrics and Gynecology, at the University of Ottawa. "These conditions can cause debilitating symptoms such as pain and bleeding, impacting daily life and overall well-being for many girls, women and gender diverse individuals." Following this approval Pfizer Canada will lead commercialization efforts of MYFEMBREE in the uterine fibroid and endometriosis indications. In partnership with Sumitomo Pharma in Canada, Pfizer Canada is currently assessing the timeline of availability for MYFEMBREE and are committed to bringing supply of this medicine to Canadians as quickly as possible. About Uterine Fibroids Uterine fibroids are the most common benign tumors in women of reproductive age.1 Uterine fibroids may be underdiagnosed due to several factors. Roughly 50 to 80% of women may have asymptomatic fibroids, meaning they don't experience noticeable symptoms. Additionally, some women with fibroid-related symptoms, such as heavy menstrual bleeding and pain, might not seek medical attention because they consider these issues to be a normal part of their menstrual cycles. Furthermore, healthcare providers may sometimes dismiss these symptoms as normal, contributing to the underestimation of uterine fibroid prevalence in Canadian women. 2,3,4,5 About Endometriosis Endometriosis is a chronic disease characterized by growth of endometrial-like tissue outside the uterus.6 This growth of endometriotic tissue relies on estrogen, a hormone crucial for regulating the female reproductive system.7 Endometriosis mainly affects women of reproductive age, occurring between their first menstrual period and menopause, when estrogen levels decline.8 In Canada, 7.0% of women aged 18-48 have endometriosis, with an average diagnosis age of 27.9. Most Canadian women experience symptoms before diagnosis with an average delay of 5.4 years in diagnosis.9 Symptoms include menstrual pain, pelvic pain, and pain during sex, with 60% reporting moderate to severe pain. 6,9,10 Endometriosis can impact fertility, quality of life, and work productivity.11 About MYFEMBREE® MYFEMBREE® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) has received a dual indication approval, making it the first Health Canada-approved oral treatment to manage uterine fibroids and endometriosis. MYFEMBREE was approved by the U.S. Food and Drug Administration for the treatment of heavy menstrual bleeding associated with uterine fibroids in May 2021 and for the management of moderate to severe pain associated with endometriosis in August 2022. About Sumitomo Pharma Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information, please visit or follow us on LinkedIn. About Pfizer Canada Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies. Our diversified healthcare portfolio includes some of the world's best known and most prescribed medicines and vaccines. We apply science and our global resources to improve the health and well-being of Canadians at every stage of life. Our commitment is reflected in everything we do, from our disease awareness initiatives to our community partnerships. To learn more about Pfizer Canada, visit pfizer.ca or you can follow us on LinkedIn, Facebook, Twitter or YouTube. 1 BMC Public Health, Global, regional, and national time trends in incidence, prevalence, years lived with disability for uterine fibroids, 1990–2019: an age-period-cohort analysis for the global burden of disease 2019 study, , Accessed August 22, 2023 2 Laberge PY, Vilos GA, Vilos AG, Janiszewski PM. Burden of symptomatic uterine fibroids in Canadian women: a cohort study. Curr Med Res Opin. 2016;32(1):165-75. doi:10.1185/03007995.2015.1107534 3 Bukulmez O, Doody KJ. Clinical features of myomas. Obstet Gynecol Clin North Am. Mar 2006;33(1):69-84. doi:10.1016/j.ogc.2005.12.002 4 Stovall DW. Clinical symptomatology of uterine leiomyomas. Clin Obstet Gynecol. Jun 2001;44(2):364-71. doi:10.1097/00003081-200106000-00022 5 Zimmermann A, Bernuit D, Gerlinger C, Schaefers M, Geppert K. Prevalence, symptoms and management of uterine fibroids: an international internet-based survey of 21,746 women. BMC Women's Health. Mar 26 2012;12:6. 6 Zondervan, K.T., et al., Endometriosis. Nat Rev Dis Primers, 2018. 4(1): p. 9. 7 Ahn, S.H., et al., Pathophysiology and immune dysfunction in endometriosis. BioMed research international, 2015. 2015. 8 Stratton, P. and K.J. Berkley, Chronic pelvic pain and endometriosis: translational evidence of the relationship and implications. Hum Reprod Update, 2011. 17(3): p. 327-46. 9 Singh, S., et al., Prevalence, symptomatic burden, and diagnosis of endometriosis in Canada: cross-sectional survey of 30 000 women. Journal of Obstetrics and Gynaecology Canada, 2020. 42(7): p. 829-838. 10 Becker, K., et al., Real world data on symptomology and diagnostic approaches of 27,840 women living with endometriosis. Scientific Reports, 2021. 11(1): p. 1-9. 11 Macer, M.L. and H.S. Taylor, Endometriosis and infertility: a review of the pathogenesis and treatment of endometriosis-associated infertility. Obstetrics and Gynecology Clinics, 2012. 39(4): p. 535-549. SOURCE Sumitomo Pharma America

Company Adds New Chief Medical Officer, Vice President of Project Management & Strategic Initiatives, and Vice President of Technical Operations REDWOOD CITY, Calif., Oct. 18, 2023 /PRNewswire/ -- Antiva Biosciences, a biopharmaceutical company developing novel, topical therapeutics for the treatment of high-risk infections and pre-cancerous lesions caused by human papilloma virus (HPV), today announced several key new appointments designed to strengthen the company's leadership as it continues to advance its lead development candidate, ABI-2280. The company has added Elaine Chien, M.D., FACOG, as chief medical officer, Susan Wilson, Ph.D., as vice president of project management and strategic initiatives, and Rajashree Joshi-Hangal, Ph.D., as vice president of technical operations. Collectively, these individuals bring Antiva significant industry experience in areas directly related to the company's ongoing work in developing innovative treatments for diseases caused by HPV infection. "With the closing of our Series E financing earlier this year, Antiva entered an important new phase as we work to advance ABI-2280 into key efficacy studies across multiple indications. With this as a backdrop, we are thrilled to bring aboard Elaine, Susan, and Rajashree to fortify our growing team, while expanding the range of leaderships' expertise to align with our ambitious clinical development strategy," said Kristine Ball, chief executive officer of Antiva. "These individuals have each established themselves as highly regarded biopharmaceutical executives with impressive resumes of accomplishments and we look forward to them continuing to make an impact by contributing to Antiva's important work in the areas global and women's health." Antiva is currently working to advance ABI-2280 into key efficacy studies. Planned studies include Phase 2a clinical trials for the treatment of high-grade cervical intraepithelial neoplasia (CIN 2,3) and for the treatment for high-risk HPV infection, specifically in subtypes that can lead to cancer. ABI-2280 has potent antiviral activity across all genotypes of HPV and works by both directly blocking HPV replication and inducing apoptosis in HPV-infected lesions, while sparing normal cells. Antiva has leveraged its development expertise to formulate a vaginal tablet of ABI-2280 that will enable self-administration at diagnosis and facilitate worldwide distribution, increasing impact potential for patients. Dr. Chien is a board-certified, licensed OB/GYN physician with more than 25 years of clinical and biopharmaceutical industry experience, including leading multidisciplinary teams in support of the advancement of early to late-stage clinical programs. In her role as Antiva's CMO, Dr. Chien will be responsible for the creating and overseeing strategy, direction, and execution of the company's clinical development plans. Prior to joining Antiva, she served as vice president, clinical development and medical safety at Mirum Pharmaceuticals, where she was responsible for overall strategic and executional oversight of all development programs for the company's clinical-stage asset, as well as global medical safety and pharmacovigilance for all of Mirum's commercial and clinical assets. Prior to Mirum, Dr. Chien was the clinical development lead for the Myfembree® global Phase 3 endometriosis program at Myovant Sciences, and the medical safety lead at Clovis Oncology for the U.S. and EU approvals of Rubraca® for BRCA-positive ovarian cancer. Dr. Wilson is a seasoned biopharmaceutical industry executive with more than 25 years of experience leading and managing complex global research and development programs. As vice president of project management and strategic initiatives, she will be charged with establishing and leading Antiva's program management function, aligning and mobilizing cross-functional teams to drive execution of the company's development programs. Most recently, Dr. Wilson served as vice president, program, portfolio and alliance management (PPAM) at Revolution Medicines. During this time, she provided PPAM leadership for the company's portfolio of oncology-focused research and development assets from startup through rapid expansion of its clinical-stage portfolio. Dr. Wilson also provided key contributions to KAI Pharmaceuticals leading up to its July 2012 acquisition by Amgen, serving as the company's vice president, project management and project leader for KAI-4169, its lead development asset. Dr. Joshi-Hangal possesses more than 25 years of product development experience in the biopharmaceutical industry combining technical, operational, and regulatory aspects of chemistry, manufacturing, and controls (CMC). In her new role as vice president of technical operations with Antiva, she will be responsible for providing strategic direction, technical leadership, and operational execution of CMC development and manufacturing activities in support of the company's clinical development programs. Previously, Dr. Joshi-Hangal led CMC, regulatory affairs at Myovant Sciences, where she developed, implemented, and advised on global CMC regulatory strategies for new and late-stage programs including Myfembree® and Orgovyx®. She has also held positions of increasing managerial responsibilities in both technical and regulatory CMC areas at Astex Pharmaceuticals. During that time, Dr. Joshi-Hangal aided in the approval of hypomethylating agents, Dacogen® followed by Inqovi® by strategizing creative dose escalation formulations and shortening early phase of clinical development. About HPV-Related Diseases and Cervical Cancer Human Papilloma Virus (HPV) is so common that nearly all sexually active men and women are infected with the virus at some point in their lives. Many of these are transient infections the body is capable of clearing, but this typically takes months to years. When the infections persist, they are known to drive the formation of malignancies, including cervical, anal, vulvar, penile, and head and neck cancers. The introduction of prophylactic vaccines for HPV was a major step forward in the fight against HPV-associated cancers by preventing infection by certain high-risk HPV subtypes. However, due to low adoption rates in the US, EU, and Japan, and limited access to the vaccines in developing countries, HPV infections and the disease states driven by such infections remain a major unmet clinical need. Globally, cervical cancer is the fourth most common cancer in women and as such represents a major public health problem. According to the World Health Organization, an estimated 604,000 women were diagnosed with cervical cancer worldwide and approximately 342,000 women died from the disease in 2020. About Antiva Biosciences Antiva Biosciences, Inc. is a clinical-stage biopharmaceutical company developing novel, topical therapeutics for the treatment of diseases caused by HPV infection. The company, based in the San Francisco Bay Area, was founded in 2012 by Dr. Karl Hostetler of The University of California San Diego. The company's lead drug candidate, ABI-2280 is being developed as a topical treatment for high-grade cervical intraepithelial neoplasia (HSIL, CIN 2,3) and for women with high-risk HPV infection. For more information, please visit: . Contact Information: Kristine Ball Antiva Biosciences, Inc. 650-822-1400 [email protected] Tim Brons Vida Strategic Partners (media) 646-319-8981 [email protected] SOURCE Antiva Biosciences, Inc.