Carbetocin

SAN DIEGO--( BUSINESS WIRE )--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced multiple business updates and progress on the Company's CNS and rare disease drug candidates, which will be discussed today during a presentation by Catherine Owen Adams, Chief Executive Officer, at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA. “ 2025 is shaping up to be an exciting year as we build on the success of our two growing brands, NUPLAZID and DAYBUE, which together are projected to generate more than $1 billion in net sales this year,” said Catherine Owen Adams, Chief Executive Officer. “ In addition to growing our strong commercial franchises, we are laying the foundation for future growth through global expansion and pipeline advancement. Today, we announced our submission of a marketing authorization application for DAYBUE with the European Medicines Agency and anticipate beginning Managed Access Program–related sales in Europe as early as the second quarter. We are also pleased to share updates on our R&D pipeline—both today and at our first R&D Day in mid-2025—as our lead programs near data readouts. By expanding our reach beyond the U.S. and continuing to advance our pipeline, we believe Acadia is poised for sustained top-line growth and increasing positive cash flow.” Key 2025-2026 Milestones: Announced today that the marketing authorization application for DAYBUE ™ has been submitted to the European Medicines Agency (EMA) with expected approval in the first quarter of 2026. Initiation of Managed Access Programs in Europe in the second quarter of 2025, potentially resulting in the Company’s first revenues from outside the U.S. Enrollment of the last patient in the COMPASS PWS Phase 3 study of ACP-101 in Prader-Willi Syndrome anticipated in the fourth quarter of 2025, followed by top-line results announcement in the first half of 2026. Enrollment of the last patient in the RADIANT Phase 2 study of ACP-204 in Alzheimer’s disease psychosis expected in the first quarter of 2026, followed by top-line results announcement in mid-2026. Initiation of a Phase 2 study of ACP-204 for a second indication in Lewy Body Dementia in the third quarter of 2025. The Company will host its first ever R&D Day in mid-2025. Annual net sales for the full-year 2025 expected to exceed $1 billion for the first time in Company history. Today’s presentation will take place at 9:00 a.m. Pacific Time / 12:00 p.m. Eastern Time. A live webcast of the presentation will be accessible on the Company’s website, Acadia.com, under the investors section and an archived recording will be available on the website for approximately one month following the presentation. About Acadia Pharmaceuticals Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis and multiple other programs targeting neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at Acadia.com and follow us on LinkedIn and X . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements other than statements of historical fact and can be identified by terms such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential,” “continue” and similar expressions (including the negative thereof) intended to identify forward-looking statements. Forward-looking statements contained in this press release, include, but are not limited to, statements about: (i) our business strategy, objectives and opportunities, including support for and innovations in our pipeline assets and business development opportunities, and potential for enhanced shareholder value; (ii) plans for, including timing, development and progress of commercialization, and expected regulatory timelines for trofinetide in the EU; (iii) plans for our pipeline, including the timing and conduct of our clinical trials, anticipated enrollment milestones and the timing and results of data from our clinical trials; and (iv) our estimates regarding our future financial performance, profitability and capital requirements, including our full year 2024 financial guidance and potential achievement of our milestone of annualized net sales in 2025. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. Such risks, uncertainties and other factors include, but are not limited to: our dependency on the continued successful commercialization of NUPLAZID ® and DAYBUE and our ability to maintain or increase sales of NUPLAZID or DAYBUE; our plans to commercialize DAYBUE outside the U.S., including in Canada; the costs of our commercialization plans and development programs, and the financial impact or revenues from any commercialization we undertake; our ability to obtain necessary regulatory approvals for our product candidates and, if and when approved, market acceptance of our products; the risks associated with clinical trials and their outcomes, including risks of unsuccessful enrollment and negative or inconsistent results; our dependence on third-party collaborators, clinical research organizations, manufacturers, suppliers and distributors; the impact of competitive products and therapies; our ability to generate or obtain the necessary capital to fund our operations; our ability to grow, equip and train our specialized sales forces; our ability to manage the growth and complexity of our organization; our ability to maintain, protect and enhance our intellectual property; and our ability to continue to stay in compliance with applicable laws and regulations. Given the risks and uncertainties, you should not place undue reliance on these forward-looking statements. For a discussion of these and other risks, uncertainties and other factors that may cause our actual results, performance or achievements to differ, please refer to our quarterly report on Form 10-Q quarter ended September 30, 2024, filed with the SEC on November 7, 2024, available at www.sec.gov . The forward-looking statements contained herein are made as of the date hereof, and we undertake no obligation to update them after this date, except as required by law.

Maternal mortality in the U.S. has been on the rise, with the rate per 100,000 live births more than doubling from the first decade of the 2000s to the second.Health equity remains a major piece of the puzzle. As of 2022, Black women were more than twice as likely to die from a pregnancy-related condition than women of other racial backgrounds. This highlights shortcomings in access to care, but also points to the general lack of research in the field, said A. Metin Glmezoglu, executive director at the nonprofit Concept Foundation, which leads a project called Accelerating Innovation for Mothers.There have been very few new medicines being registered for these pregnancy conditions in the last 30 to 40 years, Glmezoglu said. If you compare this to innovations in other areas like chronic diseases, it's really tiny in terms of the number of solutions we have.The slow pace of innovation can be traced back to two major mid-20th century tragedies related to prescription drugs the nausea medicine thalidomide for pregnant women led to severe birth defects in thousands of children in the 1950s and 1960s and, not long after that, the hormone diethylstilbestrol was found to cause cancer in women who had been exposed to it in utero.These developments chilled drug research involving pregnant women. But in a twist of fate, what was meant to protect women and their children made it harder to find new drugs for them, Glmezoglu said, driving up mortality rates.These tragedies created this enormous fear and risk averseness in this area because those two drugs were not actually researched properly without a rigorous evaluation before, Glmezoglu said. That created this mindset that pregnant women are vulnerable and we have to protect the fetus, even if it means we have to withhold medication a woman might need.The research shortcomings are global, but they have a greater impact among women in low- and middle-income countries, where clinical research is less, Glmezoglu said.Other challenges include the limited time period of pregnancy, which makes drug testing more difficult. All of these combine for a perfect storm where nobody's investing in this field, he added.A gendered problemWhen women take part in clinical research and become pregnant, they are often taken out of that trial, Glmezoglu said, further thinning the data that becomes available.All of these differences tend to push evaluation to male bodies, male cell cultures and so on, which in the short term may be helpful because you can find solutions easier, but it doesn't help because you are not developing solutions for the other 50% of the population, Glmezoglu said.This was made clear during the COVID-19 pandemic, when vaccine trials excluded pregnant women, even though they were at higher risk of mortality and morbidity from the virus. That shifted the responsibility to healthcare providers and patients to decide whether to receive a shot.Gaining traction for a widespread push to study women's health issues more could partly hinge on winning political and public support.Inclusion of women and inclusion of pregnant and lactating women in trials has for many years been a secondary concern, Glmezoglu said. Any political process that does not support inclusivity and equality is likely to have an adverse effect on women's inclusion in research as a general concern.Mercks effortsJacquelyn Caglia, director of learning, communications and U.S. programs, Merck for MothersPermission granted by Merck for MothersOne success story came out of pharmaceutical giant Merck & Co. in 2018, which through its Merck for Mothers initiative studied the use of heat-stable carbetocin, finding it was not inferior to the standard of care oxytocin at preventing excessive bleeding after birth. The heat-stable nature of the new compound makes it easier to use in countries where refrigeration is difficult to come by.Merck for Mothers has been building evidence for maternal mortality trends since 2011 and providing women with education and health solutions in the U.S., India, Kenya and Nigeria. The initiative has reached more than 30 million women in that time, said Jacquelyn Caglia, director of learning, communications and U.S. programs at Merck for Mothers.Caglias vision is to see a healthcare system with a plan in place to treat mothers in the same way it treats newborns.What are our opportunities to think about mom and baby receiving care together? Our system across the U.S. is not quite set up that way, Caglia said. We have a very clear schedule for the types of care and visits and the timing of those visits that newborns need to have but what's our opportunity to think about mom and the care that they should be receiving alongside the newborn at those same points in time?Through programs like the Safer Childbirth Cities which supports community organizations in cities with high maternal mortality rates Merck for Mothers aims to meet mothers where they are, reducing geographic disparities that cause gaps in outcomes.We're still seeing in our national trends across the U.S. and globally, that most of the deaths, most of the complications, are preventable, which points us in the direction of where we need to intervene, Caglia said. There are continued patterns of differences based on race and ethnicity as well as based on geography ... and those disparities demand our attention. '