Desmopressin Acetate

SCHAUMBURG, Ill.--( BUSINESS WIRE )--Avenacy, a specialty pharmaceutical company focused on supplying critical medications, looks forward to celebrating its first year of growth and success since launching in October 2023. Backed by a robust global network of development and FDA-inspected contract manufacturing partners, Avenacy has already brought 13 injectable products to the U.S. market to address key gaps in the drug supply chain. “We are incredibly proud of the achievements and progress we have made at Avenacy since launching nearly a year ago as a trusted partner and provider of critical injectable medicines for the U.S. healthcare system,” said Jeff Yordon, Co-Founder and CEO of Avenacy. “We have acted swiftly and decisively to bring over a dozen medications to the U.S. market to help meet the needs of patients, strengthened our financial position with the addition of esteemed pharmaceutical investor and businessman, Dr. Patrick Soon-Shiong, and built out our infrastructure and leadership to support scaling up our business. As we look to usher in the next phase of growth for Avenacy, we will remain steadfast in our goal of enhancing patient care and enabling access to safe, high-quality essential medications.” Through a rigorous and optimized selection process, Avenacy has launched thirteen products in the U.S. market, including: Melphalan Hydrochloride for Injection Bivalirudin for Injection Fosaprepitant for Injection Fulvestrant Injection Furosemide for Injection Desmopressin Acetate for Injection Eptifibatide for Injection Magnesium Sulfate in Water for Injection Isoproterenol Hydrochloride Injection, USP Tranexamic Acid Injection, USP Prochlorperazine Edisylate Injection, USP Palonosetron Hydrochloride Injection, USP Metoclopramide Injection, USP The Company is well-positioned to continue expanding its differentiated portfolio to meet the needs of today’s dynamic drug supply chain while ensuring quality of care to patients. All of Avenacy’s products feature unique packaging and labeling designed to assist healthcare providers with accurate medication selection, thereby supporting a reduction in administration errors and improper dosing. The Company also utilizes ready-to-use formulations of essential medications to help address dosing inaccuracies, enhance patient safety, and streamline efficiency – all with the ultimate goal of improving patient care. Avenacy will be sharing its first year progress, differentiated business model, and diverse partner network at this year’s CPHI 2024 Conference, taking place in Milan from October 8-10. During this time, the Company will be hosting meetings with potential partners, customers, and investors, as it seeks to expand its global presence and portfolio of critical injectable medicines. About Avenacy Avenacy is a U.S.-based specialty pharmaceutical company focused on supplying critical injectable medications used to treat patients in various medically supervised settings, from acute care hospitals to outpatient clinics and physician offices. Through a rigorous and optimized selection process, the Company is building out a pipeline of high-quality FDA approved injectable products in order to ensure a resilient portfolio that can meet the needs of today’s dynamic drug supply chain. With an experienced team, commitment to quality and reliability, and product offerings intended to facilitate safe and efficient patient care, Avenacy strives to be a trusted partner for essential medications. Avenacy was launched in 2023 and is headquartered in Schaumburg, IL. For more information, please visit http://www.avenacy.com/ .

Biden-Harris Administration funds first Defense Production Act Title III award to onshore manufacturing of ingredients for essential medicines ST. LOUIS--(BUSINESS WIRE)--The API Innovation Center (APIIC) today announced that it has been awarded funding by the Administration for Strategic Preparedness and Response’s (ASPR) Center for Industrial Base Management and Supply Chain (IBMSC) to lead the development and domestic production of three critical active pharmaceutical ingredients (APIs) used in the treatment of asthma, diabetes, and anxiety disorders. APIIC will leverage advanced manufacturing technologies and cutting-edge research to further national strength in pharmaceutical innovation and supply chain resilience. The BioMaP-Consortium is a multi-purpose acquisition vehicle comprised of industry partners across the drug and vaccine manufacturing supply chain supported by ASPR’s Biomedical Advanced Research and Development Authority (BARDA). IBMSC will provide $14 million in funding and APIIC will invest an additional $2.4 million into the development of these critical APIs. This funding marks a significant step forward in securing the U.S. pharmaceutical supply chain and addressing national health security risks. At least 83% of the nation’s top 100 generic medicines have no U.S.-based source for the small-molecule APIs found in today’s medication. This dependency on foreign manufacturers has left the U.S. pharmaceutical supply chain vulnerable to shortages and geopolitical conflicts while domestic facilities operate below capacity. The decrease in U.S.-based production for APIs and key starting materials (KSMs) used to make them is widely recognized as a major driver behind this significant national health security risk. While much work remains to improve the return on investment for developing medicines domestically, funding through the BioMaP-Consortium represents a key investment in the ongoing efforts to reshore critical medicines and address ever-increasing drug shortages. Initiative to Address Availability of Essential Medications This initiative will see APIIC lead the development and production of three critical APIs, each chosen for their vital role in U.S. health care, shortage history, as well as inclusion on essential medicines lists: Albuterol: Used to treat asthma and other respiratory conditions. Desmopressin Acetate: Used to treat diabetes insipidus & blood coagulation conditions. Lorazepam: Used to treat anxiety. “This funding represents both a financial commitment and a significant step towards securing America’s pharmaceutical resiliency and patient access to critical medicines. By focusing on developing these high-impact molecules, we are creating a private-public blueprint for driving self-reliance that is essential for national health security and can be replicated across the country,” said Tony Sardella, chair and founder of APIIC. Partnership and Impact This project harnesses the strengths of APIIC’s extensive partner network, including collaborations with leading universities, pharmaceutical manufacturers, and suppliers of KSMs. APIIC will unite the resources and advanced manufacturing technologies of Mallinckrodt Specialty Generics, Apertus Pharmaceuticals, MilliporeSigma, and the University of Missouri–St. Louis (UMSL) to enhance the quality, efficiency, and global competitiveness of U.S.-based pharmaceutical manufacturing. These strategic collaborations form a dynamic product team, capitalizing on each member’s specific expertise, with APIIC providing funding and support to harness their strengths and advanced manufacturing capabilities. “Mallinckrodt Specialty Generics is proud to partner with the API Innovation Center on this critical initiative to bolster the U.S. pharmaceutical supply chain. Our proven expertise in the development, manufacture, and commercialization of active pharmaceutical ingredients in the U.S. positions us extremely well to contribute to this effort. By collaborating with APIIC and its partners, we are both addressing the nation’s drug shortage challenges and strengthening the nation’s ability to manufacture essential medicines domestically,” said Stephen Welch, executive vice president & head of Mallinckrodt Specialty Generics. APIIC will collaborate closely with Apertus Pharmaceuticals on research and development work, leveraging advanced manufacturing technology to produce these critical molecules. “Collaborating with the API Innovation Center has enabled us to scale our cutting-edge research and play a key role in this national initiative to strengthen our pharmaceutical supply chain,” said David Gindelberger, chief executive officer of Apertus Pharmaceuticals. MilliporeSigma, a small and large molecule contract development and manufacturing organization (CDMO) with facilities in St. Louis, will also play a pivotal role. “We are excited to bring our 25 years of CDMO expertise in organic synthesis and bioconjugation of ADCs, producing Active Pharmaceutical Ingredients (API), excipients and critical raw materials, to this partnership. This initiative will not only mitigate risks associated with supply disruptions but can also enhance the U.S. bioeconomy,” said Mark Cooley, site director of one of the St. Louis MilliporeSigma facilities involved in the consortium. “Partnering with the API Innovation Center on this important initiative allows us to leverage our strengths in research, workforce development, and community engagement to support a more secure and self-reliant pharmaceutical supply chain. UMSL is proud to play a key role in advancing these critical efforts, which will have lasting impacts on both our region’s economy and the nation’s health security,” said Dr. Chris Spilling, vice chancellor for research and economic and community development at the University of Missouri-St. Louis. A Roadmap for a Resilient Supply Chain in Missouri APIIC, together with the State of Missouri and the Missouri Technology Corporation, has been developing a state-supported model in the St. Louis region and a strategic framework for creating a resilient national pharmaceutical manufacturing ecosystem. This model is designed to be a replicable blueprint that compliments Missouri’s strengths in infrastructure and workforce development to restore U.S. leadership in pharmaceutical production. To date, the State of Missouri has committed approximately $18 million to API reshoring efforts, demonstrating to other states how to support the “Missouri Model” and take the lead in addressing national supply chain challenges. “Missouri is leading in restoring America’s pharmaceutical manufacturing strength. By focusing on developing active pharmaceutical ingredients right here in Missouri, we are tackling a pressing national health security issue—our over-reliance on foreign suppliers,” said Gov. Mike Parson. “Recognizing our strengths, particularly in pharmaceutical manufacturing, we collaborated with the General Assembly to invest in bringing critical medicine production back to the U.S. The state’s investment, now bolstered by federal support, is a clear indicator that what we are doing in Missouri is working. We are not just talking about solutions. We’re delivering results that are necessary steps toward safeguarding the health and security of our nation.” As it looks to the future, APIIC is committed to driving the U.S. towards pharmaceutical self-reliance, ensuring every hospital, pharmacy, and patient has access to domestically produced critical medication to support national health security. This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Office of Industrial Base Management and Supply Chain (IBMSC), under OT number #75A50123D00003. About the API Innovation Center: The API Innovation Center (APIIC) is a 501(c)(3) nonprofit public benefit organization headquartered in St. Louis, Missouri, dedicated to driving health security and economic growth for the nation and its citizens through U.S.-based production of critical medicines. By investing in and collaborating along the supply chain, APIIC’s model contracts with leading U.S.-based specialists within their pharmaceutical ecosystem to develop and manufacture high-quality domestically produced Active Pharmaceutical Ingredients. APIIC is also committed to expanding access to critical medications through strategic partnerships to commercialize market-competitive supplies of finished drug products and build resiliency in the supply chain. Their mission is to ensure every hospital, pharmacy, and patient has access to domestically produced critical medication to fortify national health security. APIIC is supported by the state of Missouri through the Advanced Manufacturing Resiliency Grant awarded by the Missouri Technology Corporation. To learn more, visit: apicenter.org . About Apertus Pharmaceuticals: Apertus Pharmaceuticals is a contract development and manufacturing organization (CDMO) that develops and manufactures device, OTC and prescription pharmaceutical products. Services include product de-formulation, formulation development, process development, and manufacturing (clinical batch to intermediate scale), including product serialization. Apertus performs an extensive range of analytical method development and validation as well as provides stability programs for all of the medications it produces. Apertus currently manufactures solid oral dose, suppository, liquid and cream products. Apertus is cGMP compliant and maintains Drug Enforcement Administration research and analytical registrations for Schedules II-V. To learn more about Apertus Pharmaceuticals, visit: apertuspharma.com . About Mallinckrodt Specialty Generics: Mallinckrodt’s Specialty Generics business segment is a 150+ year-old business that manufactures approximately 50 FDA-approved active pharmaceutical ingredients and approximately 100 FDA-approved finished dose pharmaceutical products across our network of U.S.-based manufacturing sites. To learn more about Mallinckrodt Specialty Generics, visit . About the Life Science business of Merck KGaA, Darmstadt, Germany The Life Science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has more than 27,000 employees and more than 55 total manufacturing and testing sites worldwide, with a portfolio of more than 300,000 products focused on scientific discovery, biomanufacturing and testing services. Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and electronics. Follow MilliporeSigma on Twitter @MilliporeSigma, on Facebook @MilliporeSigma and on LinkedIn . About the University of Missouri–St. Louis: A Tier 1 national university and Carnegie R2 classification—Doctoral University with High Research Activity— public research university, UMSL, and its four-campus University of Missouri System, provides strong research programs in chemical organic synthesis and advanced pharmaceutical manufacturing methods, such as continuous flow technologies, along with strong industry partnerships. To learn more about the University of Missouri–St. Louis, visit: umsl.edu . Contacts Kaylee Schreiner kaylee.schreiner@fleishman.com