Boehringer Ingelheim is pleased to announce the signing of a contract development and manufacturing agreement with AnGes Inc. for the drug substance of AnGes' investigational treatment for Peripheral Arterial Disease (PAD). This milestone follows AnGes' recent announcement on August 8, 2025 confirming the completion of clinical trials and its intention to proceed with a Biologics License Application (BLA). At that time, AnGes also indicated that final arrangements for a supply agreement were underway. With the agreement for contract development and manufacturing of the product’s drug substance by Boehringer Ingelheim now in place, both companies will continue their collaboration toward regulatory approval and future patient access.
Boehringer Ingelheim BioXcellence™, the biopharmaceutical contract manufacturing branch of the corporation, serves as a contract development and manufacturing organization (CDMO) for AnGes, responsible for manufacturing and supplying the active pharmaceutical ingredient of the Hepatocyte Growth Factor (HGF) gene therapy product. The plasmid DNA molecule has been manufactured using proprietary microbial technology in E. coli at Boehringer's site in Vienna, Austria, since the collaboration for clinical trial supply began nearly 20 years ago.
Ei Yamada, PhD, President & CEO, AnGes, says: “We proudly collaborate with Boehringer Ingelheim BioXcellence™, one of the top manufacturers of drugs and biologics in the world, and look forward to our mutual efforts toward a successful FDA approval.” Further updates regarding the Chemistry, Manufacturing, and Controls (CMC) will be provided to the FDA along with a pre-BLA meeting in the near future.
“At Boehringer Ingelheim BioXcellence™, we are committed to leveraging our expertise in biologics manufacturing. Therefore, we support our partners with high-quality, reliable manufacturing services to help them reach key regulatory milestones, such as FDA BLA approval, and to bring innovative therapies to patients worldwide. We deeply value the opportunity to collaborate with AnGes on their journey toward product launch, and we look forward to contributing to the future success of this important partnership,” says Ute Lehmann, Head of Key Account Management and Business Development at Boehringer Ingelheim BioXcellence™.
PAD is a complex medical condition that affects 200 million people worldwide and can lead to extremely devastating complications in the lower extremity, including ulceration, infection, and ultimately limb amputation.*1 When compared to cancer, as reported by Armstrong et. al. the 5-year mortality rate following a major (proximal to ankle) lower extremity amputation (57%) is second only to lung cancer (80%).*2,3 In addition, The Global Vascular Guidelines*4 recommend initiation of treatment in the early stages of PAD. Therefore, starting treatment with HGF gene therapy product for patients with PAD in a relatively early stage may contribute to increased ulcer- and amputation-free days, thereby improving the patient's quality of life and therefore prevent infections and amputations. AnGes believes that the continued collaboration with Boehringer Ingelheim BioXcellence™ will accelerate the development of HGF gene therapy product and contribute to the enhancement of its medium-term corporate value.
References
*1. Allison MA, et al. Health Disparities in Peripheral Artery Disease: A Scientific Statement from the American Heart Association. Circulation. 2023 Jul 18;148(3):286-296.
*2. Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375.
*3. Armstrong DG, et al. Five year mortality and direct costs of care for people with diabetic foot complications are comparable to cancer. Journal of foot and ankle research. 2020;13(1):1-4.
*4. Michael S. Conte, et al. Global vascular guidelines on the management of chronic limb-threatening ischemia. Journal of Vascular Surgery. 2019; Volume 69, Number 6S.
Boehringer Ingelheim
Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at boehringer-ingelheim.com.
Boehringer Ingelheim BioXcellence™
Building on this, Boehringer Ingelheim BioXcellence™ collaborates with partners to reliably supply biopharmaceutical therapies. The companies’ extensive experience in their contract development and manufacturing has resulted in supplying more than 45 commercial products to patients in need worldwide. It operates a global manufacturing network in key technologies such as mammalian and microbial, turning biologic innovations into commercial successes.
Learn more at www.bioxcellence.com.
About AnGes, Inc.
AnGes is a biopharmaceutical company committed to developing innovative medicines as a global leader in gene medicine. The gene medicines we develop are a new type of biopharmaceuticals that utilize the function of genes, commonly known as nucleic acid drugs or gene medicines. We actively collaborate with academia, pharmaceutical companies and emerging biotech companies both in Japan and internationally to develop new gene medicines. New drugs and treatments are continuously being developed around the world, and genome editing is currently at the forefront of development. Our subsidiary, EmendoBio, is developing high-precision genome editing technology using proprietary nucleases. Furthermore, to meet the expectations of patients who are desperately waiting for treatment due to drug loss and drug lag, we are working to introduce rare disease treatments sold overseas into Japan. In addition to the development and introduction of these medicines, we also operate diagnostic services to enable the early detection and treatment of rare genetic diseases. For more information, visit https://www.anges.co.jp/en/
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Media Contacts
Rebekka Wuester
Communication Lead BioXcellence
Email: bioxcellence(at)boehringer-ingelheim.com
Phone Number: +49 (6132) 77-0