Boehringer Ingelheim, AnGes sign manufacturing agreement for HGF gene therapy product
Ingelheim: Boehringer Ingelheim has announced 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 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. 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%). In addition, The Global Vascular Guidelines 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.
