Boehringer Ingelheim has signed a contract development and manufacturing agreement with AnGes Inc. for the drug substance of AnGes’ investigational therapy for Peripheral Arterial Disease (PAD). This milestone follows AnGes’ August 8, 2025 announcement confirming the completion of clinical trials and its plan to proceed with a Biologics License Application (BLA).
With the supply agreement now finalized, both companies will continue their collaboration toward regulatory approval and future patient access.
The therapy’s active pharmaceutical ingredient (HGF gene therapy plasmid DNA) will be produced by Boehringer Ingelheim BioXcellence™, the company’s contract manufacturing division. Using proprietary microbial technology in E. coli, the product has been manufactured at Boehringer’s Vienna site for nearly two decades as part of earlier clinical trial supply.
Ei Yamada, PhD, President & CEO of AnGes, expressed confidence in the partnership:
“We proudly collaborate with Boehringer Ingelheim BioXcellence™, one of the world’s top biologics manufacturers, and look forward to our joint efforts toward FDA approval.”
Boehringer executives also emphasized their commitment to delivering high-quality, reliable biologics manufacturing to support partners through critical regulatory milestones such as FDA BLA approval.
Peripheral Arterial Disease (PAD) affects more than 200 million people worldwide, leading to serious complications such as ulceration, infection, and limb amputation. Research shows that the five-year mortality rate following a major amputation (57%) is second only to lung cancer (80%). Early intervention is recommended by the Global Vascular Guidelines, underscoring the potential value of introducing HGF gene therapy at earlier stages of PAD.
AnGes believes that its collaboration with Boehringer will accelerate the development and approval pathway, while also contributing to its medium-term corporate value and ultimately improving patient outcomes by reducing amputations and enhancing quality of life.