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 agreement marks a key step following AnGes’ recent completion of clinical trials and its plan to submit a biologics license application (BLA). With Boehringer Ingelheim now formally engaged for the manufacturing of the drug substance, both companies aim to advance regulatory approval and ensure future patient access.

The collaboration will be led through Boehringer Ingelheim BioXcellence, the company’s contract development and manufacturing organisation (CDMO), which has been producing the plasmid DNA active ingredient using proprietary microbial technology in E. coli at its Vienna site for nearly two decades. The agreement now extends this longstanding partnership into the commercial supply phase.

Ei Yamada, president and CEO of AnGes, said the collaboration with Boehringer underscores their commitment to bringing the gene therapy closer to approval. A pre-BLA meeting and Chemistry, Manufacturing, and Controls (CMC) updates will soon be provided to the US FDA. Ute Lehmann, head of key account management and business development at Boehringer Ingelheim BioXcellence, highlighted the company’s focus on high-quality biologics manufacturing to help partners achieve regulatory milestones and launch innovative therapies.

PAD affects around 200 million people worldwide and can lead to severe complications, including ulceration, infection, and limb amputation. Studies show that the five-year mortality rate following a major lower extremity amputation stands at 57 percent, second only to lung cancer. Early treatment is critical, and AnGes believes its hepatocyte growth factor (HGF) gene therapy product could improve outcomes by extending ulcer- and amputation-free days, enhancing quality of life, and reducing healthcare burdens.

Both companies view this agreement as a vital step in accelerating development of the HGF gene therapy and expanding its potential impact on PAD patients worldwide.