This collaboration includes Boehringer Ingelheim's commitment to high-quality biologics manufacturing, supporting regulatory milestones such as FDA approval and the therapy's eventual launch.

Boehringer Ingelheim and AnGes have formalized a development and manufacturing partnership to advance AnGes' HGF gene therapy for peripheral arterial disease (PAD), with Boehringer Ingelheim producing the drug substance using proprietary technology.

Ute Lehmann from Boehringer Ingelheim highlighted their dedication to high-quality biologics manufacturing to support regulatory milestones and the successful launch of innovative therapies.

PAD affects around 200 million people worldwide and can lead to severe complications like ulcers, infections, and limb amputations, with a 57% five-year mortality rate after major lower extremity amputation.

AnGes' CEO, Ei Yamada, expressed confidence in the collaboration with Boehringer Ingelheim and their shared goal of achieving FDA approval, emphasizing the importance of Boehringer's manufacturing expertise.

Early treatment of PAD is crucial, as initiating therapy promptly can improve patient outcomes and reduce the risk of severe complications, including amputations.

Following successful clinical trials, AnGes announced plans to submit a Biologics License Application (BLA) to the FDA by August 8, 2025, marking a significant step toward regulatory approval.

Recent partnerships by Boehringer Ingelheim aim to develop therapies for various conditions, including retinal diseases, psoriasis, metabolic diseases, and cancer, with potential milestone payments and royalties totaling hundreds of millions of dollars.

Boehringer Ingelheim's BioXcellence division has been producing the active plasmid DNA for nearly 20 years using proprietary microbial technology at its Vienna site, supporting the manufacturing of the gene therapy.

This partnership is part of Boehringer Ingelheim's broader expansion strategy in 2025, which includes collaborations with several biotech and pharmaceutical companies.

The Global Vascular Guidelines recommend early intervention in PAD to improve outcomes, and HGF gene therapy could increase ulcer- and amputation-free days, enhancing quality of life and preventing severe complications.