Boehringer Ingelheim has signed a contract development and manufacturing agreement with AnGes Inc. to produce the drug substance for AnGes’ investigational Hepatocyte Growth Factor (HGF) gene therapy aimed at treating Peripheral Arterial Disease (PAD). This agreement follows AnGes’ recent announcement confirming the completion of clinical trials and plans to file a Biologics License Application (BLA) with the FDA.
Under the deal, Boehringer Ingelheim BioXcellence, the company’s biopharmaceutical contract manufacturing unit, will manufacture and supply the active pharmaceutical ingredient—the plasmid DNA—using proprietary microbial technology at their Vienna, Austria facility. The partnership for clinical trial supply has been ongoing for nearly 20 years, and this new contract marks a significant step toward regulatory approval and future patient access.
Ei Yamada, President & CEO of AnGes, expressed confidence in the collaboration, highlighting Boehringer Ingelheim’s global expertise in drug and biologics manufacturing. The companies plan to submit Chemistry, Manufacturing, and Controls (CMC) data and engage with the FDA in a pre-BLA meeting soon.
Peripheral Arterial Disease affects around 200 million people worldwide and can lead to serious complications such as ulcers, infections, and limb amputations. PAD’s high mortality rate after major amputations rivals that of lung cancer, emphasizing the urgent need for effective treatments. Early intervention with HGF gene therapy may improve patient outcomes by reducing ulcers and amputations, thereby enhancing quality of life.
Ute Lehmann, Head of Key Account Management and Business Development at Boehringer Ingelheim BioXcellence, reaffirmed the company’s commitment to supporting AnGes in reaching key regulatory milestones and bringing this innovative therapy to patients globally.
This collaboration is expected to accelerate the development and commercialization of AnGes’ HGF gene therapy and strengthen the companies’ shared mission to address the significant unmet needs of PAD patients.