Boehringer Ingelheim Partners with AnGes for HGF Gene Therapy

Boehringer Ingelheim has entered into a contract development and manufacturing agreement with AnGes Inc. for the active pharmaceutical ingredient of AnGes’ investigational Hepatocyte Growth Factor (HGF) gene therapy aimed at treating Peripheral Arterial Disease (PAD). This partnership is a continuation of nearly two decades of collaboration between the two companies, leveraging Boehringer Ingelheim’s expertise in microbial manufacturing.

The agreement will see the production of the drug substance take place at Boehringer Ingelheim’s microbial manufacturing site in Vienna, Austria. This facility specializes in producing plasmid DNA using microbial technology, specifically in *Escherichia coli* (E. coli), which is essential for the development of gene therapies.

AnGes recently announced the successful completion of clinical trials for its HGF gene therapy and plans to submit a Biologics License Application (BLA) to the US Food and Drug Administration (FDA). This move is significant as PAD affects more than 200 million people globally, highlighting the urgent need for innovative treatment options.

Collaboration History and Future Goals

The partnership between Boehringer Ingelheim and AnGes began nearly twenty years ago, initially focused on the supply of clinical trial materials. As noted by Ei Yamada, PhD, President & CEO of AnGes, “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.” This collaboration underscores the commitment of both companies to advance medical solutions for PAD.

Boehringer Ingelheim emphasized that this agreement showcases its capabilities in microbial contract development and manufacturing. The company is dedicated to supporting its partners in achieving regulatory milestones such as BLA approval.

AnGes also highlighted the importance of early intervention for PAD patients, noting that timely treatment can significantly reduce complications, including ulceration, infections, and even amputations. The collaboration with Boehringer Ingelheim is expected to accelerate the development of this promising gene therapy, thereby enhancing its corporate value and potential impact on patient care.

As this partnership progresses, the focus remains on advancing the HGF gene therapy through regulatory processes and ultimately making it available to patients in need. This agreement represents a critical step in the ongoing efforts to develop effective treatments for a condition that significantly impacts the quality of life for millions around the world.