- Boehringer Ingelheim has signed a contract development and manufacturing agreement with AnGes for the drug substance of its HGF gene therapy for Peripheral Arterial Disease (PAD).
- The collaboration builds on nearly 20 years of work, with production continuing at Boehringer’s microbial manufacturing site in Vienna, Austria.
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. The therapy is being developed for the treatment of Peripheral Arterial Disease (PAD), which affects more than 200 million people worldwide.
The new agreement follows AnGes’ announcement earlier this month confirming the completion of clinical trials and its plan to file a Biologics License Application (BLA) with the US Food and Drug Administration. Boehringer Ingelheim BioXcellence™, the company’s biopharmaceutical contract manufacturing arm, will continue to manufacture the plasmid DNA molecule using microbial technology in E. coli at its Vienna facility. The collaboration between the two companies began almost two decades ago with clinical trial supply.
Ei Yamada, PhD, President & CEO of AnGes, said: “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.”
Boehringer Ingelheim stated that the partnership highlights its expertise in microbial contract development and manufacturing and its commitment to supporting partners in reaching regulatory milestones, such as BLA approval.
AnGes noted that early initiation of treatment for PAD patients may reduce complications such as ulceration, infection, and amputation, and believes that the collaboration will accelerate the development of the gene therapy and enhance its corporate value.
