Pharmaceutical Technology

Boehringer and AnGes link on drug substance manufacture for PAD

The agreement follows AnGes' announcement of the completion of clinical studies and plans to submit a BLA.

Boehringer Ingelheim has entered a contract development and manufacturing agreement for the drug substance of AnGes' investigational therapy targeting peripheral arterial disease (PAD).

PAD is a complex medical issue, impacting 200 million individuals globally. The condition can result in severe complications in the lower extremities, such as infection, ulceration and in severe cases, limb amputation.

This agreement follows AnGes' announcement of the completion of clinical studies, as well as plans to submit a biologics licence application (BLA).

AnGes previously indicated that arrangements for a supply agreement were in progress.

Updates on chemistry, manufacturing and controls (CMC) will shortly be submitted to the US Food and Drug Administration alongside a pre-BLA meeting.

AnGes president and CEO Ei Yamada stated: “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 BioXcellence, the biopharmaceutical contract manufacturing division of Boehringer Ingelheim, will oversee the manufacture and supply of the hepatocyte growth factor (HGF) gene therapy’s active pharmaceutical ingredient.

The plasmid DNA molecule has been produced using microbial technology in E coli at Boehringer's facility in Vienna, Austria, since the initiation of their collaboration almost two decades ago.

Boehringer Ingelheim BioXcellence key account management and business development head Ute Lehmann stated: “At Boehringer Ingelheim BioXcellence, we are committed to leveraging our expertise in biologics manufacturing.

“Therefore, we support our partners with high-quality, reliable manufacturing services to help them reach key regulatory milestones, such as FDA BLA approval, and to bring innovative therapies to patients worldwide.”

In July 2025, Re-Vana Therapeutics, a spin-out from Queen’s University, partnered Boehringer Ingelheim to develop ophthalmic therapies under a licensing agreement.