German pharmaceutical company Boehringer Ingelheim has signed a contract development and manufacturing agreement with Japan-based AnGes.
The collaboration aims to produce AnGes’ experimental gene therapy targeting Peripheral Arterial Disease (PAD).
The partnership follows the conclusion of AnGes’ clinical trials of its investigational PAD treatment and plans for Biologics License Application (BLA) submission.
Boehringer Ingelheim BioXcellence, the biopharmaceutical manufacturing unit of the German firm, will serve as a contract development and manufacturing organisation (CDMO) for AnGes
The CDMO will produce and supply the active pharmaceutical ingredient (API) for the hepatocyte growth factor (HGF) gene therapy.
The gene therapy product has been developed using an in-house microbial technology at its Vienna site, said Boehringer Ingelheim.
Boehringer Ingelheim BioXcellence key account management and business development head Ute Lehmann said: “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.
“We deeply value the opportunity to collaborate with AnGes on their journey toward product launch, and we look forward to contributing to the future success of this important partnership.”
PAD is a significant health concern worldwide, leading to serious complications such as ulceration and limb amputation, and is advocated for early treatment initiation.
AnGes aims to enhance patient outcomes by advancing the HGF gene therapy, potentially increasing ulcer- and amputation-free days.
AnGes president and CEO Ei Yamada 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.”
Recently, Boehringer Ingelheim and Re-Vana Therapeutics entered a strategic collaboration to develop long-acting ophthalmic therapies.
