QuiaPEG Pharmaceuticals Holding AB (publ) (“QuiaPEG”), which develops versions of clinically validated or already approved drugs, today announced it has signed an agreement with the German company Celares GmbH to develop an optimized process suitable for large scale production of products based on QuiaPEG’s Uni-Qleaver technology, including QPG-1029 according to current Good Manufacturing Practice (cGMP).
The agreement with Celares, which has long experience within pegylation chemistry, is a complement to QuiaPEG’s current collaboration with the Chinese company Xiamen SinoPEG Biotech. Together, QuiaPEG is now ready to optimize the production process of the proprietary pegylation technology Uni-Qleaver, for the development of prodrugs and so called biobetters with improved pharmacological properties, and the leading candidate substance QPG-1029 (pegylated liraglutide) for the treatment of type 2 diabetes and obesity.
QuiaPEG achieved proof-of-concept in a preclinical efficacy study with QPG-1029 in February 2020, demonstrating that the Uni-Qleaver platform worked as intended significantly decreasing the technical risks of the platform and increasing the opportunities to reach future licensing agreements.
“Partnering with Celares is a big step forward for us as we prepare to scale up the production of QPG-1029 for upcoming studies and also to expand our manufacturing capacity of the Uni-Qleaver pegylation platform itself, something that potential licensees demand,” said Marcus Bosson, CEO of QuiaPEG.
“The Uni-Qleaver platform is the most promising and broadest applicable releasable pegylation technology on the market, and we are looking forward to the collaboration with QuiaPEG”, said Dr. Ralf Kraehmer, CEO of Celares.
The global diabetes drug market was estimated at 42 billion USD in 2019, of which the fast- growing GLP1 segment represents 20%. Liraglutide, which is marketed under the Victoza andSaxenda brands, is the market leading GLP1 product with annual sales of approximately 4 billion USD. The base patent expires in 2022.
QuiaPEG Pharmaceuticals Holding AB (publ) is a drug development company based on a patented drug delivery platform, Uni-Qleaver®. The company develops improved and patentable forms of drugs under development or which have already been approved by pharmaceutical authorities. These refined and better forms of pharmaceuticals are based on the company’s unique and patented technology platform. The company is listed on Spotlight (ticker: QUIA). For more information, please visit www.quiapeg.com.
Celares GmbH, Berlin, Germany, a privately-owned company, is a recognized leader in the field of pegylation and chemical modification of biopharmaceuticals. The company provides high-quality customized services including feasibility studies, up-scaling and process development, as well as development and validation of required analytical methods.
Furthermore, Celares offers manufacturing services for pegylated and chemically modified biopharmaceuticals used in vivo and clinical phase I studies. Based on long-term experience and excellent scientific know-how, Celares accelerates customers’ development programs. For more information, please visit www.celares.com.