Hamlet Pharma has extended and expanded the agreement with the Polypeptide Group, to produce larger quantities of the synthetic peptide Alpha1. The new production, at a larger scale, will be essential for future expansions of the clinical trial program in bladder cancer. The drug candidate Alpha1H is produced in two steps.

The Alpha1 peptide is synthesized separately and then mixed with other constituents to form Alpha1H for clinical trials. Large scale synthesis methods have been developed together with Polypeptide Group in Strasbourg and Malmo, at GMP (Good Manufacturing Practice) quality, and the product has shown excellent stability. The production of synthetic Alpha1H is now expanded to ensure larger quantities of the peptide and guarantee continued access to the peptide for clinical studies.

This requires a technical development step to scale up the current production protocol, as well as the production of kilogram quantities of the peptide, at the Polypeptide production site in Malmo, Sweden.