Action Pharma A/S and Bachem (SWX: BANB) today announced their cooperation on AP214, Action Pharma’s lead compound, about to enter Phase 2 clinical trials in post-surgical organ failure. Since 2002, Bachem has supported Action Pharma by producing the peptide active
ingredient of this drug candidate, by analytical method development, analytical method validation as well as by regulatory services. For the upcoming Phase 2 clinical trial, Bachem also supplies finished dosage forms under its Clinalfa® brand.
Prof. Søren Nielsen, CEO and Co-founder of Action Pharma, commented: “For years, Bachem has supported us as a full-service provider on the active ingredient of our lead compound, a very valuable contribution for our start-up company. The service has been highly professional and efficient throughout. Now, that we enter Phase 2, we are particularly pleased that Bachem can also provide us with the necessary finished dosage forms. This helps us not only to save cost but also to speed up time to market.”
Rolf Nyfeler, CEO of Bachem, said: “The collaboration with Action Pharma is a case in point for our unique business model: our comprehensive service offer, ranging from the development and manufacture of peptides and complex organic molecules through regulatory support up to the production of clinical trial samples, makes us a reliable long-term partner for bio-pharmaceutical companies of any size. At the same time it allows us to share in the
success of our partners, as they progress their drug candidates through the development process.”
The cooperation between Action Pharma and Bachem has been particularly close and also included involvement of Bachem in direct discussions with the US Food and Drug Administration (FDA) last year. Action Pharma has completed clinical Phase 1A, 1B and 1C
studies and filed an Investigational New Drug Application with the FDA in November 2007.
With AP405, Action Pharma has a second peptide-based development compound in its pipeline. This project, targeted at atopic dermatitis, is currently in pre-clinical development. Also for AP405, Bachem is the partner for process development, production and related services.