The depot formulation using Debiopharm's Debio PLGA (polylactic glycolic acid copolymer) is suitable for the formulation of low molecular weight drugs and peptides. The process allows the encapsulation of the bioactive drug candidate in the polymeric matrix. Once injected, the formulation enables a controlled release of the drug, the release rate being dependent upon the hydration and the degradation rate of the PLGA polymer.
The three month formulation was approved in Germany on 18 March, and joins a one month version of Pamorelin that is already registered in Germany. It will be marketed by France's Ipsen, with Debiopharm receiving royalties on sales.
Triptorelin pamoate is a luteinising hormone releasing hormone (LHRH) antagonist, a class that achieves sales of around €200 million a year in Germany and is growing at an annual rate of 14 per cent. An estimated 800,000 patients are currently being treated for prostate cancer in Germany.
Rolland-Yves Mauvernay, chief executive of Debiopharm, said: "Our validated platform allows for a more efficient delivery of the drug," adding that the company is seeking partners to apply the technology to other pharmaceutical products.
Other products in Debiopharm's pipeline that are formulated using the Debio PLGA technology include Sanvar SR (vapreotide) for oesophageal variceal bleeding in three month (Phase III) and one month (preclinical) formulations; four and six month depots of triptorelin pamoate; and a one month depot of ZT-1 for Alzheimer's disease (preclinical).