Pamorelin receives final marketing authorisation in Germany for prostate cancer
For Pamorelin long acting (LA) 11.25mg three month formulation
Debiopharm's Pamorelin long acting (LA) 11.25mg three month formulation for the treatment of prostate cancer has been granted final marketing authorization in Germany by the Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM).
Pamorelin LA is manufactured at Debio R.P., Debiopharm's FDA-inspected production site in Martigny, Switzerland, using its proprietary validated Debio PLGA technology. A one-month formulation of Pamorelin is already registered in Germany. Debio R.P. will supply its partner Ipsen with commercial quantities of Pamorelin LA, to be marketed in Germany. Debiopharm will receive milestones for the registration and royalties on sales of the product.
Debio PLGA is a sustained-release formulation based on polylactic glycolic acid copolymers (PLGA), and 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.
'This authorisation shows the success of our proprietary Debio PLGA technology,' said Rolland-Yves Mauvernay, president and ceo of Debiopharm. 'Our validated platform allows for a more efficient delivery of the drug.'
Other products in Debiopharm's pipeline that are formulated using the Debio PLGA technology include Sanvar SR vapreotide, a three-month formulation, that is currently in development in clinical phase III. ZT-1, Decapeptyl four- and six-month, and Sanvar one-month are in preclinical stage.