Lausanne, Switzerland, March 23, 2004 – Debiopharm S.A., the independent drug-development company specialising in oncology, endocrinology, CNS and niche diseases, today announces that Pamorelin long acting (LA) 11.25mg, a three month formulation, was granted final marketing authorization in Germany on March 18, 2004 by the Bundesinstitut für Arzneimittel und Medizinprodukte, also known as BfArM. Pamorelin LA, for the treatment of prostate cancer, 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.
Debiopharm conducted the formulation, scale-up, optimization, GMP, clinical trials and registration work for the development of Pamorelin LA. Debio R.P. will supply its partner Ipsen S.A. 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 R.P., a world leader in PLGA technology developed a one and three-month formulation of triptorelin pamoate, currently marketed as Decapeptyl® in Europe by Ipsen and Trelstar® in the US, for the treatment of prostate cancer. This preparation was the first sustained-release formulation of an LHRH agonist allowing the continuous release of a drug. The market for LHRH therapy in Germany is estimated to be 200 million € with an annual growth of 14%. An estimated 800’000 patients are currently being treated for prostate cancer.
“This authorisation shows the success of our proprietary Debio® PLGA technology. We have four products approved by the European and US Authorities,” said Rolland-Yves Mauvernay, President and CEO of Debiopharm. “Our validated platform allows for a more efficient delivery of the drug. Currently we add value to our portfolio of products by using our proprietary Debio® PLGA technology and we collaborate with third parties on either New Molecular Entities or for the life-cycle management of their important products.”
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.
About Debio® PLGA
Debio® PLGA is suitable for the formulation of low molecular weight drugs and peptides. It is a sustained-release formulation, based on polylactic glycolic acid copolymers (PLGA). 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. Debiopharm has developed great expertise with the Debio® PLGA technology and uses processes such as the dry process, by which the peptide and the polymer are mixed together without the use of a solvent.
Debiopharm, founded in 1979 in Lausanne, Switzerland, focuses on evaluating compounds with promising in-vivo results in animals, to in-license, develop for global registration, and out-license to sales and marketing pharmaceutical partners. Debiopharm’s major commercial successes to date are Eloxatin®, one of Sanofi-Synthelabo’s leading marketed products, Decapeptyl®, the leading product of Ipsen in Southern Europe, and Trelstar®, with combined sales estimated to be in excess of $1.8bn in 2004.
Debiopharm is one of an established group of three complementary companies, Debiopharm, Debio R.P. and Debioclinic, with a successful track record in developing, registering and out-licensing innovative therapeutics. Debio R.P. is a leader in polymer-based controlled release technologies that allow certain drugs like proteins, peptides and anti-cancers to be delivered in customised, sustained-release formulation. From its FDA-inspected manufacturing facility in Martigny, Switzerland, Debio R.P. also conducts feasibility studies, formulation selection, optimisation, scale-up and cGMP manufacturing from clinical trial supplies to commercial scale. Debioclinic is a contract research organisation, specialised in oncology and dedicated to clinical development, providing regulatory, biometric and clinical support in line with cGCP.