Solvay Pharmaceuticals completes market authorization in 28 European countries for Duodopa® – its treatment for advanced Parkinson’s disease.
Solvay Pharmaceuticals has obtained market authorization for DUODOPA®, the product for treating advanced Parkinson’s disease in 28 European countries. DUODOPA® now has a registration in Sweden, Austria, Germany, Denmark, Spain, Finland, France, The Netherlands, Norway, Portugal, Belgium, Greece, Ireland, Italy, United Kingdom, Cyprus, Czech Republic, Estonia, Hungary, Iceland, Liechtenstein, Lithuania, Luxembourg, Latvia, Malta, Poland, Slovenia, and Slovakia; The product was already on the market in 15 countries, but has now gained access to 13 other European countries via a Mutual Recognition Procedure. This means that Solvay Pharmaceuticals can now market the product throughout Europe.
This procedure went faster than usually as both EMEA (the European Agency for the Evaluation of Medicinal Products) and the European Committee have supported the regulatory authorities in the various countries in view of DUODOPA’s orphan drug status. This orphan drug status means that the product is used for a severe condition for a group of patients for which there is no alternative treatment.
Werner Cautreels, Chief Executive Officer of Solvay Pharmaceuticals, says: “For Solvay this means a European acknowledgement of the significant added therapeutic value of DUODOPA® for those patients that suffer from advanced Parkinson’s disease and that do not have other treatments available”.
Ongoing consultations with FDA is expected to allow the start of clinical work in 2006 to support the submission of a US-NDA, aimed for 2007.
DUODOPA® is a new and unique treatment based on continuous dopaminergic stimulation by means of a formulation of the well-known substances, levodopa and carbidopa, dispersed as a viscous gel. Using a patient-operated portable pump, the drug is continuously delivered via a tube directly into the upper small intestine, where it is rapidly absorbed. This delivery system ensures a more even supply and uptake compared with the conventional combination of tablet treatment.
The use of DUODOPA® results in improved mobility for patients with advanced Parkinson’s disease, which in turn leads to a more normal life with better opportunities for social interaction and increased quality of life. DUODOPA® is indicated for the treatment of severe Parkinson’s symptoms and can be used as a monotherapy offering the patient a documented more effective and predictive treatment.
SOLVAY PHARMACEUTICALS is the pharmaceuticals entity of Solvay. It is a research driven pharmaceutical company that seeks to fulfil carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardio-metabolic, influenza vaccines, pancreatic enzymes, gastroenterology and men’s and women’s health. Solvay Pharmaceuticals employs about 13,000 people worldwide after the acquisition of Fournier Pharma in July 2005.
SOLVAY is an international chemicals and pharmaceuticals group with headquarters in Brussels. It is present in more than 50 countries and employs some 33,000 people in its Chemicals, Plastics and Pharmaceuticals activities. Including Fournier Pharma, its 2004 sales amounted to EUR 8.5 billion. Solvay is listed on the Euronext 100 index of top European companies. Details are available at www.solvay.com.