November 29, 2005 Bifeprunox: update on registration submission plan following clinical phase III results
Solvay Pharmaceuticals announces today that Solvay and its European partner H Lundbeck A/S will initiate additional phase III comparative clinical work in order to satisfy European Union requirements.
November 29, 2005 CILANSETRON; suspended registration activites in the U.S., while discussions in Europe continue
Solvay Pharmaceuticals announced today it has suspended regulatory activities for cilansetron with the United States regulatory agency, the Food and Drug Administration.
November 28, 2005 Solvay Pharmaceuticals completes market authorization in 28 European countries for Duodopa®
Solvay Pharmaceuticals has obtained market authorization for DUODOPA®, the product for treating advanced Parkinson’s disease in 28 European countries.
November 14, 2005 Solvay welcomes outcome of Fenofibrate intervention and event lowering in diabetes (field) study
Important news for Solvay Pharmaceuticals’ fenofibrate franchise
October 12, 2005 Solvay’s Fluvoxamine maleate is first drug approved for the treatment of social anxiety disorder in Japan
SOLVAY PHARMACEUTICALS announces today that Meiji Seika Kaisha Ltd. (Tokyo) and Solvay Seiyaku K. K. (Tokyo) obtained approval of additional indication of Social Anxiety Disorder…
September 26, 2005 Solvay and Pronova Biocare sign license agreement for Omacor®
SOLVAY PHARMACEUTICALS and PRONOVA BIOCARE (Norway) announce today the signing of an additional license and supply agreement for OMACOR®, a product indicated for the secondary prevention after myocardial infarction (MI) and hypertriglyceridemia.
September 06, 2005 Solvay Pharmaceuticals launches DUODOPA® in 12 new European countries
Solvay Pharmaceuticals launches DUODOPA® – its treatment for advanced Parkinson’s disease – in 12 new European countries.
August 02, 2005 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.
August 02, 2005 Solvay and Berna Biotech sign a license agreement for Aerugen®
Solvay Pharmaceuticals and Berna Biotech Ltd announce today that they have signed a commercialization and license agreement for Aerugen®, a vaccine for the prevention of Pseudomonas aeruginosa (PA) infection in Cystic Fibrosis (CF) patients.
July 28, 2005 Solvay completes acquisition of Fournier Pharma
Solvay announced today that it has completed the acquisition of 100% of Fournier Pharma, following the successful completion of social and regulatory procedures worldwide.
July 12, 2005 Solvay finalizes agreement to buy Fournier Pharma
Solvay announced today that it has signed a final purchase agreement with the shareholders of Fournier Pharma for the acquisition of 100% of the company.
June 30, 2005 MHRA requests further information on Cilansetron
MHRA requests further information on Cilansetron, Solvay ‘s proposed treatment for irritable bowel syndrome with diarrhea predominance (D-IBS)
March 16, 2005 Cetrorelix progresses to full development in Solvay Pharmaceuticals for the treatment of Endometriosis in women
SOLVAY PHARMACEUTICALS has decided to undertake full Phase III development with cetrorelix for the treatment of endometriosis in women.
February 17, 2005 Solvay Pharmaceuticals will supply Norway with special vaccines in the event of an influenza pandemic
Solvay Pharmaceuticals today announce that it has signed an agreement with the Norwegian authorities whereby Solvay Pharmaceuticals will supply influenza vaccines to Norway in the case of a pandemic.
February 03, 2005 Parkinson’s: Solvay Pharmaceuticals moves SLV 308 compound into phase III clinical development
SOLVAY PHARMACEUTICALS announces today it has advanced its R&D; project known under code name SLV308 into a full phase III development program
January 21, 2005 Solvay Pharmaceuticals completes acquisition of Neopharma in Sweden
SOLVAY PHARMACEUTICALS announces the successful completion of the acquisition of NEOPHARMA AB, a company based in Uppsala, Sweden, as shareholders representing 100% of the company’s capital accepted the friendly takeover bid launched by Solvay last December.