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Microsoft word - 20060719_synordia_en.doc
Embargo : July 19, 2006 at 8:30AM (Brussels time)
SOLVAY SUBMITS SYNORDIA®
( FENOFIBRATE/ METFORMIN) FOR EU APPROVAL
Building out the fenofibrate franchise with a new fixed-dose combination product
Solvay announced today that it has submitted its dossier for SYNORDIA®1 to the European Medicines Evaluation Agency on 17 July 2006 for a centralized approval procedure. SYNORDIA® is a fenofibrate/metformin fixed-dose combination product. It would be the first product on the market that combines a lipid lowering drug with an oral antidiabetic in one pill, targeting increased patient convenience and improved compliance for patients already stabilized on the two medications, fenofibrate and metformin which can control both the blood lipids and blood glucose of patients. The clinical Phase III program, carried out in more than 1000 patients, demonstrated that SYNORDIA® is efficacious and is well accepted. Previous trials (DAIS and FIELD) have also indicated that the combination therapy of fenofibrate/metformin has benefits for type 2 diabetic patients. “SYNORDIA® would represent a valuable treatment option for many type 2 diabetic patients, improving the quality of life for many men and women who struggle with this disease on a daily basis. It reduces the number of tablets they need to take each day. Moreover, it is an important addition to the range of fenofibrate treatments we offer”, said Werner Cautreels, CEO of Solvay Pharmaceuticals.
is a research driven group of companies that constitute the global pharmaceutical
business of the Solvay Group. The company seeks to fulfill carefully selected, unmet medical needs in the
therapeutic areas of neuroscience, cardio-metabolic, influenza vaccines, gastroenterology, specialized markets
and men’s and women’s health. Its 2005 sales were EUR 2.3 billion and it employs approximately 10,000
people worldwide. For more information, visit www.solvaypharmaceuticals.com. SOLVAY
is an international chemical and pharmaceutical Group with headquarters in Brussels. It employs
some 30,000 people in 50 countries. In 2005 its consolidated sales amounted to EUR 8.6 billion generated by
its three activity sectors: Chemicals, Plastics and Pharmaceuticals. SOLVAY (Euronext : SOLB.BE -
Bloomberg: SOLB.BB - Reuters: SOLB.BR) is listed on the Euronext stock exchange in Brussels. Details are
available at www.solvay.com
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Notes to the editor:
DAIS = Diabetes Atherosclerosis Intervention Study (2001),418 patients received treatment with fenofibrate (or
placebo) for 3 years. The study gave first evidence that fenofibrate could prevent cardiovascular
morbidity/mortality in type 2 diabetes patients.
FIELD = Fenofibrate Intervention and Event Lowering in Diabetes in 9795 patients (2005), about one third
receiving fenofibrate (or placebo) and metformin.
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1 Formerly known under the project name Dualthys
INFORMED CONSENT DOCUMENT FOR TREATMENTS WITH MACROLANE™ VRF20 AND MACROLANE™ VRF30FIRST AND SURNAME OF THE PATIENT’S LEGAL REPRESENTATIVE LEGAL REPRESENTATIVE, RELATIVE, LEGAL GUARDIAN) I STATE THAT NAME OF THE DOCTOR WHO GIVES THE INFORMATIONN° OF MEMBER OF THE PROFESSIONAL BODY (IF APPLICABLE) has explained to me that in my situation it is advised that I be treated with Macrolan
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