Solvay Pharmaceuticals announced today that it has obtained European marketing approval for its new cardiovascular combination drug TEVETEN® PLUS. This European registration follows the completion of a Mutual Recognition Procedure (MRP), with Germany - where the drug was launched in November 2002 - acting as Reference Member State. Our MRP means that the following 13 EU member states and associated countries will now grant a marketing authorization to TEVETEN® PLUS: Austria, Belgium, Denmark, Finland, Greece, Iceland, Ireland, Italy, Luxembourg, Portugal, Spain, Norway and Sweden. The drug, a fixed combination tablet, will be launched first in Denmark in September 2004, with other countries launching the product later this year or in 2005.
Separately, registration has been recently obtained in Canada, where TEVETEN® PLUS was launched on 6 July 2004.
TEVETEN® PLUS is a combination tablet of 600 mg eprosartan and 12,5 mg hydrochlorothiazide, a diuretic which contributes to a stronger blood pressure lowering activity. TEVETEN® PLUS is used to treat hard-tocontrol hypertension - particularly systolic hypertension, which is becoming a well established predictor of cardiovascular risk. Untreated hypertension can put people at risk for serious cardiovascular events, such as kidney failure, heart attack and stroke. It is a once a day antihypertensive therapy with a simple dose regimen mainly targeted to patients over 50. TEVETEN® (eprosartan mesylate), an angiotensin-II-receptor antagonist, belongs to the latest generation of antihypertensives.
Coos de Graaf, Head of Global Marketing, says “This is an important business opportunity for us in a growing market for hypertension. We expect TEVETEN® PLUS to contribute significantly to our cardiology marketing and sales activities”. Solvay Pharmaceuticals believes that the addition of sales of the combination tablet to sales of TEVETEN alone gives the company new approaches to realizing the full potential of this product, which is estimated to be in Solvay Pharmaceuticals’ EUR 100-to-250 million peak annual sales category. Cardiovascular diseases are the leading cause of death in the western world. The hypertension market is one of the largest single pharmaceuticals markets in the world.
Solvay Pharmaceuticals is the pharmaceutical activities arm of Solvay. It is a research-driven pharmaceutical company that seeks to fulfill carefully selected, unmet medical needs in the therapeutic areas of cardiology, gastroenterology, mental health, and gynecology/andrology. Solvay Pharmaceuticals employs more than 7500 people worldwide.
Solvay is an international chemicals and pharmaceuticals group with headquarters in Brussels. It employs more than 30,000 people in 50 countries. In 2003 its consolidated sales amounted to EUR 7.6 billion generated by its three activity sectors: Chemicals, Plastics and Pharmaceuticals. Solvay is listed on the Euronext 100 index of top European companies. Details are available at www.solvay.com.
