Simvastatin is produced by chemical synthesis from lovastatin, which is a fermentation product isolated from the strain Aspergillus terreus. Simvastatin is currently marketed as Zocor®, by Merck & Co. and was the first prescription drug in worldwide sales in 2001 ($US 6670 millions). The markets of United States, France, Germany, United Kingdom and Japan together account for 58 tons of API annual consumption ($ 4868 millions of prescription drug sales).

The original patent expired in 2001, but a Supplementary Protection Certificate (SPC) was granted in most of the countries. The validity of the patent was extended to 2003 in Germany and in the United Kingdom and to 2005 in France and in the United States. In Portugal the patent expired in February 2002.

Hovione entered into a joint collaboration agreement with Chong Kun Dang (CKD Bio), the Korean fermentation specialist to produce and market simvastatin worldwide. Also, we are preparing the registration filings of simvastatin tablets generic to Zocor®, according to European and United States regulatory requirements.

This strategic integration of fermentation and chemical synthesis skills put us in an excellent position to offer reliability of supply, competitiveness, flexibility and complete support from the API sourcing to the registration file.

For further information please contact us:

Marketing and Sales Department
Tel: + 351 21 9829245
Fax: + 352 21 9829388
email –