Recordati S.p.A. - Recordati files for approval of a new fixed combination product, lercanidipine+enalapril

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Recordati files for approval of a new fixed combination product, lercanidipine+enalapril

Milan, 9 December, 2004

Recordati announced that it has submitted a new drug application for a fixed combination of lercanidipine and enalapril with the BfArM, the German medicines agency. Following formal acceptance of the submission the review phase will commence. Assuming approval is obtained Germany will act as Reference Member State in the mutual recognition approval process for the rest of Europe.

The international guidelines for the treatment of hypertension establish new aggressive targets for blood pressure control in order to minimize the risk of severe cardiovascular events. Most hypertensive patients, especially those with other associated risk factors, now require multiple therapies using more than one drug to keep their blood pressure at desired levels. Associations of a calcium antagonist and an ACE inhibitor are frequently prescribed in such conditions.

Fixed combinations of more than one antihypertensive agent will therefore play a significant and increasing role in the future hypertension market. The advantages of fixed combinations as opposed to the administration of separate treatments are threefold: the combined dosages of the drugs are those broadly used by the physician and their efficacy and tolerability have been clinically proven, patient compliance - which is extremely important in chronic treatments aimed at reducing and preventing cardiovascular risk - is increased, and the cost of treatment is reduced. This latter advantage will play an important role in those countries where healthcare spending budgets are under pressure.

"The growing importance of fixed combination medication in the treatment of hypertension supports our decision to develop this product as part of the life cycle management of our flagship product lercanidipine", declared Dr. Avi Sartani, Director and VP of Research and Development. "A product based on a similar calcium antagonist + ACE inhibitor combination is widely used in the United States and we believe that products of this kind should also be successful in European markets in view of their therapeutic advantages and also from a pharma-economics point of view."

Recordati, established in 1926, is a European pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003074447), dedicated to the research, development, manufacturing and marketing of pharmaceuticals and pharmaceutical chemicals, with headquarters in Milan, Italy and operating subsidiaries in France, Ireland, Spain, Switzerland and the United States.

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Recordati at a glance Key Financial Data Recordati Share Press Releases 2012 2011 2010 2009 2008 2007 2006 2005 2004 2003 2002 2001 2000 Company Presentations Annual and Interim Reports Regulated information Shareholders’ Meetings Calendar Analyst Coverage Contacts	Press Releases Recordati files for approval of a new fixed combination product, lercanidipine+enalapril Milan, 9 December, 2004 Recordati announced that it has submitted a new drug application for a fixed combination of lercanidipine and enalapril with the BfArM, the German medicines agency. Following formal acceptance of the submission the review phase will commence. Assuming approval is obtained Germany will act as Reference Member State in the mutual recognition approval process for the rest of Europe. The international guidelines for the treatment of hypertension establish new aggressive targets for blood pressure control in order to minimize the risk of severe cardiovascular events. Most hypertensive patients, especially those with other associated risk factors, now require multiple therapies using more than one drug to keep their blood pressure at desired levels. Associations of a calcium antagonist and an ACE inhibitor are frequently prescribed in such conditions. Fixed combinations of more than one antihypertensive agent will therefore play a significant and increasing role in the future hypertension market. The advantages of fixed combinations as opposed to the administration of separate treatments are threefold: the combined dosages of the drugs are those broadly used by the physician and their efficacy and tolerability have been clinically proven, patient compliance - which is extremely important in chronic treatments aimed at reducing and preventing cardiovascular risk - is increased, and the cost of treatment is reduced. This latter advantage will play an important role in those countries where healthcare spending budgets are under pressure. "The growing importance of fixed combination medication in the treatment of hypertension supports our decision to develop this product as part of the life cycle management of our flagship product lercanidipine", declared Dr. Avi Sartani, Director and VP of Research and Development. "A product based on a similar calcium antagonist + ACE inhibitor combination is widely used in the United States and we believe that products of this kind should also be successful in European markets in view of their therapeutic advantages and also from a pharma-economics point of view." Recordati, established in 1926, is a European pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003074447), dedicated to the research, development, manufacturing and marketing of pharmaceuticals and pharmaceutical chemicals, with headquarters in Milan, Italy and operating subsidiaries in France, Ireland, Spain, Switzerland and the United States.