Recordati S.p.A. - Recordati: lercanidipine N.D.A. filed in the U.S.

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Recordati: lercanidipine N.D.A. filed in the U.S.

Milan, 2 October 2001

Recordati announced the filing today of the New Drug Application (NDA) with the Food and Drug Administration for lercanidipine, a calcium channel blocker discovered and developed by Recordati, indicated in the treatment of hypertension.

The NDA was filed by Forest Laboratories (NYSE:FRX), Recordati's licensee for the U.S. market, with which Recordati collaborated in the preparation of the dossier. The F.D.A. technically requires about one year for the review of applications similar to that for lercanidipine.

The U.S. pharmaceutical market represents about 40% of the world total pharmaceutical market. Hypertension is a widespread condition which affects over 50 million Americans. Antihypertensives are one of the main segments of this market with annual sales of over 12 billion dollars. Lercanidipine belongs to one of the most prescribed classes of antihypertensive drugs.

Howard Solomon, Chairman and Chief Executive Officer of Forest Laboratories stated, "Lercanidipine has certain distinct characteristics which we believe will enable it to achieve a significant position in the hypertension market. Our partnership with Recordati is another of the highly successful partnerships we have established with specialized, innovative companies in Europe who need a strong marketing partner in the United States."

"We are very pleased to have reached such an important stage in the international development of lercanidipine" - declared Giovanni Recordati, Chairman - "To date our proprietary drug is approved in 34 countries, is on the market in 28 of these and has been filed for approval in a further 45, including the U.S.A. which is the world largest pharmaceutical market. Forest Laboratories, a very successful company on the U.S. market, has proven to be an excellent partner and has also very competently handled the preparation phase of the NDA for our drug."

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, Portugal, 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: lercanidipine N.D.A. filed in the U.S. Milan, 2 October 2001 Recordati announced the filing today of the New Drug Application (NDA) with the Food and Drug Administration for lercanidipine, a calcium channel blocker discovered and developed by Recordati, indicated in the treatment of hypertension. The NDA was filed by Forest Laboratories (NYSE:FRX), Recordati's licensee for the U.S. market, with which Recordati collaborated in the preparation of the dossier. The F.D.A. technically requires about one year for the review of applications similar to that for lercanidipine. The U.S. pharmaceutical market represents about 40% of the world total pharmaceutical market. Hypertension is a widespread condition which affects over 50 million Americans. Antihypertensives are one of the main segments of this market with annual sales of over 12 billion dollars. Lercanidipine belongs to one of the most prescribed classes of antihypertensive drugs. Howard Solomon, Chairman and Chief Executive Officer of Forest Laboratories stated, "Lercanidipine has certain distinct characteristics which we believe will enable it to achieve a significant position in the hypertension market. Our partnership with Recordati is another of the highly successful partnerships we have established with specialized, innovative companies in Europe who need a strong marketing partner in the United States." "We are very pleased to have reached such an important stage in the international development of lercanidipine" - declared Giovanni Recordati, Chairman - "To date our proprietary drug is approved in 34 countries, is on the market in 28 of these and has been filed for approval in a further 45, including the U.S.A. which is the world largest pharmaceutical market. Forest Laboratories, a very successful company on the U.S. market, has proven to be an excellent partner and has also very competently handled the preparation phase of the NDA for our drug." 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, Portugal, Spain, Switzerland and the United States.