Recordati S.p.A. - Recordati's U.S. licensee, Forest, updates status of lercanidipine regulatory submission

Press Releases

Recordati's U.S. licensee, Forest, updates status of lercanidipine regulatory submission

Milan - 6 December 2002

Recordati's U.S. licensee, Forest Laboratories Inc. (NYSE: FRX) announced today that the U.S. Food and Drug Administration (FDA) will require it to conduct additional clinical trials in order to approve the dosing regimen of lercanidipine it had requested, which is the regimen in all 60 countries where lercanidipine is approved. In August Forest received an approvable letter for lercanidipine in which the FDA requested additional information.

Forest officials met with the FDA on December 4, 2002 to review their proposed response to the approvable letter. Forest believed its prepared response was adequate to support the proposed dosing regimen of the product, but was unable to persuade the agency. During the meeting the FDA asked for additional clinical data which Forest believes is likely to delay the potential approval and launch of lercanidipine, previously expected in the second half of 2003, by two years or longer. The current New Drug Application for lercanidipine retains its approvable status at the FDA. Forest remains committed to the commercialization of lercanidipine for the treatment of hypertension.

Lercanidipine is a next generation, long acting dihydropyridine calcium channel blocker for the treatment of hypertension, researched and developed by Recordati and licensed to Forest Laboratories for the U.S. market. Lercanidipine obtained its first marketing authorization, which was then extended to all European Union and to many non-European countries, in the United Kingdom in 1996. Lercanidipine is currently actively marketed in 42 countries with a growing trend in prescriptions and reputation with physicians and, as of last June, its use cumulatively accounted for over 15 million patient months.

"This delay in the commercialization of lercanidipine in the US market comes unexpected in a year which is otherwise the best in the history of Recordati. On the other hand, we are pleased with the progress of our product on markets worldwide. This is supported by a steady stream of favorable clinical data, including a recent major publication in the US " declared Giovanni Recordati, Chairman and CEO. " In addition, we confirm that our earnings target for this year will be met, while we will be presenting our updated prospects for future growth and guidance for 2003 - a year for which we expect profits which we deem satisfactory, although reduced with respect to our previous expectations - and beyond at the meeting with the financial community to be held in Milan on December 12, 2002."

For those interested, a conference call is scheduled at 14:30 Milan time, 13:30 London time, 8:30 EST. Call-in numbers are:
- from Italy, +39 02 8020911
- from the UK, +44 207 8664111
- from the USA, +1 412 8584600

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, Portugal, Spain, Switzerland and the United States.

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Shareholder information Recordati at a glance Key Financial Data Recordati Share Press Releases 2008 2007 2006 2005 2004 2003 2002 2001 2000 Company Presentations Annual and Interim Reports Calendar Analyst Coverage Contacts	Press Releases Recordati's U.S. licensee, Forest, updates status of lercanidipine regulatory submission Milan - 6 December 2002 Recordati's U.S. licensee, Forest Laboratories Inc. (NYSE: FRX) announced today that the U.S. Food and Drug Administration (FDA) will require it to conduct additional clinical trials in order to approve the dosing regimen of lercanidipine it had requested, which is the regimen in all 60 countries where lercanidipine is approved. In August Forest received an approvable letter for lercanidipine in which the FDA requested additional information. Forest officials met with the FDA on December 4, 2002 to review their proposed response to the approvable letter. Forest believed its prepared response was adequate to support the proposed dosing regimen of the product, but was unable to persuade the agency. During the meeting the FDA asked for additional clinical data which Forest believes is likely to delay the potential approval and launch of lercanidipine, previously expected in the second half of 2003, by two years or longer. The current New Drug Application for lercanidipine retains its approvable status at the FDA. Forest remains committed to the commercialization of lercanidipine for the treatment of hypertension. Lercanidipine is a next generation, long acting dihydropyridine calcium channel blocker for the treatment of hypertension, researched and developed by Recordati and licensed to Forest Laboratories for the U.S. market. Lercanidipine obtained its first marketing authorization, which was then extended to all European Union and to many non-European countries, in the United Kingdom in 1996. Lercanidipine is currently actively marketed in 42 countries with a growing trend in prescriptions and reputation with physicians and, as of last June, its use cumulatively accounted for over 15 million patient months. "This delay in the commercialization of lercanidipine in the US market comes unexpected in a year which is otherwise the best in the history of Recordati. On the other hand, we are pleased with the progress of our product on markets worldwide. This is supported by a steady stream of favorable clinical data, including a recent major publication in the US " declared Giovanni Recordati, Chairman and CEO. " In addition, we confirm that our earnings target for this year will be met, while we will be presenting our updated prospects for future growth and guidance for 2003 - a year for which we expect profits which we deem satisfactory, although reduced with respect to our previous expectations - and beyond at the meeting with the financial community to be held in Milan on December 12, 2002." For those interested, a conference call is scheduled at 14:30 Milan time, 13:30 London time, 8:30 EST. Call-in numbers are: - from Italy, +39 02 8020911 - from the UK, +44 207 8664111 - from the USA, +1 412 8584600 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, Portugal, Spain, Switzerland and the United States.