Recordati S.p.A. - Recordati licenses once-daily tramadol from Labopharm for exclusive marketing in the United Kingdom

Press Releases

Recordati licenses once-daily tramadol from Labopharm for exclusive marketing in the United Kingdom

Milan, 16 November, 2005

Recordati announced that it has entered into a license agreement with Labopharm, a Canadian based pharmaceutical group, for the exclusive marketing and sale in the United Kingdom of a once-daily tramadol tablet formulation incorporating Contramid®, Labopharm's proprietary advanced controlled-release technology. Tramadol is a widely used, centrally acting, opioid analgesic medicine indicated for the management of moderate to severe pain. The product has completed positively its review process in the UK via an MRP (Mutual Recognition Process) and the marketing authorization is expected shortly. The launch on the UK market by Recordati's subsidiary Recordati Pharmaceuticals Ltd. is therefore expected to take place in the first half of 2006.

Pain management is a large market as pain afflicts millions of people worldwide but the condition is generally under-treated. There is a growing need for safer analgesics for patients who require treatment for moderate to severe pain. Tramadol provides powerful relief from many kinds of pain including osteoarthritis pain, low back pain, cancer pain, post-operative pain and dental pain. A once-a-day tramadol, such as Labopharm's product, is an attractive and safe treatment option that provides patients with strong and reliable 24-hour pain relief.

The UK is the third largest European market for tramadol products by dollar sales. Demand for tramadol products in the UK reached more than US$ 104 million for the 12 months ended June 2005 and has grown at a compound annual growth rate of 17% over the five preceding 12-month periods.

"We are very pleased with our agreement with Labopharm and the opportunity of selling an innovative formulation of a well-known product of this kind in a major market" declared Giovanni Recordati, Chairman and CEO. "The once-daily tramadol license is in line with our plan to grow our newly established subsidiary in the UK through the acquisition of new licenses in addition to the sales development of our proprietary antihypertensive calcium channel blocker lercanidipine and other future products from our pipeline."

About Labopharm
Labopharm Inc. is a publicly traded (TSX:DDS) international, specialty pharmaceutical company focused on the development of drugs incorporating Contramid , the Company's proprietary advanced controlled-release technology. Labopharm's lead product, a once-daily formulation of the analgesic tramadol, has received regulatory approval in 22 European countries. In the U.S., where the Company is planning to file an NDA for once-daily tramadol before the end of 2005, it has secured a licensing and distribution agreement with Purdue Pharma L.P., the premier marketer of long-acting pain medications in that country. The Company's pipeline includes a combination of in-house and partnered programs with products in both clinical trials and preclinical development.

About Recordati
Recordati, established in 1926, is a European pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003828271), dedicated to the research, development, manufacturing and marketing of pharmaceuticals, with headquarters in Milan, Italy, operations in the main European countries, and a total staff of over 2,000. A European field force of over 1,000 medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in a number of therapeutic areas. Recordati's current and growing coverage of the European pharmaceutical market makes it a partner of choice for new product licenses from companies which do not have European marketing organizations. Recordati is committed to the research of new drug entities within the cardiovascular and urogenital therapeutic areas in which its research team has proven scientific competence and a track record of discovery and development of original drugs, the most recent of which, lercanidipine, a latest generation calcium channel blocker for the treatment of hypertension, is the company's leading product. Consolidated revenue for 2004 was € 488.3 million, operating income was € 90.4 million and net income was € 54.0 million.

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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 licenses once-daily tramadol from Labopharm for exclusive marketing in the United Kingdom Milan, 16 November, 2005 Recordati announced that it has entered into a license agreement with Labopharm, a Canadian based pharmaceutical group, for the exclusive marketing and sale in the United Kingdom of a once-daily tramadol tablet formulation incorporating Contramid®, Labopharm's proprietary advanced controlled-release technology. Tramadol is a widely used, centrally acting, opioid analgesic medicine indicated for the management of moderate to severe pain. The product has completed positively its review process in the UK via an MRP (Mutual Recognition Process) and the marketing authorization is expected shortly. The launch on the UK market by Recordati's subsidiary Recordati Pharmaceuticals Ltd. is therefore expected to take place in the first half of 2006. Pain management is a large market as pain afflicts millions of people worldwide but the condition is generally under-treated. There is a growing need for safer analgesics for patients who require treatment for moderate to severe pain. Tramadol provides powerful relief from many kinds of pain including osteoarthritis pain, low back pain, cancer pain, post-operative pain and dental pain. A once-a-day tramadol, such as Labopharm's product, is an attractive and safe treatment option that provides patients with strong and reliable 24-hour pain relief. The UK is the third largest European market for tramadol products by dollar sales. Demand for tramadol products in the UK reached more than US$ 104 million for the 12 months ended June 2005 and has grown at a compound annual growth rate of 17% over the five preceding 12-month periods. "We are very pleased with our agreement with Labopharm and the opportunity of selling an innovative formulation of a well-known product of this kind in a major market" declared Giovanni Recordati, Chairman and CEO. "The once-daily tramadol license is in line with our plan to grow our newly established subsidiary in the UK through the acquisition of new licenses in addition to the sales development of our proprietary antihypertensive calcium channel blocker lercanidipine and other future products from our pipeline." About Labopharm Labopharm Inc. is a publicly traded (TSX:DDS) international, specialty pharmaceutical company focused on the development of drugs incorporating Contramid , the Company's proprietary advanced controlled-release technology. Labopharm's lead product, a once-daily formulation of the analgesic tramadol, has received regulatory approval in 22 European countries. In the U.S., where the Company is planning to file an NDA for once-daily tramadol before the end of 2005, it has secured a licensing and distribution agreement with Purdue Pharma L.P., the premier marketer of long-acting pain medications in that country. The Company's pipeline includes a combination of in-house and partnered programs with products in both clinical trials and preclinical development. About Recordati Recordati, established in 1926, is a European pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003828271), dedicated to the research, development, manufacturing and marketing of pharmaceuticals, with headquarters in Milan, Italy, operations in the main European countries, and a total staff of over 2,000. A European field force of over 1,000 medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in a number of therapeutic areas. Recordati's current and growing coverage of the European pharmaceutical market makes it a partner of choice for new product licenses from companies which do not have European marketing organizations. Recordati is committed to the research of new drug entities within the cardiovascular and urogenital therapeutic areas in which its research team has proven scientific competence and a track record of discovery and development of original drugs, the most recent of which, lercanidipine, a latest generation calcium channel blocker for the treatment of hypertension, is the company's leading product. Consolidated revenue for 2004 was € 488.3 million, operating income was € 90.4 million and net income was € 54.0 million.