Recordati: Zan-Extra(R) Approved In Australia

Main Category: Hypertension
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 20 Feb 2008 - 3:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Recordati announced the approval of Zan-Extra(R), a fixed combination of lercanidipine and enalapril indicated for the treatment of hypertension, in Australia. The Australian Register of Therapeutic Goods (ARTG) communicated its decision to approve the registration submitted by licensee Solvay Biosciences of Zan-Extra® in its two dosage forms containing lercanidipine 10mg/enalapril 10mg and lercanidipine 10mg/enalapril 20mg. The launch in Australia of this new product originated by Recordati is planned to take place in April.

"This approval in Australia represents a further significant step in the development of our new antihypertensive product following its launch in Germany in 2007", declared Giovanni Recordati, Chairman and CEO. "Lercanidipine, with a share of 23%, is already a successful product in this market, which for our product represents the fourth largest worldwide and first outside Europe, and can improve even further thanks to the new combination treatment" continued Giovanni Recordati. "We are expecting the outcome of the Mutual Recognition Procedure in Europe shortly and this will allow us to launch the product throughout the European Union."

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 2,200. A European field force of over 1,100 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 2007 was EUR 628.4 million, operating income was EUR 131.5 million and net income was EUR 84.9 million.

Statements contained in this release, other than historical facts, are "forward-looking statements" (as such term is defined in the Private Securities Litigation Reform Act of 1995). These statements are based on currently available information, on current best estimates, and on assumptions believed to be reasonable. This information, these estimates and assumptions may prove to be incomplete or erroneous, and involve numerous risks and uncertainties, beyond the Company's control. Hence, actual results may differ materially from those expressed or implied by such forward-looking statements. All mentions and descriptions of Recordati products are intended solely as information on the general nature of the company's activities and are not intended to indicate the advisability of administering any product in any particular instance.

http://www.recordati.com