RECORDATI : LE CARBAGLU® AGRÉÉ PAR LA FDA POUR UTILISATION AUX ÉTATS-UNIS.

Milan, le 19 mars 2010 - Recordati annonce que la FDA (Food and Drug Administration) a approuvé la demande d'autorisation de mise sur le marché américain du Carbaglu® (acide carglumique), qui a été soumise par Orphan Europe, pour le traitement de l'hyperammoniémie aiguë de l'enfant et de l'adulte causée par un déficit de l'enzyme hépatique N-acétyl glutamate synthase (déficit en NAGS) ainsi que comme traitement d'entretien pour l'hyperammoniémie aiguë causée par un déficit en NAGS.


Le déficit en NAGS, une maladie extrêmement rare se distinguant par des niveaux d'ammoniaque très élevés dans le plasma sanguin, entraînant des dommages permanents et irréversibles au système nerveux central, est une condition clinique grave mettant en danger la vie du patient. The symptoms start shortly after birth, rapidly leading to cerebral oedema, coma and eventually death without appropriate treatment. Rapid diagnosis and prompt effective treatment are essential to prevent patients from permanent neurological damage.

Carbaglu® is the only specific treatment of hyperammonaemia due to NAGS deficiency. Other available treatments are unspecific for this indication. When treatment with Carbaglu® is started early, patients have normal growth and neurological development, and most of them do not need protein dietary restrictions. Carbaglu® does not only save patients' lives, but also assures a good quality of life for patients on a continuous treatment.

"We are very pleased with the FDA's timely decision to approve Carbaglu® and thus make this drug available for patients in the U.S. suffering from such a serious condition" stated Giovanni Recordati, Chairman and CEO. "This also represents a significant step in the development of our business dedicated to the treatment of rare and orphan diseases."
Recordati, established in 1926, is a European pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003828271),with a total staff of over 2,950, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. It has headquarters in Milan, Italy, operations in the main European countries, and a growing presence in the new markets of Central and Eastern Europe. A European field force of over 1,450 medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in a number of therapeutic areas including a specialized business dedicated to treatments for rare diseases. 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 and development of new drug entities within the cardiovascular and urogenital therapeutic areas and of treatments for rare diseases. Consolidated revenue for 2009 was E 747.5 million, operating income was E 162.2 million and net income was E 110.6 million.

For further information:

Recordati website: www.recordati.com

Investor Relations
Marianne Tatschke
(39)0248787393
e-mail: [email protected]

Media Relations
Claudio Rossetti (Echo Comunicazione d'Impresa)
(39)02 62694736
e-mail: [email protected]

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.



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