SOURCE: Recordati

April 21, 2008 12:29 ET

Recordati: Orphan Europe Filed Carbaglu NDA With the FDA in the U.S.

MILAN, ITALY--(Marketwire - April 21, 2008) - Recordati announced the submission to the U.S. FDA by Orphan Europe (a Recordati group company) of an Original New Drug Application (NDA) for Carbaglu® (carglumic acid). The NDA provides for the safe and effective use of Carbaglu® in the treatment of hyperammonaemia due to an autosomal genetic disorder resulting in the deficiency of the liver enzyme N-acetylglutamate synthase (NAGS deficiency).

NAGS deficiency, a very rare disease involving extremely high plasma levels of ammonia, which leads to permanent and irreversible damage of the central nervous system, is a lifelong serious life-threatening clinical condition. 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.

In Europe, where sales in 2008 are expected to be of around EUR 6 million, Carbaglu® was granted Orphan Drug status in 2000. The product was granted Orphan Drug status in the USA in 1998 and the FDA granted Carbaglu® a Fast Track designation in May 2007 as it is intended to treat a serious or life-threatening condition and address an unmet medical need.

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 2,400. A European field force of over 1,300 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 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.

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