milan : REC

May 31, 2011 09:28 ET

Recordati: Approval Granted for the Use of Carbaglu® in the Treatment of Organic Acidaemias

MILAN, ITALY--(Marketwire - May 31, 2011) -

Recordati announces that its wholly-owned subsidiary OrphanEurope has received an approval from the European Commission (Directorate health systems and products) to extend the use of Carbaglu®(carglumic acid) to treat hyperammonaemia due to one of the three main organic acidaemias (isovaleric acidaemia, methylmalonic acidaemia or propionic acidaemia). Carbaglu® has orphan drug designation and since 2003 is indicated in the treatment of NAGS deficiency.

Organic acidaemias (OA) are usually diagnosed in infancy. These rare disorders vary in their prognosis, from manageable to fatal, and usually affect more than one organ system, especially the central nervous system. Organic acidaemias are a group of inherited rare metabolic disorders which disrupt physiologic amino acid degradation causing a build-up of organic acids, which in turn may inhibit the urea cycle function, leading to hyperammonaemia. It is estimated that there are about 800 patients suffering from hyperammonaemia due to those three OAs in Europe.

The acute hyperammonaemia due to OA represents a true medical emergency and its management is usually performed in intensive care units. The main goal of emergency treatment is to reduce ammonia levels and thus prevent brain damage. Carbaglu® restores the urea cycle and thus reduces blood ammonia level. Orphan Europe has performed a retrospective analysis on 57 patients to analyze the effect of Carbaglu® on hyperammonaemia in patients with OAs. The study has shown that oral administration of Carbaglu® is rapidly effective in decreasing hyperammonaemia and stabilising clinical symptoms. These data analysis led to the approval of extended indications for Carbaglu®.

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),with a total staff of over 2,800, 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 around 1,400 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 2010 was EUR 728.1 million, operating income was EUR 154.8 million and net income was EUR 108.6 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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Source: RECORDATI via Thomson Reuters ONE


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