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• European DCP phase completed
• Launches in Europe’s most important markets within a year
Vienna, 10 February 2010 – Sanochemia Pharmazeutika AG, Vienna, listed in the Prime Segment of the Frankfurt Stock Exchange (ISIN AT0000776307) and in Vienna, announces that the European phase of the decentralised procedure (DCP) for the registration of Magnetolux®, for use in magnetic resonance tomography, has been successfully completed. The German regulatory authority BfArM[1] oversaw and approved the DCP in the role of the reference member state, therefore paving the way for the start of the national phase of marketing authorisations for Magnetolux® in the 13 countries taking part in the registration procedure. In due course, Sanochemia expects to receive the national marketing authorisations in Europe’s largest and most important markets, such as Spain, Italy and the UK, within the space of a year. Intensive preparatory marketing work is already ongoing, with product launches via marketing partners planned to take place successively, the majority in 2010/2011.
Sanochemia’s MRT imaging agent is already successfully distributed in Germany and Switzerland under the brand name MR-Lux®. Through the awarding of national marketing authorisations for Magnetolux®, Sanochemia aims to rapidly consolidate its position as a European provider of a full range of imaging agents. Following Scanlux®, Sanochemia’s internationally successful radiological product, Magnetolux® represents a further high-potential product with excellent chances of being marketed throughout Europe in the near future.
Within a year of the European launches of this product, Sanochemia expects to see sales figures on a par with those seen in Germany and Switzerland. In the mid term, the Company aims to secure a market share of around 5% to 10% of a market which generates revenues of around 300 million euro in Europe. With double-digit growth rates, the MRT market is the fastest growing segment of the market for imaging agents. In addition to its own marketing activities, the Company also acts as a contract manufacturer for the active substance for use in customer-specific formulations for the entire European market. This clearly underlines Sanochemia’s comprehensive expertise in the development and manufacture of diagnostics. The production processes for imaging agents developed by Sanochemia at its Neufeld site give the Company a decisive competitive advantage.
Magnetolux® is a so-called paramagnetic imaging agent for magnetic resonance tomography (MRT) of the entire body and is also used in the early identification and diagnosis of tumours and inflammation. This is particularly important because early diagnosis following suspected tissue changes or the growth of metastases enables patients to receive appropriate treatments in good time. A further application area is the imaging of vessels (angiography). Diseases affecting blood and other vessels are a common cause of often fatal conditions in industrialised nations.
[1] Bundesinstitut für Arzneimittel und Medizinprodukte = Federal Insitute for Drugs and Medical Devices
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