DGAP-News: Sanochemia Pharmazeutika AG: European Marketing Authorisation for MRT Imaging Agent
(firmenpresse) - Sanochemia Pharmazeutika AG / Regulatory Approval
10.03.2010 08:40
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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
listed in Vienna announces that the European phase of the decentralised
procedure (DCP) for the registration of Magnetolux(R), for use in magnetic
resonance tomography, has been successfully completed. The German
regulatory authority BfArM 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(R) 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(R). Through the
awarding of national marketing authorisations for Magnetolux(R), Sanochemia
aims to rapidly consolidate its position as a European provider of a full
range of imaging agents. Following Scanlux(R), Sanochemia's internationally
successful radiological product, Magnetolux(R) 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% from the MRT market, approximately equivalent to revenues of 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(R) 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.
Margarita Hoch
Investor Relations
phone: +43 / 1 / 3191456 /335
fax: +43 / 1 / 3191456/ 344
m.hoch(at)sanochemia.at
10.03.2010 08:40 Ad hoc announcement, Financial News and Media Release distributed by DGAP. Medienarchiv atwww.dgap-medientreff.deandwww.dgap.de---------------------------------------------------------------------------
Language: English
Company: Sanochemia Pharmazeutika AG
Boltzmanngasse 9a - 11
A-1091 WienÖsterreich
Phone: +43 (1) 319 14 56-0
Fax: +43 (1) 319 14 56-44
E-mail: office(at)sanochemia.at
Internet: www.sanochemia.at
ISIN: AT0000776307
WKN: 919963
Indices: Prime Standard
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehrin Berlin, München, Düsseldorf, Stuttgart, Hamburg
End of News DGAP News-Service
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Datum: 10.03.2010 - 02:40 Uhr
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