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SpePharm announces the granting of national marketing authorizations for Loramyc in Europe and ...


Amsterdam, The Netherlands, 5 June 2008 –SpePharm Holding B.V., the specialty pharmaceutical company dedicated to the sales and marketing of innovative hospital and specialists products throughout Europe, today announced the granting of national approvals of Loramyc® in the UK, Denmark, Germany, Belgium, The Netherlands, Luxembourg, Finland and Sweden, as well as in Spain under the trade name Sitamic®. Loramyc® 50mg, a muco-adhesive buccal tablet of miconazole, is indicated for the treatment of oropharyngeal candidiasis (OPC) in immuno-compromised patients. At the same time, Loramyc® has been launched in the UK and will be promoted in the secondary care setting mostly to cancer and HIV/AIDS patients suffering from OPC.

Jean-François Labbé, President and CEO of SpePharm commented:
“Following marketing approval and this initial launch in the UK, further launches of Loramyc will follow as other national marketing authorisations are granted, and SpePharm continues to aggressively put in place its sales and marketing infrastructure throughout Europe”.

Mike Stowe, SpePharm UK Ltd Managing Director added:
“We all feel very positive about the UK launch of Loramyc as the initial feedback from specialists indicates a real need for this product due to the lack of optimal efficacy and compliance issues with currently available products. Although guidelines recommend the first line use of a topical buccal treatment for OPC, in many cases specialists are being forced to move immediately to systemic drugs with the attendant risks of generating both resistance and potentially severe drug-drug interactions. We believe that Loramyc is the only topical, once-daily, effective treatment for OPC in this important group of immuno-compromised patients.”

-end-

Media contact:

SpePharm Holding BV
Jean-François Labbé
Managing Director
Tel: +33 (0)1 56 60 52 46
jean-francois.labbe@spepharm.com

College Hill Life Sciences
Douglas Pretsell
Account Director
Tel: +49 (0)89 57 00 18 06
douglas.pretsell@collegehill.com

About SpePharm Holding, B.V.

SpePharm Holding, B.V. is a Dutch company with its registered office in Amsterdam, and its European operations based in Paris, France. SpePharm is an emerging pan-European specialty pharmaceutical company focused on acquiring, registering and marketing high medical value specialty medicines essentially for the hospital markets. Particular areas of therapeutic interest are oncology, critical and supportive care. SpePharm aims to be the preferred partner for pharmaceutical and biotechnology companies, especially those from outside of Europe, seeking to maximize product and commercial opportunities within Europe. SpePharm was founded in September 2006 by Jean-François Labbé together with leading life science investment firms TVM Capital and Signet Healthcare Partners (part of the Sanders Morris Harris Group). Jean-François Labbé is a former top executive of Hoechst Marion Roussel and Parke Davis with over 30 years of experience in international pharmaceutical management. SpePharm, through its founding management team, has a proven track record of successful development, registration, and commercialization of quality therapeutic products in supportive & critical care, oncology and in orphan diseases. To date SpePharm has an established commercial presence in the UK, Germany, Italy, Benelux and the Nordic area.

About Loramyc®

Loramyc®, muco-adhesive buccal tablets containing miconazole (50 mg), provides an innovative delivery system for the product which was developed by BioAlliance Pharma S.A. for the treatment of oropharyngeal candidiasis (OPC) in immuno-compromised patients. In October 2006, BioAlliance obtained a marketing authorization for Loramyc® in France. In December 2007, the product obtained regulatory approval across Europe under the European Mutual Recognition Procedure (MRP) with France as the Reference Member State. To date national approvals have been granted in the UK, Denmark, Germany, Belgium, The Netherlands, Finland, Luxembourg and Sweden under the trade name Loramyc®, as well as in Spain under the trade name Sitamic®. National approval processes are ongoing in the other European countries involved in the MRP.

For more information about SpePharm, please visit the web site at www.spepharm.com


Publisher Contact Information:

SpePharm Holding, B.V.
+33 (0)1 56 60 52 46
jean-francois.labbe@spepharm.com

Company profile of SpePharm Holding, B.V.
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