2008-05-07

Astellas' Mycamine(R) (micafungin) Licensed for Use in Europe to Treat Serious Fungal Infections


Staines, England (ots/PRNewswire) - The European MedicinesAgency (EMEA) has announced the marketing authorisation ofMycamine(R), Astellas Pharma Europe's treatment for invasivecandidiasis, oesophageal candidiasis and prophylaxis of Candidainfection in patients undergoing allogeneic haematopoietic stem celltransplantation. Mycamine(R) will initially be available in the U.Kand across the European market shortly after this.

Professor David Denning of The University of Manchester said ofthe announcement: "The approval of micafungin is very good news forpatients with life-threatening fungal infections in Europe. TheCompany has conducted a number of large, high quality clinicalstudies in Candida infections with impressive results. Particularlywelcome are the indications for fungal infections in children andbabies, often a neglected group in the early drug approval process."

The efficacy and safety of Mycamine(R) have been demonstrated ina clinical development programme including more than 3,500 patientsin 16 clinical trials. The trials included nearly 300 children.Mycamine(R) was launched in Japan in 2002 and in the US three yearsago. In these two major markets more than 350,000 patients have beentreated with the product.

"We are delighted that Mycamine(R) is now licensed for use inEurope," said Alan Houston, MBBS, MRCP, FFPM, Senior Vice President,Research and Development, Astellas Pharma Europe. "It means thatdoctors will now have a new option to treat both their adult andpaediatric - including neonatal - patients with."

Recognising the increasing need for new products to fight thegrowing epidemic caused by healthcare associated infections, Astellasis committed to building a strong anti-infectives franchise. This isreflected by its extensive clinical trial programme which has beenvery positively received by key opinion leaders in the area.

Notes to Editors

Mycamine

The indications for adults, adolescents 16 years of age or olderand elderly are: Treatment of invasive candidiasis; Treatment ofoesophageal candidiasis in patients for whom intravenous therapy isappropriate; Prophylaxis of Candida infection in patients undergoingallogeneic haematopoietic stem cell transplantation or patients whoare expected to have neutropenia (absolute neutrophil count < 500cells / microlitre) for 10 or more days. For children (includingneonates) and adolescents <16 years of age, Mycamine is indicatedfor: Treatment of invasive candidiasis; Prophylaxis of Candidainfection in patients undergoing allogeneic haematopoietic stem celltransplantation or patients who are expected to have neutropenia(absolute neutrophil count <500 cells / microlitre) for 10 or moredays.

Astellas Pharma Europe Ltd.

Astellas Pharma Europe Ltd., located in the UK, is a Europeansubsidiary of Tokyo-based Astellas Pharma Inc. Astellas is apharmaceutical company dedicated to improving the health of peoplearound the world through the provision of innovative and reliablepharmaceutical products. The organisation is committed to becoming aglobal category leader by combining outstanding R&D and marketingcapabilities and continuing to grow in the world pharmaceuticalmarket. In Europe, Astellas markets products in the areas ofImmunology, Urology, Dermatology and Cancer. Astellas Pharma Europehas 20 affiliate offices located across Europe, the Middle East andAfrica, one R&D site and three manufacturing plants with nearly 3000staff.

Astellas Pharma Europe Ltd., Lovett House, Lovett Road,Staines, Middlesex TW18 3AZ

For more information please contact: Mindy Dooa Astellas Pharma Europe Tel: +44(0)1784-419-408 Email: mindy.dooa@eu.astellas.com Rosie Allan Red Door Communications Tel: +44(0)20-8392-6931 Email: rallan@rdcomms.com Jas Kaur Red Door Communications Email: jkaur@rdcomms.com

ots Originaltext: Astellas Pharma Europe LimitedIm Internet recherchierbar: http://www.presseportal.de

Contact:For more information please contact: Mindy Dooa, Astellas Pharma Europe, Tel: +44(0)1784-419-408, Email: mindy.dooa@eu.astellas.com; Rosie Allan, Red Door Communications, Tel: +44(0)20-8392-6931, Email:rallan@rdcomms.com; Jas Kaur, Red Door Communications, Email: jkaur@rdcomms.com

Astellas Pharma Europe Limited

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Astellas' Mycamine(R) (micafungin) Licensed for Use in Europe to Treat Serious Fungal Infections

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