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Astellas Pharma Europe Limited

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

Staines, England (ots/PRNewswire)

The European Medicines
Agency (EMEA) has announced the marketing authorisation of
Mycamine(R), Astellas Pharma Europe's treatment for invasive
candidiasis, oesophageal candidiasis and prophylaxis of Candida
infection in patients undergoing allogeneic haematopoietic stem cell
transplantation. Mycamine(R) will initially be available in the U.K
and across the European market shortly after this.
Professor David Denning of The University of Manchester said of
the announcement: "The approval of micafungin is very good news for
patients with life-threatening fungal infections in Europe. The
Company has conducted a number of large, high quality clinical
studies in Candida infections with impressive results. Particularly
welcome are the indications for fungal infections in children and
babies, often a neglected group in the early drug approval process."
The efficacy and safety of Mycamine(R) have been demonstrated in
a clinical development programme including more than 3,500 patients
in 16 clinical trials. The trials included nearly 300 children.
Mycamine(R) was launched in Japan in 2002 and in the US three years
ago. In these two major markets more than 350,000 patients have been
treated with the product.
"We are delighted that Mycamine(R) is now licensed for use in
Europe," said Alan Houston, MBBS, MRCP, FFPM, Senior Vice President,
Research and Development, Astellas Pharma Europe. "It means that
doctors will now have a new option to treat both their adult and
paediatric - including neonatal - patients with."
Recognising the increasing need for new products to fight the
growing epidemic caused by healthcare associated infections, Astellas
is committed to building a strong anti-infectives franchise. This is
reflected by its extensive clinical trial programme which has been
very positively received by key opinion leaders in the area.
Notes to Editors
Mycamine
The indications for adults, adolescents 16 years of age or older
and  elderly are: Treatment of invasive candidiasis; Treatment of
oesophageal  candidiasis in patients for whom intravenous therapy is
appropriate;  Prophylaxis of Candida infection in patients undergoing
allogeneic  haematopoietic stem cell transplantation or patients who
are expected  to have neutropenia (absolute neutrophil count < 500
cells / microlitre) for 10 or more days. For children (including
neonates) and  adolescents <16 years of age, Mycamine is indicated
for: Treatment of  invasive candidiasis; Prophylaxis of Candida
infection in patients  undergoing allogeneic haematopoietic stem cell
transplantation or patients who are expected to have neutropenia
(absolute neutrophil count <500 cells  / microlitre) for 10 or more
days.
Astellas Pharma Europe Ltd.
Astellas Pharma Europe Ltd., located in the UK, is a European
subsidiary of Tokyo-based Astellas Pharma Inc. Astellas is a
pharmaceutical company dedicated to improving the health of people
around the world through the provision of innovative and reliable
pharmaceutical products. The organisation is committed to becoming a
global category leader by combining outstanding R&D and marketing
capabilities and continuing to grow in the world pharmaceutical
market. In Europe, Astellas markets products in the areas of
Immunology, Urology, Dermatology and Cancer. Astellas Pharma Europe
has 20 affiliate offices located across Europe, the Middle East and
Africa, one R&D site and three manufacturing plants with nearly 3000
staff.
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

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

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