new products to fight the growing EPIDEMIC caused by healthcare associated infec

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22.02.2008 Wirtschaft ots

Juraforum.de - Rühen,Niedersachsen,Germany*

Astellas Receives Positive Opinion From CHMP for Mycamine® for the

Treatment of Serious Fungal Infections

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Staines, England (ots/PRNewswire) -

http://www.juraforum.de/jura/news/news/p/1/id/224013/f/109/

- New Treatment Option Contributes to Fight Against

HealthcareAssociated Infections

Astellas Pharma Europe Ltd(i) announced today that the Committeefor

Medicinal Products for Human Use (CHMP) of the European

MedicinesAgency (EMEA) issued a positive opinion by consensus,

recommending amarketing authorisation for Mycamine®, a treatment

for systemicfungal infections, which are very serious, life-

threateningconditions.

The CHMP's positive recommendation is a critical step in theapproval

process, and Astellas expects to obtain the EuropeanCommission

decision in May.

" This positive opinion from the CHMP for Mycamine® is greatnews

for both doctors and adult and paediatric patients includingneonates

in Europe, " said, Alan Houston MBBS, MRCP, FFPM, Senior

VicePresident, Research & Development, Astellas Pharma Europe. " It

meansthat they will have access to a new, highly effective treatment

forsystemic fungal infections in adult and paediatric patients

includingneonates. This is particularly important as systemic

fungalinfections have a mortality rate of up to 60%(1), " he added.

Mycamine® is a novel treatment for a serious fungal infectionknown

as invasive candidiasis, and its efficacy and safety have

beendemonstrated in an extensive and robust clinical

developmentprogramme including more than 3,500 patients in 16

clinical trials.These trials not only cover large Mycamine®

patient numbers but abroad range of patients including nearly 300

children. Mycamine® isthe market leader in Japan where it was

launched in 2002 (Brand Namein Japan: Funguard®), and in the US,

where Mycamine® was launchedin 2005, the product has already

achieved a 20% market share. Inthese two major markets more than

350,000 patients have been treatedwith the product.

Invasive candidiasis, with reported mortality rates ranging from40%

to 75% of patients, is a frequent cause of morbidity andmortality in

high risk patients.(1) Medical advances in the management of a wide

range of conditions have been accompanied by anincrease in the

number of patients at risk of invasive candidiasis.These include

solid organ or haematopoietic stem celltransplantation, improved

management of patients with burns, cancersand of low weight infants,

and increased numbers of patients with HIVinfection or AIDS.

Astellas seeks to satisfy unmet treatment needsbeyond those afforded

by existing therapies by providing treatmentalternatives for

invasive candidiasis.

Recognising the increasing need for new products to fight the

growing 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.Telavancin, another Astellas product currently under review in

the EUregulatory process, is a novel, bactericidal, once-daily

injectableantibiotic for the treatment of complicated skin and skin

structureinfections caused by Gram-positive bacteria, including

resistantpathogens such as methicillin-resistant Staphylococcus

aureus (MRSA).The product review for telavancin continues under the

EMEA'sCentralised Procedure following its initial submission in

April 2007.

(i)Astellas Pharma Europe Limited, located in the UK, is aEuropean

subsidiary 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 company by combining outstanding R & D and

marketingcapabilities and continuing to grow in the world

pharmaceuticalmarket. Astellas Pharma Europe is responsible for 20

affiliateoffices located across Europe, the Middle East and Africa,

two R & Dsites and three manufacturing plants with approximately 3,300

staff.

Astellas Pharma Europe Limited, Lovett House, Lovett Road,Staines,

Middlesex TW18 3AZ

(1) Gudlaugsson O, et al. Attributable Mortality of

NosocomialCandidemia, Revisited. Clin Infect Dis 2003; 37: 1172-7

Contacts for enquiry or additional information: Astellas Pharma

Europe Jeannine Nolan Communications consultant Mobile: +44(0)

7785508478 Email: jeannine.nolan@... Red Door

Communications Philip R. Sheldon, Director Direct line: +44(0)20-

8392-8093 Mobile: +44(0)792-191-8436 Email: psheldon@... Jas

Kaur, Account Executive Tel: +44(0)20-8392-8040 Email:

jkaur@... Mobile : +44(0)7904-292-908

ots Originaltext: Astellas Pharma Europe LimitedIm Internet

recherchierbar: http://www.presseportal.de

Contact:Contacts for enquiry or additional information: Astellas

Pharma Europe, Jeannine Nolan, Communications consultant, Mobile :

+44(0)7785508478, Email : jeannine.nolan@...; Red Door

Communications, Philip R. Sheldon, Director, Direct line: +44(0)20-

8392-8093, Mobile: +44(0)792-191-8436, Email: psheldon@...;

Jas Kaur, Account Executive, Tel: +44(0)20-8392-8040, Email:

jkaur@..., Mobile : +44(0)7904-292-908