Astellas Receives Positive Opinion From CHMP for Mycamine(R) for the Treatment of Serious Fungal Infections

Staines, England (ots/PRNewswire) -

- 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(R), 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(R) 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(R) 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(R) patient numbers but abroad range of patients including nearly 300 children. Mycamine(R) isthe market leader in Japan where it was launched in 2002 (Brand Namein Japan: Funguard(R)), and in the US, where Mycamine(R) 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 themanagement 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 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.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@eu.astellas.com Red Door Communications Philip R. Sheldon, Director Direct line: +44(0)20-8392-8093 Mobile: +44(0)792-191-8436 Email: psheldon@rdcomms.com Jas Kaur, Account Executive Tel: +44(0)20-8392-8040 Email: jkaur@rdcomms.com 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@eu.astellas.com; Red Door Communications, Philip R. Sheldon, Director, Direct line: +44(0)20-8392-8093, Mobile: +44(0)792-191-8436, Email: psheldon@rdcomms.com; Jas Kaur, Account Executive, Tel: +44(0)20-8392-8040, Email: jkaur@rdcomms.com, Mobile : +44(0)7904-292-908

Astellas Pharma Europe Limited

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Astellas Receives Positive Opinion From CHMP for Mycamine(R) for the Treatment of Serious Fungal Infections