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European Medicines Agency Issues Positive Opinion on Micafungin

February 22, 2008 -- Astellas Pharma Europe Ltd announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion by consensus, recommending a marketing authorisation for Mycamine(R), a treatment for systemic fungal infections, which are very serious, life-threatening conditions.

The CHMP's positive recommendation is a critical step in the approval process, and Astellas expects to obtain the European Commission decision in May.

"This positive opinion from the CHMP for Mycamine(R) is great news for both doctors and adult and paediatric patients including neonates in Europe," said, Alan Houston MBBS, MRCP, FFPM, Senior Vice President, Research & Development, Astellas Pharma Europe. "It means that they will have access to a new, highly effective treatment for systemic fungal infections in adult and paediatric patients including neonates. This is particularly important as systemic fungal infections have a mortality rate of up to 60%," he added.

Mycamine(R) is a novel treatment for a serious fungal infection known as invasive candidiasis, and its efficacy and safety have been demonstrated in an extensive and robust clinical development programme including more than 3,500 patients in 16 clinical trials. These trials not only cover large Mycamine(R) patient numbers but a broad range of patients including nearly 300 children. Mycamine(R) is the market leader in Japan where it was launched in 2002 (Brand Name in Japan: Funguard(R)), and in the US, where Mycamine(R) was launched in 2005, the product has already achieved a 20% market share. In these two major markets more than 350,000 patients have been treated with the product.

Invasive candidiasis, with reported mortality rates ranging from 40% to 75% of patients, is a frequent cause of morbidity and mortality in high risk patients.(1) Medical advances in the management of a wide range of conditions have been accompanied by an increase in the number of patients at risk of invasive candidiasis. These include solid organ or haematopoietic stem cell transplantation, improved management of patients with burns, cancers and of low weight infants, and increased numbers of patients with HIV infection or AIDS. Astellas seeks to satisfy unmet treatment needs beyond those afforded by existing therapies by providing treatment alternatives for invasive candidiasis.

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. Telavancin, another Astellas product currently under review in the EU regulatory process, is a novel, bactericidal, once-daily injectable antibiotic for the treatment of complicated skin and skin structure infections caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). The product review for telavancin continues under the EMEA's Centralised Procedure following its initial submission in April 2007.

Source: Astellas Pharma Europe

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