Astellas Receives Positive Opinion From CHMP for Mycamine(R) for the Treatment of Serious Fungal Infections
22/02/2008 13:06
PR Newswire
STAINES, England, February 22 /PRNewswire/ --
- New Treatment Option Contributes to Fight Against Healthcare Associated
Infections
Astellas Pharma Europe Ltd(i) 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%(1)," 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.
(i)Astellas Pharma Europe Limited, 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 company by
combining outstanding R? and marketing capabilities and continuing to grow
in the world pharmaceutical market. Astellas Pharma Europe is responsible for
20 affiliate offices located across Europe, the Middle East and Africa, two
R? sites 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 Nosocomial
Candidemia, 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
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