Mycamine(R) Now Available In 13 EU Markets For Treatment Of Serious Fungal Infections

Main Category: Infectious Diseases / Bacteria / Viruses
Article Date: 21 May 2009 - 0:00 PDT

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MYCAMINE (micafungin), the newest echinocandin, is now available in thirteen European markets: UK, Greece, Czech Republic, Slovakia, Nordic region*, Spain, Germany, Ireland and France following its EU approval in April 2008.

MYCAMINE is a novel treatment for patients suffering from the serious fungal infection known as invasive candidiasis. Invasive candidiasis and other Systemic Candida Infections (including candidemia) are accompanied by high mortality rates, killing almost 40% of those who are infected . The efficacy and safety of MYCAMINE has been demonstrated for a broad range of patient types in an extensive and robust clinical development programme of over 3,000 patients, including 296 children and premature babies.

The latest data on the use of MYCAMINE for the treatment of invasive candidiasis is being presented at a satellite symposium and poster presentation as part of this year's European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) being held in Helsinki, 16-19 May.

Recent medical advances have greatly improved the clinical outcomes of major surgery, organ transplants and cancer. However, this has been accompanied by an increased prevalence and risk of invasive fungal infections due to the immunosuppressive nature of treatment . Treatment resistance and toxicity are two of the main challenges in getting this situation under control , . MYCAMINE has demonstrated potent activity against even the more resistant types of Candida, so-called 'non-albicans', which are more difficult to treat and increasing in prevalence , .

Six more MYCAMINE launches are anticipated within the next year in Portugal, Italy, Belgium, Austria, Poland and Hungary.

MYCAMINE has been available in Japan since 2002 (Brand Name in Japan: FUNGUARD ®) and in the US since 2005, and it has now been used to treat more than 450,000 patients worldwide .

* = Finland, Iceland, Denmark, Sweden and Norway

MYCAMINE® (micafungin)

MYCAMINE is approved for use in adults and children (including infants <12 months of age and premature neonates) for the treatment of invasive candidiasis (including candidaemia) and for prophylaxis of Candida infections in patients undergoing allogenic haematopoietic stem cell transplantation (HSCT) or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/μl) for > 10 days. Following an extensive clinical programme the European authorisation was granted on April 25th 2008. MYCAMINE is also approved in adults (including adolescents > 16 years of age and the elderly) for the treatment of oesophageal candidiasis in patients for whom intravenous (IV) therapy is appropriate.

For full prescribing information please see SmPC (September 2008) attached.

Astellas Pharma Europe Ltd.

Astellas Pharma Europe employs approximately 3,400 people and operates across Europe as well as the Middle East and Africa. Headquartered in London, the company has sales and marketing affiliates in 20 countries, three production facilities and one research and development site.

As a young and forward thinking company with a rich heritage, Astellas is dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.

Astellas Pharma Europe is part of Astellas Pharma Inc. which was formed in April 2005 as a result of the merger of Fujisawa and Yamanouchi, making it one of the largest pharmaceutical companies in Japan and a top 20 pharmaceutical company in the world. Today, Astellas Pharma Inc. employs 14,200 people across the globe .

Astellas Pharma Europe Ltd., Lovett House, Lovett Road, Staines, Middlesex TW18 3AZ

References

1. Tortorano AM, Peman J, Bernhardt H, et al. Epidemiology of candidaemia in Europe: results of 28-month European Confederation of Medical Mycology (ECMM) hospital-based surveillance study. Eur J Clin Microbiol Infect Dis 2004; 23:317-322.
2. MYCAMINE Summary of Product Characteristics. September 2008.
3. Astellas data on file. February 2009.
4. Richardson MD. Changing patterns and trends in systemic fungal infections. J Antimicrob Chemother 2005; 56:i5-i11.
5. Dupont B. Overview of the lipid formulations of amphotericin B. J Antimicrob Chemother 2002; 49 Suppl 1:31-36.
6. Messer SA, Jones RN, Fritsche TR. International surveillance of Candida spp. and Aspergillus spp.: report from the SENTRY Antimicrobial Surveillance Program (2003). J Clin Microbiol 2006; 44:1782-1787.
7. Bassetti M, Righi E, Costa A, et al. Epidemiological trends in nosocomial candidemia in intensive care. BMC Infect Dis 2006; 6:21.
8. Schelenz S, Gransden WR. Candidaemia in a London teaching hospital: analysis of 128 cases over a 7-year period. Mycoses 2003; 46:390-396.
9. IMS MAT August 2008
10. Astellas Pharma Europe 2007 brochure, CB 0607, p3
11. Astellas Pharma Europe 2007 brochure, CB 0607, p1

Source
Pharma Europe Ltd

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