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Astellas Pharma Europe Limited

New Research Reveals That Mycamine(R) is an Effective Treatment in Children, Young Babies and Premature Infants

Staines, England (ots/PRNewswire)

  • Not for distribution in the United Kingdom
  • Research Adds to Already Demonstrated Efficacy in Adult Population
Parents and paediatricians are today welcoming the results of new
research that adds additional support for an effective and well
tolerated treatment for children with invasive candidiasis. The
research, published today in the September edition of The Pediatric
Infectious Disease  Journal(i), demonstrates that Mycamine(R)
(micafungin) delivers high success  rates(*) (i) in the treatment of
premature infants, babies up to four weeks  old and children. The
study also shows significantly less adverse events (i) leading to
treatment discontinuation with Mycamine(R) compared to liposomal
amphotericin B therapy.
The research is the largest comparative assessment of therapies
for treatment of invasive candidiasis and candidemia in paediatric
patients to date and demonstrates that Mycamine(R) is a new treatment
option for paediatric patients with life-threatening Candida
infections. This is particularly important given the increasing
prevalence of invasive candidiasis in premature babies and seriously
ill children, with reported mortality rates in these groups of around
25%, rising to around 37% in more difficult to treat types of
Candida(ii), (iii). Historically, there has been  a lack of
substantive paediatric data about antifungal therapies on which to
base treatment selection (iii).
Dr Antonio Arrieta, Chief of the Division of Infectious Diseases
at the Children's Hospital, California, said: "Systemic fungal
infections are increasing in frequency as a consequence of the
successful treatment of serious diseases such as cancer and
prematurity. These children are often very fragile hosts with
severely compromised immune systems and easy prey for infections with
opportunistic microbes including fungus.
"It is then imperative that we continue to develop newer, safer
therapeutic modalities to address these infections," he continued.
The new research demonstrates that Mycamine(R) had significantly
fewer adverse events leading to treatment discontinuation compared to
liposomal amphotericin B (3.8% versus 16.7%; p = 0.05) which suggests
a safety advantage for Mycamine(R) in this population.
The research is a substudy of a trial in adults(iv) and was
conducted by  an international team of infectious disease experts at
27 sites across  Europe, South and North America, South Africa, India
and Thailand, in 109  paediatric patients. It contributes to the
already substantial Mycamine(R)  clinical development programme
covering 3,500 patients, including 300  children.
Commenting on the results of the study, Dr Arrieta observed:
"Large randomised double blind comparative trials like the one
mentioned above are of critical importance to evaluate the safety and
efficacy of new agents. Our data suggests that micafungin, a new
antifungal agent, is as effective as currently available agents and
it may have better safety."
*Clinical and mycological response at the end of therapy
Notes to Editors
Invasive candidiasis
Invasive candidiasis, with reported mortality rates ranging from
25% to 37% of paediatric patients, is a frequent cause of morbidity
and mortality in high risk patients(ii, iii). Medical advances in the
management of a wide  range of conditions has 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.
Mycamine(R) (micafungin)
The indications for adults, adolescents greater than or equal to
16 years of age and the elderly are: treatment of invasive
candidiasis; treatment of oesophageal candidiasis in patients for
whom intravenous therapy is appropriate; prophylaxis of Candida
infection in patients undergoing allogeneic haematopoietic stem cell
transplantation or patients who are expected to have neutropenia
(absolute neutrophil count < 500 cells/micro  litre) for 10 or more
days. For children (including neonates) and adolescents  <16 years of
age, Mycamine(R)is indicated for: treatment of invasive  candidiasis;
prophylaxis of Candida infection in patients undergoing  allogeneic
haematopoietic stem cell transplantation or patients who are
expected to have neutropenia (absolute neutrophil count < 500
cells/micro  litre) for 10 or more days.
Astellas Pharma Europe Ltd.
Astellas Pharma Europe Ltd., 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 category leader by combining outstanding R&D and marketing
capabilities and continuing to grow in the world pharmaceutical
market. In Europe, Astellas markets products in the areas of
Transplant, Urology, Dermatology, Infectious diseases and Cancer.
Astellas Pharma Europe has 20 affiliate offices located across
Europe, the Middle East and Africa, one R&D site and three
manufacturing plants. Astellas Pharma Europe employs approximately
3,200 staff. For more information about Astellas Pharma Europe,
please visit our website at http://www.astellas-europe.co.uk/.
Astellas Pharma Europe Ltd., Lovett House, Lovett Road, Staines,
Middlesex TW18 3AZ.
i Queiroz-Telles F, Berezin E, Leverger G et al. Micafungin
versus Liposomal Amphotericin B for Pediatric Patients with Invasive
Candidiasis: Substudy of a Randomized Double-blind Trial. The Pediatr
Infect Dis J. 1st August 2008 [publish ahead of print version].
ii Celebi S et al. Nosocomial candidaemia in children: results of
a 9-year study. Mycoses 2008;51:248-257.
iii Almirante B and Rodriguez D. Antifungal agents in neonates.
Pediatr Drugs 2007;9(5):311-321.
iv Kuse ER, Chetchotisakd P, da Cunha CA, et al. Micafungin
versus liposomal amphotericin B for candidaemia and invasive
candidiasis in a phase III, randomised double-blind trial. Lancet
2007;369:1519-1527.

Contact:

For more information please contact: Mindy Dooa, Astellas Pharma
Europe, Tel: +44(0)1784-419-000, Email: Mindy.Dooa@eu.astellas.com.
Rosie Allan, Red Door Communications, Tel: +44(0)20-8392-6931, Email:
rallan@rdcomms.com. Jas Kaur, Red Door Communications, Tel:
+44(0)20-8392-8096, Email: jkaur@rdcomms.com

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