German Federal Joint Committee Recognises "Proof of a Considerable Additional Benefit" For DIFICLIR™ for the Treatment of

German Federal Joint Committee Recognises "Proof of a Considerable Additional
 Benefit" For DIFICLIR™ for the Treatment of Clostridium difficile Infection

  PR Newswire

  CHERTSEY, England, July 22, 2013

CHERTSEY, England, July 22, 2013 /PRNewswire/ --

Clostridium difficile infection (CDI), a potentially fatal disease, is one of
             the most common healthcare acquired infections ^[1]

Astellas Pharma Europe Ltd. announced today that the Federal Joint Committee
(G-BA) of Germany has recognised a "proof of a considerable additional
benefit" for DIFICLIR (fidaxomicin) in patients with severe and/or recurrent
Clostridium difficile infection (CDI) in comparison to therapy with
vancomycin, the current standard of care for these types of CDI.

CDI is one of the most common causes of healthcare-associated diarrhoea. ^[ ^1
^] Hospital patients with CDI are up to three times more likely to die in
hospital (or within a month of infection) than those without CDI. ^[2] ^, ^[3]
Severe cases can lead to bowel surgery and even death. ^[ ^1 ^] CDI has an
enormous impact on healthcare systems and infected patients can stay in
hospital an extra 1-3 weeks ^[4] ^, ^[5] ^, ^[6] ^, ^[7] at an additional cost
of up to €14,000, compared with patients without CDI. ^[8]

"We welcome the G-BA's recognition of DIFICLIR as a significant step towards
improving the standard of care for patients with CDI," said Ken Jones,
President and CEO of Astellas Pharma Europe Ltd. "Until DIFICLIR, the
treatment for CDI had remained largely unchanged for 20 years. With DIFICLIR
we have a real treatment advance that can improve patient outcomes and reduce
the significant burden of this disease."

DIFICLIR received European marketing authorisation in December 2011 ^[9] and
was launched in Germany in January 2013. ^[10] The EU approval was based on
two Phase III clinical studies comparing the efficacy and safety of 400mg/day
oral DIFICLIR with 500mg/day oral vancomycin for a treatment period of 10 days
in adults with CDI. ^[11] ^, ^[12] The proportion of subjects in whom clinical
cure was achieved was similar for the two treatments, hence DIFICLIR met its
primary endpoint of non-inferiority to vancomycin. ^[ ^11 ^] ^, ^[ ^12 ^] In
addition, DIFICLIR was shown to significantly reduce the rate of CDI
recurrence as compared with vancomycin, which means that patients treated with
DIFICLIR were significantly more likely than those receiving vancomycin to
experience diarrhoea resolution without recurrence within 30 days of therapy
completion. ^[11],[12]

Recurrence has been identified by the European Society of Clinical
Microbiology and Infectious Diseases (ESCMID) as being the most important
problem in the treatment of CDI. ^[13] Recurrence of CDI occurs in up to 25%
of patients within 30 days of initial treatment with vancomycin or
metronidazole. ^[ ^11 ^] ^, ^[14] ^, ^[15]

"Patients with serious underlying conditions such as chronic kidney disease,
cancer, or who are immunocompromised are at increased risk of serious
complications associated with CDI," comments Professor Cornely, University of
Cologne, Germany. "With DIFICLIR we have a treatment that can reduce the risk
of further episodes in these patients providing a key step towards improving
the management of CDI and also to reducing the morbidity associated with the

The Gemeinsame Bundesausschuss (G-BA) is the highest decision-making body of
the joint self-government of physicians, dentists, hospitals and health
insurance funds in Germany. The G-BA assesses any additional benefit claimed
by newly authorised pharmaceuticals over the appropriate comparator within six
months of the product launch. Since 2011, G-BA findings have formed the basis
for price negotiations between statutory health insurance providers and the
pharmaceutical industry for new active ingredients.


About  Clostridium difficile   Infection (CDI)

CDI is a serious illness resulting from infection of the internal lining of
the colon by C. difficile bacteria. The bacteria produce toxins that cause
inflammation of the colon, diarrhoea and, in some cases, death. ^[16] Patients
typically develop CDI after the use of broad-spectrum antibiotics that disrupt
normal bowel flora, allowing C. difficile bacteria to flourish. ^[ ^16 ^] ,
^[17] The risk of CDI and disease recurrence is particularly high in patients
aged 65 years and older. ^[18]


DIFICLIR, known as DIFICID™ in the US, was discovered and developed by Optimer
Pharmaceuticals, Inc. It was approved by the US Food and Drug Administration
in May 2011 ^[19] and received European marketing authorisation in December ^[
^9 ^] for the treatment of adults with CDI, also known as C. difficile
-associated diarrhoea (CDAD). ^[ ^9 ^] Astellas Pharma Europe Ltd. is the
exclusive licensee for the development and commercialisation of DIFICLIR in
Europe and additional countries in the Middle East, Africa and the
Commonwealth of Independent States.

About Astellas Pharma Europe Ltd.

Astellas Pharma Europe Ltd., located in the UK, is the European headquarters
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 pharmaceuticals. The organisation is
committed to becoming a global company by combining outstanding R&D and
marketing capabilities and continuing to grow in the world pharmaceutical
market. Astellas Pharma Europe Ltd. is responsible for 21 affiliate offices
located across Europe, the Middle East and Africa, an R&D site and three
manufacturing plants. The company employs approximately 4,300 staff across
these regions. For more information about Astellas Pharma Europe Ltd., please


1.   Ananthakrishnan AN. Clostridium difficile infection: epidemiology, risk
factors and management. Nat Rev Gastroenterol Hepatol . 2011;8:17-26.

2.   Oake N, et al . The effect of hospital-acquired Clostridium difficile
infection on in-hospital mortality. Arch Intern Med . 2010;170:1804-10.

3.   Hensgens MP, et al . All-Cause and disease-specific mortality in
hospitalized patients with Clostridium difficile infection: a Multicenter
Cohort Study. Clin Infect Dis . 2013;56:1108-16.

4.   Vonberg RP, et al . Costs of nosocomial Clostridium difficile
-associated diarrhoea. J Hosp Infect . 2008;70:15-20.

5.   Wilcox MH, et al . Financial burden of hospital-acquired Clostridium
difficile infection. J Hosp Infect . 1996;34:23-30.

6.   Dubberke MD, Wertheimer AI. Review of current literature on the
economic burden of Clostridium difficile infection. Infect Control Hosp
Epidemiol . 2009;30:57-66.

7.   Eckmann C, et al . Increased hospital length of stay attributable to
Clostridium difficile infection in patients with four co-morbidities: an
analysis of hospital episode statistics in four European countries. Eur J
Health Econ . 2013 Jun 25 [Epub ahead of print] 

8.   Magalini S, et al . An economic evaluation of Clostridium difficile
infection management in an Italian hospital environment. Eur Rev Med Pharmacol
Sci . 2012;16:2136-41.

9.   European Commission. Community register of medicinal products for human
use. Last
accessed July 2013.

10.   Gemeinsamer Bundesausschuss. Nutzenbewertungsverfahren zum Wirkstoff
Fidaxomicin, available at: [ ]. Accessed July 2013.

11.   Louie TJ, et al . Fidaxomicin versus vancomycin for Clostridium
difficile infection. N Engl J Med .


12.   Cornely OA, et al . Fidaxomicin versus vancomycin for infection with
Clostridium difficile in Europe, Canada, and the USA: a double-blind,
non-inferiority, randomised controlled trial. Lancet Infect Dis .

13.   Bauer MP, et al . European Society of Clinical Microbiology and
Infectious Disease (ESCMID): treatment guidance document for Clostridium
difficile -infection (CDI). Clin Microbiol Infect . 2009;15:1067-79.

14.   Bouza E, et al . Results of a phase III trial comparing tolevamer,
vancomycin and metronidazole in patients with Clostridium difficile
-associated diarrhoea. Clin Micro Infect . 2008;14(Suppl 7):S103-4.

15.   Lowy I, et al . Treatment with Monoclonal Antibodies against
Clostridium difficile Toxins. N Engl JMed . 2010;362:197-205.

16.   Poutanen, SM et al . Clostridium difficile -associated diarrhoea in
adults. CMAJ . 2004;171:51-8.

17.   Kelly CP, et al . Clostridium difficile infection. Ann Rev Med .

18.   Pepin J, et al . Increasing risk of relapse after treatment of
Clostridium difficile colitis in Quebec, Canada. Clin Infect Dis .

19.   Food and Drug Administration. FDA approves treatment for Clostridium
difficile infection [Internet]. [updated May 27 2011] Available from . Last
accessed July 2013.

Contact: For further information please contact: Donna Wright, Ruder Finn,, Tel: +44(0)207-438-3085; Mindy Dooa, Astellas Pharma
Europe Ltd,, Tel: +44(0)7826-912-339
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