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New Data Demonstrates DIFICLIR(TM) May Offer Benefits for Cancer Patients, who are at High Risk of Clostridium Difficile Infection

March 30, 2012

STAINES, UK, March 31, 2012 /PRNewswire/ –

Clostridium difficile infection (CDI), a potentially fatal disease, is one

of the most common healthcare acquired infections in Europe[1]

New data presented at the 22nd European Congress of Clinical Microbiology and
Infectious Diseases (ECCMID) demonstrate that in cancer patients with CDI, DIFICLIR(
fidaxomicin) may offer significant benefits in terms of clinical cure*, recurrence[#] and
sustained clinical cure[=].[2]

The data presented were derived from two Phase III clinical trials. A post hoc
analysis compared outcomes in patients who had a diagnosis of cancer with outcomes for
patients who did not. In the clinical trials, the data on cancer diagnosis was not
collected as a pre-defined endpoint.

CDI is the leading cause of healthcare-acquired diarrhoea in adults[1] and has become
an increasing problem in hospitals, nursing homes and other long-term care facilities.[3]
A person’s risk of CDI increases with a longer period of hospitalisation.[4] Patients who
have received chemotherapy and those with solid tumours can be particularly susceptible to
CDI due to their long hospital stays and exposure to many antibiotics and chemotherapeutic
agents.[5]

“Patients with cancer represent a vulnerable population who are at high risk of CDI,
often resulting from their compromised immune system. CDI can be a devastating addition
for patients who are already battling pre-existing conditions. Treatment options that
reduce the burden of CDI and in particular recurrence, will allow clinicians to focus
their efforts on treating the cancer.” said Professor Oliver Cornely, Medical Director of
the Clinical Trial Center of The University of Cologne, Germany and lead investigator of
the study.

In two Phase III clinical trials, there were 1105 patients with CDI in the total
modified-intent-to-treat (mITT) population, of which 183 (16.6%) patients had a current
diagnosis of cancer. A post-hoc analysis of the data from this sub-group of cancer
patients shows that CDI results in a lower clinical cure rate and prolonged episodes of
diarrhoea.[2] When compared to patients treated with vancomycin, those treated with
DIFICLIR had higher clinical cure (97.3% vs. 87.5%) and sustained clinical cure (83.6% vs.
61.3%), as well as reduced rates of recurrence (14.1% vs. 30.0%) in this population.[2]

Further data announced at ECCMID, and published this month in the Lancet Infectious
Diseases supports existing DIFICLIR data by demonstrating that DIFICLIR has a similar
efficacy and tolerability profile to oral vancomycin and also offers the benefit of a
superior sustained response and a greater reduction in rates of recurrence.[6]

Results from the Phase III clinical trial (Study OPT-80-004) of 509 adults across
Europe and North America with a diagnosis of CDI showed that patients treated with
DIFICLIR had a significantly lower rate of CDI recurrence (12.7%) compared with those
receiving vancomycin (26.9%, p<0.001). In addition, DIFICLIR recipients were more likely
than those treated with vancomycin to achieve sustained clinical cure (76.6% vs. 63.4%
respectively, p=0.001).[6]

“Results from key Phase III trials and the post-hoc analysis demonstrate the
effectiveness of DIFICLIR as a novel and effective treatment in patients with CDI, but
also in high risk populations, such as patients with cancer,” said Ken Jones, President
and CEO of Astellas Pharma Europe Ltd. “Astellas are committed to developing effective
treatments for patients where there is a clear unmet medical need.”

DIFICLIR, known as DIFICID(TM) in the US, was discovered and developed by Optimer
Pharmaceuticals, Inc. It was approved by the US Food and Drug Administration in May
2011[7]and received European marketing authorisation in December 2011 for the treatment of
adults with CDI, also known as C. difficile-associated diarrhoea (CDAD).[8] 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.

* Clinical cure: the resolution of diarrhoea for the duration of treatment and no need
for further CDI therapy two days after completion of study medication, as determined by
the investigator.

[#] Recurrence of CDI: a positive result for the presence of a C. difficile toxin in
the stool within 30 days of cessation of therapy.

[=] Sustained clinical cure: the resolution of diarrhoea without recurrence within
four weeks of completing therapy.

NOTES TO EDITORS:

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. Patients typically develop CDI after the use
of broad-spectrum antibiotics that disrupt normal bowel flora, allowing C. difficile
bacteria to flourish.[3] The risk of CDI and disease recurrence is particularly high in
patients aged 65 years and older.[9] Recurrence of CDI occurs in up to 25% of patients
within 30 days of initial treatment with current therapies. [10,11,12] The European
Society of Clinical Microbiology and Infectious Diseases (ESCMID) has identified
recurrence as being the most important problem in the treatment of CDI.[13] CDI also
results in substantial costs to healthcare systems, in particular because of extended
hospitalisation.[14] Patients with CDI stay in hospital for approximately 3.6 days longer
and have 54% higher adjusted hospital costs compared with those without CDI.[15]

About Astellas Pharma Europe

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 4,200 staff across these regions. For more
information about Astellas Pharma Europe, please visit http://www.astellas.eu.

###

References

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

2. Cornely A, et al. Clinical outcomes for cancer patients with Clostridium difficile
infection. 22nd Annual European Congress of Clinical Microbiology and Infectious Diseases
(ECCMID); London, England, 31 Mar – 3 Apr 2012; Abstract P2289.

3. McMaster-Baxter NL, Musher DM. Clostridium difficile: recent epidemiologic findings
and advances in therapy. Pharmacotherapy. 2007;27:1029-39.

4. McFarland V et al. Renewed interest in a difficult disease: Clostridium difficile
infections-epidemiology and current treatment strategies. Curr Opin Gastroenterology.
2009;25(1):24-35.

5. Chopra T, et al. Clostridium difficile Infection in Cancer Patients and
Hematopoietic Stem Cell Transplant Recipients. Expert Rev Anti Infect Ther. 2010; 8 (10):
1113-1119.

6. Cornely A, 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 Diseases. 2012;12(4):281-9.

7. Food and Drug Administration. FDA approves treatment for Clostridium difficile
infection [Internet]. [updated May 27 2011; cited September 16 2011]. Available from

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm257024.htm.

8. European Commission. Community register of medicinal products for human use.
http://ec.europa.eu/health/documents/community-register/html/h733.htm. Last accessed
January 2012.

9. Pepin J, et al. Increasing risk of relapse after treatment of Clostridium difficile
colitis in Quebec, Canada. Clin Infect Dis. 2005;40:1591-7.

10. 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.

11. Lowy I, et al. Treatment with Monoclonal Antibodies against Clostridium difficile
Toxins. N Engl J Med. 2010;362;3:197-205.

12. Louie TJ, et al. Fidaxomicin versus vancomycin for Clostridium difficile
infection. N Engl J Med. 2011;364:422-31.

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. Ghantoji SS, et al. Economic healthcare costs of Clostridium difficile infection:
a systematic review. J Hosp Infect. 2010;74:309-18

15. Kyne L, et al. Health care costs and mortality associated with nosocomial diarrhea
due to Clostridium difficile. Clin Infect Dis. 2002;1;34(3):346-53.

SOURCE Astellas Pharma Europe


Source: PR Newswire