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

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™ 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.

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References

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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.  

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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