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

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 disease."

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.

NOTES FOR 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.^[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]

About DIFICLIR

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 visit http://www.astellas.eu.

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