Data on Telavancin and Micafungin Hold Promise of New Therapeutic Options in Fight Against Serious Infectious Disease

MUNICH, Germany, April 2 /PRNewswire/ --

- Studies Reinforce Astellas Commitment to Overcoming Critical Shortage of New Antimicrobial Agents

Study results presented at the 17th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) show that the antibiotic telavancin, and the antifungal micafungin, both have the potential to meet a significant unmet need in the fight against serious hospital-acquired infections (HAIs).

Hospital-acquired, or nosocomial infections, are one of the leading causes of death and increased morbidity amongst patients in a hospital setting.(1) Estimates suggest that HAIs cost the UK economy GBP1 billion a year.(2) The greatest contributor to this cost is the increased length of hospital stay for patients with infection.(3),(4),(5)

Telavancin data

Data presented from ATLAS 1 and ATLAS 2, two multinational phase 3 studies, show that telavancin was found to be effective for the treatment of patients with complicated skin and skin structure infections (cSSSIs), including those caused by Gram-positive organisms, including methicillin-resistant Staphylococcus aureus (MRSA).(6),(7)

The results of the two double blind parallel studies, in which 1,867 patients were treated, showed that telavancin compared favorably to standard therapy in clinical cure, microbiological eradication, and overall therapeutic response rates. The safety profile of telavancin in these studies was compatible with treatment of patients with serious infections due to resistant bacteria.

Commenting on the study results, investigator Professor M Stryjewski, Duke Clinical Research Institute, Durham, North Carolina, USA said, "Antibiotic resistant bacterial infections are an emerging issue in hospitals and there is a real risk that we are fast running out of effective treatment options. The results of ATLAS 1 and ATLAS 2 demonstrate that telavancin may offer a new option in our fight against serious bacterial infections".

Telavancin is currently undergoing regulatory review at the U.S. Food and Drug Administration (FDA). Telavancin is a novel, rapidly bactericidal lipoglycopeptide with activity against important Gram-positive bacteria. Telavancin possesses a unique, multivalent, multifunctional mode of action that inhibits bacterial cell wall synthesis and disrupts the functional integrity of the bacterial cell membrane.

Micafungin data

Micafungin data presented show that micafungin demonstrates broad-spectrum efficacy against Candida infections.(8) More specifically data showed that in adult patients with deep, invasive Candida, micafungin was associated with efficacy comparable to established treatments, liposomal amphotericin B (L-AmB) and intravenous caspofungin,(9) and that there were significant safety advantages of micafungin over L-AmB in terms of a difference in acute infusion related reactions and Estimated Glomerular Filtration Rate (eGFR).(10) Data presented also showed that in paediatric patients with invasive candidiasis or candidaemia, micafungin was as effective as standard therapy with AmBisome(R) (L-AmB), with fewer patients experiencing treatment-related adverse events and fewer discontinuations.(11)

Micafungin is currently undergoing clinical evaluation at the EMEA. Micafungin is licensed in the US for the treatment of oesophageal candidiasis and for the prophylaxis of fungal infections caused by Candida in patients who are undergoing a haematopoietic stem cell transplant.

Commenting on the data presented at ECCMID, Dr John Bolodeoku, European Senior Medical Director, Astellas Pharma Inc. said, "Effective prevention and treatment strategies for serious hospital acquired infections represent a significant challenge in healthcare. Astellas look forward to supporting healthcare professionals in their fight against these often fatal infections".

Notes for Editors:

Micafungin and telavancin registration

Micafungin is currently undergoing clinical evaluation with the EMEA. It is anticipated that registration dossiers for telavancin will be submitted to the registration authorities in Q2 2007.

About Astellas

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.

Astellas co-operation

In November 2005, Astellas entered into a collaboration arrangement with Theravance for the development and commercialisation of telavancin worldwide except Japan. In July 2006, Astellas and Theravance expanded the collaboration to include Japan. Under the terms of the collaboration, Theravance will lead the development of telavancin for the treatment of cSSSI and hospital-acquired pneumonia, and will collaborate substantially with Astellas in marketing in the United States for the first three years. Astellas will lead all other development, regulatory, manufacturing, sales and marketing activities.

About Theravance

Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates. Theravance is focused on the discovery, development and commercialisation of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections and gastrointestinal motility dysfunction. Of the five programs in development, two are in late stage - the telavancin program focusing on treating serious Gram-positive bacterial infections with Astellas Pharma Inc. and the Beyond Advair collaboration with GlaxoSmithKline. By leveraging its proprietary insight of multivalency to drug discovery focused on validated targets, Theravance is pursuing a next generation drug discovery strategy designed to discover superior medicines in large markets. For more information, please visit the Company's web site at www.theravance.com.

(1) Ducel G et al. Prevention of Hospital-Acquired Infections. World Health Organization 2002.

(2) Global Patient Safety Challenge 2005 - 2006 http://www.who.int/patientsafety/events/05/GPSC_Launch_ENGLISH_FINAL.pdf

(3) Pittet D, Taraara D, Wenzel RP. Nosocomial bloodstream infections in critically ill patients. Excess length of stay, extra costs, and attributable mortality.JAMA,1994,271:1598-1601.

(4) Kirkland KB et al. The impact of surgical-site infections in the 1990's: attributable mortality, excess length of hospitalization and extra costs. Infect Contr Hosp Epidemiol,1999,20:725-730.

(5) Wakefield DS et al. Cost of nosocomial infection: relative contributions of laboratory, antibiotic, and per diem cost in serious Staphylococcus aureus infections. Amer J Infect Control,1988,16:185-192.

(6) Corey GR et al. ATLAS 1: The first Phase 3 study evaluating the new lipoglycopeptide, telavancin, for the treatment of patients with complicated skin and skin structure infections (cSSSIs). ECCMID, Munich. Abstract number (tbd).

(7) Corey GR et al. ATLAS 2: a double-blind, randomised, active controlled, multinational Phase 3 study comparing telavancin with vancomycin for the treatment of patients with complicated skin and skin structure infections (cSSSIs). ECCMID, Munich. Abstract number (tbd).

(8) Cornely AJ et al. An analysis of the efficacy of micafungin in Candida infections caused by non-albicans Candida species in phase III trials. ECCMID, Munich. Abstract number (tbd).

(9) Ullmann AJ et al. Efficacy of micafungin in patients with deep, invasive Candida infections. ECCMID, Munich. Abstract number (tbd).

(10) Ullmann AJ et al. A review of the safety of micafungin compared with liposomal amphotericin B in a large, phase III trial in patients with invasive candidiasis and candidaemia. ECCMID, Munich. Abstract number (tbd).

(11) Arrieta A et al. Micafungin versus liposomal amphotericin B (AmBisome(R)) in paediatric patients with invasive candidiasis or candidaemia. ECCMID, Munich. Abstract number (tbd).

Contact: Tanya Jishi, Astellas Pharma Ltd, +44(0)207-7632-1832