Healthcare Industry News:  ViroPharma 


 News Release - September 28, 2006

United States Seeing Greater Increases in Clostridium Difficile-Associated Disease Case-Load and Severity

CDAD Global Surveillance to Guide Prevention and Control Measures

EXTON, Pa., Sept. 28 (HSMN NewsFeed) -- New data suggest that the number of cases and severity of Clostridium difficile-associated disease (CDAD) are continuing to increase around the world, particularly in the United States, according to a study sponsored by ViroPharma (Nasdaq: VPHM ) that was presented today at the 2006 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). Through collaboration with several national societies, this web-based CDAD surveillance effort has collected data from clinicians from around the world about their experiences with CDAD patients. C. difficile is the leading infectious cause of antibiotic-associated diarrhea in hospitals. The disease can range from mild/moderate symptoms to severe inflammation of the colon that may require surgery or result in death.

"CDAD is not a reportable disease in most parts of the world; as a result, our understanding of the frequency and severity of cases is limited," said presenting author Steven P. Gelone, Pharm.D., ViroPharma's director of medical affairs. "Gathering data on CDAD based on clinicians' perceptions is an important step in tracking this re-emerging disease. From the data submitted, it appears that the case load and severity of cases of CDAD continues to increase, while treatment relapses are more commonly being encountered, particularly in the U.S. Continued surveillance and education is critical in further elaborating the epidemiology of CDAD and optimizing patient outcomes."

"CDAD rates have been increasing annually in the United States, as have the reports of increased morbidity and mortality associated with the disease; these increases are well documented in published literature and are consistent with my own institutional experience," added Neil Fishman, M.D., study co- author from the University of Pennsylvania. "This international surveillance project is a critical first step in helping clinicians better understand the epidemiology of CDAD and the impact of early diagnosis and aggressive treatment in patients with complicated CDAD. Data have been shared with the Centers for Disease Control and Prevention to assist in public health policy development to fight CDAD. In addition, clinicians who submitted data will receive information from similar institutions so they can compare and improve their treatment practices."

Public health authorities are not required to report C. difficile in most parts of the world, and there is limited understanding of its epidemiology. Through collaboration with a variety of national and international scientific societies, data was collected from more than 1,100 clinicians from various parts of the world. The large number of submissions from various geographic locales enabled the researchers to compare various regions to determine if certain areas have been more significantly affected than others.

Primary Findings

-- Detection techniques differ throughout the World. 60 percent of U.S. respondents reported enzyme immunoassay (EIA) for C. difficile toxins A and B as the most commonly used diagnostic method to detect CDAD compared with 42 percent of non-U.S. respondents

-- Severe CDAD is ill-defined. A lack of uniformity of markers used to classify patients as having severe CDAD exists in both the U.S. and the rest of the world.

-- CDAD is increasing in incidence and with more serious patient outcomes throughout the World. Based on clinicians' perspectives, U.S. centers are experiencing larger increases in patient case-load, patients with severe CDAD, treatment relapses and attributable colectomies than in other parts of the world.

-- 50 percent of U.S. respondents reported increased number cases of CDAD in the last year compared with 31 percent of non-U.S. respondents

-- 51 percent of U.S. respondents reported an increase in the severity of CDAD cases compared with 33 percent of non-U.S. respondents

-- 55 percent of U.S. respondents reported an increase in treatment relapses compared with 37 percent of non-U.S. respondents

-- 32 percent of U.S. respondent reported increases in CDAD- attributable colectomies compared with 19 percent of non-U.S. respondents

-- CDAD mortality rates are increasing throughout the world. An equal proportion of U.S. and non-U.S. clinicians report an increase in the number of CDAD-attributable deaths.

-- Continued CDAD surveillance and education is essential. Identifying the areas most affected by CDAD is critical information that clinicians need to most effectively improve prevention, control and treatment practices.

About Clostridium difficile

C. difficile is a bacterium, which under certain circumstances, typically after antibiotic therapy, can colonize the lower gastrointestinal tract where it may produce toxins which cause inflammation of the colon and diarrhea, and the associated complications of disease, including death. Advanced age, gastrointestinal surgery/manipulation, long length of stay in healthcare settings, a serious underlying illness and compromised immunity are conditions associated with increased risk of disease. According to the CDC, there are approximately 3,000,000 cases of antibiotic-associated diarrhea per year; 15 to 25 percent are caused by C. difficile.

About ViroPharma Incorporated

ViroPharma Incorporated is a biopharmaceutical company dedicated to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin®, approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin- resistant strains (for prescribing information, please download the package insert at ViroPharma currently focuses its drug development activities in viral diseases including cytomegalovirus (CMV) and hepatitis C (HCV). For more information on ViroPharma, visit the company's website at

Certain statements in this press release may contain forward-looking statements that involve a number of risks and uncertainties. Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. These factors, and other factors, including, but not limited to those described in ViroPharma's annual report on Form 10-Q for the quarter ended June 30, 2006 filed with the Securities and Exchange Commission could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in this press release may become outdated over time. ViroPharma does not assume any responsibility for updating any forward-looking statements.

Source: ViroPharma

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