EXTON, Pa., Sept. 26, 2005 (PRIMEZONE) -- ViroPharma Incorporated (Nasdaq:VPHM) today reiterated that the company is engaged in efforts to meet the increased concerns of severe disease caused by an emerging strain of Clostridium difficile. These efforts include the launch of a major educational campaign to raise clinician awareness of the changing landscape of C. difficile-associated disease. ViroPharma commercializes Vancocin(r), which is indicated for the treatment of antibiotic-associated pseudomembranous colitis caused by C. difficile.
New information on an emerging strain of C. difficile was published in the September 24th edition of the Lancet (2005; 366: 1079-84). The paper, entitled "Toxin Production by an Emerging Strain of Clostridium difficile Associated with Outbreaks of Severe Disease in North America and Europe" was authored by Michel Warny et al. This report provided evidence that the strain of C. difficile involved in the ongoing epidemic produces 16 to 23 times more toxin than historical strains of this organism. In addition, it has been associated with a more rapidly progressive disease and significant increase in morbidity and mortality. The authors conclude that this "could represent a major shift in the epidemiology of C. difficile-associated disease." The bacteria have been linked to numerous hospital disease outbreaks and patient deaths in the U.S., Canada and several European countries.
"We take our responsibility very seriously as the company that makes available Vancocin, the only approved product to treat severe C. difficile disease," commented Colin Broom, M.D., ViroPharma's chief scientific officer. "We, along with numerous medical and governmental institutions, are watching the development of this epidemic very carefully. As part of our efforts, we have committed significant resources toward medical education efforts to help clinicians prevent, diagnose, and treat severe C. difficile. Moreover, we are investing in manufacturing, including the qualification of a process that, if we are successful, would increase our capacity in 2006 and beyond."
The company has undertaken a number of initiatives to combat the C. difficile epidemic in patients with severe disease, including efforts to:
-- Launch medical education programs, and initiate a study to develop
a predictive model to identify patients with severe C. difficile
associated disease;
-- Launch the C. difficile surveillance network, to monitor the
epidemiology and treatment practices of C. difficile-associated
disease in the U.S., and;
-- Increase capacity for potential future increased demand as part
of qualifying the company's third party supply chain for Vancocin.
"Recent publications have highlighted the overall increase in incidence and severity of this dangerous disease," continued Dr. Broom. "The most striking element of this epidemic is the significant increase that certain institutions are experiencing in morbidity and mortality associated with this disease. This is perhaps driven by this variant strain's ability to produce substantially more toxin than any strain we've seen in the past. This puts additional emphasis on prompt treatment with an effective therapy for patients with severe disease. Our efforts at ViroPharma are not only focused on aiding physicians through our medical education efforts in their diagnosis of patients who may have severe repercussions from infections, but also on preparing for the possibility of a continued epidemic of C. difficile disease. We are dedicated to helping clinicians identify and treat patients with severe disease."
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. Advanced age, gastrointestinal surgery/manipulation, long length of stay in healthcare settings, a serious underlying illness and immunocompromising conditions are associated with increased risk of disease. According to the U.S. Centers for Disease Control and Prevention (CDC), there are approximately 3,000,000 cases of antibiotic associated diarrhea per year, of which 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(r), 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 http://www.viropharma.com/docs/pulvules_pi.pdf). 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 www.viropharma.com.
Certain statements in this press release may contain forward-looking statements that involve a number of risks and uncertainties, including those relating to continued increase in C. difficile disease incidence and severity, and our efforts to increase manufacturing capacity, launch medical education programs related to C. difficile-associated disease and launch the C. difficile surveillance network. Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. The commercialization of pharmaceutical products is subject to risks and uncertainties. There can be no assurance that there will be no decreases in the rate of infections for which Vancocin is prescribed or changes in the prescribing or procedural practices of infectious disease, gastroenterologists and internal medicine doctors. Moreover, there can also be no assurance that we will be successful in avoiding manufacturing, supply or distribution interruptions, which may result from, among other things, difficulties encountered in qualifying a third party supply chain, and which may result in restrictions on our ability to acquire adequate supplies of Vancocin to meet demand for the product. These factors, and other factors, including, but not limited to those described in ViroPharma's quarterly report on Form 10-K for the year ended December 31, 2004, 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.