EXTON, Pa., Feb. 27 /PRNewswire-FirstCall/ -- ViroPharma Incorporated today announced that the company has entered into a licensing agreement with Dr. Dale N. Gerding, Associate Chief of Staff for Research at the Hines VA Hospital, for the rights to develop non-toxigenic strains of C. difficile for the treatment and prevention of C. difficile-associated disease (CDAD). ViroPharma plans to initially focus its efforts on the opportunity to prevent recurrence of CDAD following treatment with Vancocin(R). ViroPharma is currently conducting feasibility studies.
"We are very excited to be chosen to enter into this agreement with Dr. Gerding to acquire the rights to this very promising early stage therapeutic opportunity, as it fits perfectly with our strategic focus on this dangerous disease," commented Dr. Colin Broom, ViroPharma's chief scientific officer. "Reducing recurrence of disease is a growing medical need. This novel treatment approach to prevent disease recurrence involves the oral administration of non-toxin producing spores of C. difficile following initial treatment of acute CDAD. The underlying concept is to first treat the disease and eradicate the toxin-producing C. difficile. Subsequently, the GI tract would then be colonized with non-toxin-producing C. difficile which should prevent the 'bad' bugs from re-infecting the colon until normal GI flora returns and the patient is no longer susceptible to disease. The scientific and clinical rationale for this approach is compelling based on animal data and the clinical observation that patients determined to have been naturally colonized with these non-toxigenic strains are protected from developing CDAD."
Dr. Broom continued, "In addition to this exciting, early stage opportunity, we expect to add one or two additional value drivers to the company during 2006."
Patients who are given antibiotic therapy are at risk of colonization with C. difficile and the subsequent development of CDAD, if the bacteria are toxin-producing strains. Asymptomatic colonization by C. difficile has been shown to reduce rates of CDAD. Data from four prospective studies in which rectal swab cultures were obtained weekly from hospitalized patients showed that rates of CDAD in non-colonized patients was 3.6 percent compared to 1.0 percent in patients colonized with C. difficile in the prior week. (P=0.021) (Shim JK, Johnson S, Samore MH, Bliss DZ, Gerding DN. "Primary symptomless colonization by Clostridium difficile and decreased risk of subsequent diarrhoea." Lancet 1998; 351: 633-636.) Preclinical data has demonstrated that colonization with non-toxigenic C. difficile strains can prevent recurrent disease in animals challenged with toxigenic strains. (Sambol SP, Cheknis A, Johnson S, Gerding DN. "Prevention of recurrent Clostridium difficile (CD) disease in hamsters by colonization with non-toxigenic CD following treatment with vancomycin. 45th Annual ICAAC, Washington, DC, Dec. 16-19, 2005. Abstract B-36.)
"I am delighted that ViroPharma has entered into this agreement to bring non-toxigenic C. difficile forward for human use," commented Dr. Gerding. "They have shown their commitment to improving treatment of patients with this increasingly frequent and severe disease. Now, through this licensing agreement, they have again shown great foresight to undertake development of this novel therapeutic approach that may one day change the entire paradigm of CDAD treatment and prevention. My goal as a clinician and researcher has been to not only effectively treat, but also prevent this debilitating and frequently fatal disease. I am enthusiastic about ViroPharma taking our common goal to the next level."
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 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, 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 http://www.viropharma.com.
Certain statements in this press release may contain forward-looking statements that involve a number of risks and uncertainties, including the Company's plans to conduct feasibility studies with non-toxigenic C. difficile. The Company's efforts in non-toxigenic C. difficile are pre- clinical stage programs, and as such are subject to risks and uncertainties. The advancement of promising product candidates through preclinical development and clinical development, and pursuing regulatory approval of product candidates that appear to demonstrate the requisite safety and efficacy, requires considerable time and expense. There can be no assurance that ViroPharma's efforts in non-toxigenic C. difficile will yield positive results, will result in effective treatments in a timely manner, if at all, or that the FDA would approve any non-toxigenic C. difficile product candidates. Also, there can be no assurance that ViroPharma's business development activities and studies with any of its product candidates can be conducted within the timeframe that the company expects, or at all, or that such activities will yield positive results. 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 current report on Form 8-K filed with the Securities and Exchange Commission on November 29, 2005 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.
ViroPharma IncorporatedCONTACT: William C. Roberts, Director, Corporate Communications,ViroPharma Incorporated, +1-610-321-6288
Web site: http://www.viropharma.com/
