EXTON, Pa., Nov. 12 /PRNewswire-FirstCall/ -- ViroPharma Incorporated today announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) has granted orphan drug designation for CAMVIA for the prevention of cytomegalovirus (CMV) disease in patients with impaired cell-mediated immunity. The EMEA’s “Orphan Medicinal Product Designation” is designed to promote the development of drugs which may provide significant benefit to patients suffering from rare diseases identified as “life-threatening or very serious conditions.”
Under EMEA guidelines, Orphan Medicinal Product Designation provides 10 years of potential market exclusivity if the product candidate is approved for marketing in the European Union. Orphan status also permits EMEA assistance in optimizing the candidate’s clinical development through participation in designing the clinical protocol and preparing the marketing application. Additionally, a drug candidate designated by the EMEA as an Orphan Medicinal Product may qualify for a reduction in regulatory fees as well as a European Union-funded research grant. Finally, when a Pediatric Investigation Plan is completed, an additional two years of exclusivity could be granted for a product with orphan medicinal product designation.
“We are very pleased to receive orphan designation for CAMVIA from the EMEA,” commented Thierry Darcis, M.D., ViroPharma’s vice president and general manager, Europe. “This designation clearly recognizes the potential to address great unmet medical needs with CAMVIA as we work to maximize the global value of the drug. This designation from the EMEA adds additional momentum as we continue to develop CAMVIA for transplant-related cytomegalovirus disease. We commend the European Commission for providing incentives for the development of drugs for rare and life threatening diseases.”
“ViroPharma is in a period of great global progress with CAMVIA,” added Michel de Rosen, ViroPharma’s chief executive officer. " We initiated one pivotal Phase 3 study in stem cell transplant patients in late 2006; presented excellent and unequivocal Phase 2 data at the 2006 meeting of the American Society of Hematology; were granted Orphan Drug Designation from the U.S. Food and Drug Administration this year; and began dosing in our second pivotal phase 3 study in solid organ liver transplant patients in September. We are generating strong excitement from US and European transplant physicians and this European designation marks yet another important positive step as we move diligently toward our goal of regulatory filings in the US and Europe in 2009.”
About CAMVIA
CAMVIA(TM) (maribavir) is a potent and selective, orally bioavailable Phase 3 antiviral drug with a unique mechanism of action against cytomegalovirus and a favorable early clinical safety profile. It is a potent member of a new class of drugs called benzimidazole ribosides. Unlike currently available anti-CMV agents that inhibit CMV DNA polymerase, CAMVIA inhibits viral DNA assembly and inhibits egress of viral capsids from the nucleus of infected cells. CAMVIA is active in vitro against strains of CMV that are resistant to commonly used anti-CMV drugs.
About Cytomegalovirus
CMV is a member of the herpes virus group, which includes the viruses that cause chicken pox, mononucleosis, herpes labialis (cold sores), and herpes genitalis (genital herpes). Like other herpesviruses, CMV has the ability to remain dormant in the body for long periods of time. Human CMV infection rates average between 50 percent and 85 percent of adults in the U.S. by 40 years of age, but in healthy adults causes little to no apparent illness. However, in immunocompromised individuals including cancer patients, HIV patients, and transplant patients, and in children born with primary CMV infection, CMV can lead to serious disease or death. Patients who are immunosuppressed following hematopoietic stem cell (bone marrow) or solid organ transplantation are at high risk of CMV infection. In these patients, CMV can lead to severe conditions such as pneumonitis or hepatitis, or to complications such as acute or chronic rejection of a transplanted organ. While currently available systemic anti-CMV agents are effective against the virus, their use is limited by toxicities, most notably bone marrow suppression and renal impairment.
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/Vancocin_pi_2007.htm). 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 those relating to the potential that CAMVIA could provide medical value and address great unmet medical needs, and our ability to maximize the global value of the drug. Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. The development and commercialization of pharmaceutical products is subject to risks and uncertainties. The antiviral and tolerability data that were elucidated in our Phase 2 study designed to assess the rate of CMV reactivation in patients undergoing allogeneic stem cell transplantation may not be predictive of the results of our Phase 3 programs in allogeneic stem cell transplantation or liver transplant patients and further testing such as the ongoing Phase 3 clinical studies may not support any or all of the statements in this press release. There can be no assurance that that our Phase 3 programs will yield positive results, that the FDA or other regulatory authorities will not require additional or unanticipated studies or clinical trial outcomes before granting regulatory approval, or that ViroPharma will be successful in gaining regulatory approval of CAMVIA in the US or other jurisdictions. These factors, and other factors, including, but not limited to those described in ViroPharma’s quarterly report on Form 10-Q for the quarter ended September 30, 2007 and prior periodic reports 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
CONTACT: William C. Roberts, Senior Director, Corporate Communications,
+1-610-321-6288, or Robert A. Doody, Manager, Corporate Communications,
+1-610-321-6290, both of ViroPharma Incorporated
Web site: http://www.viropharma.com/
