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Under EMEA guidelines, Orphan Medicinal Product Designation provides 10years of potential market exclusivity if the product candidate is approved formarketing in the European Union. Orphan status also permits EMEA assistancein optimizing the candidate's clinical development through participation indesigning the clinical protocol and preparing the marketing application.Additionally, a drug candidate designated by the EMEA as an Orphan MedicinalProduct may qualify for a reduction in regulatory fees as well as a EuropeanUnion-funded research grant. Finally, when a Pediatric Investigation Plan iscompleted, an additional two years of exclusivity could be granted for aproduct with orphan medicinal product designation.
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"We are very pleased to receive orphan designation for CAMVIA from theEMEA," commented Thierry Darcis, M.D., ViroPharma's vice president and generalmanager, Europe. "This designation clearly recognizes the potential toaddress great unmet medical needs with CAMVIA as we work to maximize theglobal value of the drug. This designation from the EMEA adds additionalmomentum as we continue to develop CAMVIA for transplant-relatedcytomegalovirus disease. We commend the European Commission for providingincentives for the development of drugs for rare and life threateningdiseases."
"ViroPharma is in a period of great global progress with CAMVIA," addedMichel de Rosen, ViroPharma's chief executive officer. " We initiated onepivotal Phase 3 study in stem cell transplant patients in late 2006; presentedexcellent and unequivocal Phase 2 data at the 2006 meeting of the AmericanSociety of Hematology; were granted Orphan Drug Designation from the U.S. Foodand Drug Administration this year; and began dosing in our second pivotalphase 3 study in solid organ liver transplant patients in September. We aregenerating strong excitement from US and European transplant physicians andthis European designation marks yet another important positive step as we movediligently toward our goal of regulatory filings in the US and Europe in2009."
About CAMVIA
CAMVIA(TM) (maribavir) is a potent and selective, orally bioavailablePhase 3 antiviral drug with a unique mechanism of action againstcytomegalovirus and a favorable early clinical safety profile. It is a potentmember of a new class of drugs called benzimidazole ribosides. Unlikecurrently available anti-CMV agents that inhibit CMV DNA polymerase, CAMVIAinhibits viral DNA assembly and inhibits egress of viral capsids from thenucleus of infected cells. CAMVIA is active in vitro against strains of CMVthat are resistant to commonly used anti-CMV drugs.
About Cytomegalovirus
CMV is a member of the herpes virus group, which includes the viruses thatcause chicken pox, mononucleosis, herpes labialis (cold sores), and herpesgenitalis (genital herpes). Like other herpesviruses, CMV has the ability toremain dormant in the body for long periods of time. Human CMV infectionrates average between 50 percent and 85 percent of adults in the U.S. by 40years of age, but in healthy adults causes little to no apparent illness.However, in immunocompromised individuals including cancer patients, HIVpatients, and transplant patients, and in children born with primary CMVinfection, CMV can lead to serious disease or death. Patients who areimmunosuppressed
