Viratek Inc. said Monday that its antiviral agent, Virazole, will bereviewed as a treatment for chronic hepatitis C in the European Union(EU) under the Concertation Procedure as a List B product formarketing in the union.That allows the Costa Mesa, Calif., company a simultaneous review inthe 12-member EU, as well as a 7- to 10-year protection period fromgeneric brands if the drug is approved. The List B designation is forproducts that show promising treatment potential for disease states ofsignificant therapeutic interest, Viratek said.On June 2, Viratek filed a new drug application (NDA) with the FDAfor the same drug and indication. The European submission was basedon the same package of data sent to the FDA, which included resultsfrom three Phase II and three Phase III clinical studies of Virazolecapsules, as well as additional human and animal studies.Formal Submissions Forthcoming"We're looking forward to making the formal submission in Europe inthe very near future," David Calef, Viratek's vice president,communications, told BioWorld. "Our plan is to file in allpharmaceutical markets throughout the world."The company already has achieved much of that goal, but for otherindications. Virazole has been approved in 47 countries in variousformulations for indications including general hepatitis, influenza,HIV, herpes simplex virus, general herpes, measles and hemorrhagicfever. It is available in aerosol form in the U.S. and about 18 othercountries for infants with severe lung infection caused by respiratorysyncytial virus.Calef said 1993 worldwide sales of Virazole were about $30 million."It has multiple modes of action, which is one of the advantages of thisantiviral over some of the others," Calef said of the nucleoside. "Wehaven't seen resistant strains come up because when one does, one ofthe other modes of action seems to be effective."Viratek is 63 percent owned by ICN Pharmaceuticals Inc., which alsoowns 39 percent of SPI Pharmaceuticals Inc. Viratek holds the patenton Virazole, while sister company SPI holds worldwide marketingrights. Viratek gets a 20 percent royalty on sales of the drug, Calef said.ICN and SPI are both located in Costa Mesa. n
-- Jim Shrine
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