Viratek Inc. said Monday that it expects to submit a new drugapplication (NDA) to the FDA by the end of June for Virazole to treatchronic hepatitis C. The announcement was made after review of PhaseIII multicenter data on the anti-viral drug."We feel good about the results," Mark Taylor, head of investorrelations for Viratek and affiliated companies, told BioWorld. "Therewere clinical endpoints established with the FDA, and we can't reallydiscuss the actual results until they've been presented in a peer-reviewed format."The NDA is based on three Phase II and two Phase III clinical studiesof Virazole capsules, two human pharmocokinetic studies and 11 newanimal toxicity studies, in addition to other required data, the companysaid.Virazole already has been approved in more than 40 countries invarious formulations for a number of indications, including generalhepatitis, influenza, HIV, herpes simplex virus, measles, andhemorrhagic fever. It is available in aerosol form in the U.S. and about18 other countries for infants with severe lung infection caused byrespiratory syncytial virus. It is sold in oral, ointment, capsule andaerosol form.The drug was synthesized in 1972 and its has shown to be active invitro against over 50 different RNA and DNA viruses."It is our hope that Virazole provides a superior risk/benefit profile tothe only treatment available (for hepatitis C), which is interferonalpha," Taylor said. "It is our hope that the clinical utility, as measuredby response rate and side effects, in addition to a lower cost/treatmentregimen, provides chronic hepatitis C patients with a compellingtreatment alternative."He said there are an estimated 1.8 million people in the U.S. who havethe hepatitis C virus, as many as 285,000 of whom have the chronicform of the disease. An alarming result of the virus, Taylor said, is thefrequency with which patients develop chronic liver diseases."We believe our drug, at least at this stage, can be extremely helpful incontrolling the progression of the disease," he said.Viratek of Costa Mesa, Calif., is 63 percent owned by ICNPharmaceuticals Inc. Viratek owns the patent for Virazole, while SPIPharmaceuticals Inc. is licensed to market the drug. ICN owns 39percent of SPI. Both SPI and ICN are based in Costa Mesa.
-- Jim Shrine
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