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news.BioAlliance Pharma has submitted its Sitavir (acyclovir Lauriad) European registration dossier through a European decentralized procedure.
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Sitavir is a mucoadhesive buccal tablet used to treat recurrent orofacial herpes in immunocompetent patients presenting more than 4 episodes a year.
The drug delivers high concentrations of the active ingredient in the sites of the herpes infection like mucosa and lips.
The European registration dossier is based on the results of the pivotal phase III clinical trial conducted in 775 patients.
BioAlliance CEO Judith Greciet said the submission of Sitavir registration dossier represents a highly significant step for the company.
"With an overall sales potential estimated between €150 and €200 millions, Sitavir® is becoming a valuable asset to future strategic partnerships," Greciet added.