BioAlliance Pharma SA (Euronext Paris – BIO), a company dedicated to the supportive care and treatment of cancer patients, today announced submission mid-2011 of its acyclovir Lauriad® European registration dossier, upon advice of the Health Authorities. Acyclovir Lauriad® is BioAlliance Pharma second product using the Lauriad® technology and has been developed for the treatment of recurrent herpes labialis in immunocompetent patients. The dossier will be submitted through a European decentralized procedure and will be based on the final positive results of its pivotal phase III clinical trial.
This international multicenter randomized, double-blind, placebo-controlled study compared the efficacy and safety of a single dose of acyclovir Lauriad® 50mg Mucoadhesive Buccal Tablet (MBT) versus matching placebo in 1727 randomized and 775 treated patients suffering from recurrent herpes labialis. Positive final results demonstrated the success of this trial. Primary and secondary endpoints have been met with marked efficacy and good tolerance. A single dose of acyclovir Lauriad® 50mg MBT significantly reduced the time to healing of primary vesicular lesion (p=0.017). Secondary clinical endpoints showed the duration of episode from the prodromal symptoms to healing to be significantly decreased (p=0.0038) and the percentage of patients with abortive episodes (episode not progressing to vesicular lesion) to be increased (p=0.042). Moreover, the occurrence of vesicular lesions was prevented and the time to recurrence to the next episode of infection was markedly delayed after application of acyclovir Lauriad® (p=0.05).
“Acyclovir Lauriad® has demonstrated its capacity to control a recurrent and very painful infection hampering the quality of life of a large number of patients with one single dose application of 50mg. Acyclovir Lauriad® represents an innovation addressing a large potential prescription market for which we are looking for the appropriate partner”, declares Dominique Costantini, CEO of BioAlliance Pharma. “After Loramyc® and Setofilm®, acyclovir Lauriad® will contribute to our recurring revenues, in line with our business model”.