A major step forward in the development of Sitavir®: European registration file submission for the treatment of recurrent orofacial herpes

BioAlliance Pharma SA (Euronext Paris – BIO), a company dedicated to specialty and orphan oncology products, today announced submission of its Sitavir® (acyclovir Lauriad™) European registration dossier through a European decentralized procedure*.
BioAlliance Pharma has conceived and developed Sitavir® for the treatment of recurrent orofacial herpes in immunocompetent patients presenting more than 4 episodes a year. Sitavir® is an innovative mucoadhesive buccal tablet delivering very high concentrations of the active ingredient in mucosa and lips, sites of the herpes infection. Sitavir® combines an established efficacy and a good tolerance profile.
« The submission of Sitavir® registration dossier represents a highly significant step for the Company, who once more demonstrates its dynamism in the development of innovative drugs thanks to its teams’ know-how and expertise”, comments Judith Greciet, CEO of BioAlliance Pharma. “Sitavir®’s unique efficacy profile and tolerance are strong competitive assets in a disease where the medical need remains insufficiently met. With an overall sales potential estimated between €150 and €200 millions, Sitavir® is becoming a valuable asset to future strategic partnerships”.
The European registration dossier is based on the results of the pivotal phase III clinical trial conducted in 775 patients, as will also be the US registration dossier that should be submitted to the Food and Drug Administration (FDA) in the coming months. In this trial, one single application of Sitavir® 50mg significantly reduced the occurrence of vesicular lesions (p=0.043), the duration of the herpes episode (p=0.0038) and the severity of symptoms (p=0.008). Moreover, a 9-month follow-up showed that Sitavir® had an effect on the long term, delaying the time to occurrence of the following herpes episode (p=0.04). These remarkable results, both on the episode itself and its possible long term recurrence, represent a major progress in the treatment of orofacial herpes as well as a beneficial socioeconomic value.
Orofacial herpes affects nearly 100 million people worldwide each year. According to a survey performed by the Nielsen Company in 2000 patients, more than one third of them suffered from recurrent herpes (4 episodes and more a year) with an annual average of 6.3 episodes. The disease had a very substantial impact on these patients with 35% among those who were looking for medical advice were already on sick leave due to the herpes inconvenience (pain, physical disability, tiredness,…). In addition, the number of recurrences impacted patients’ quality of life, leading 21% of them to get maintenance therapy to reduce recurrences.
* Austria, Denmark, Finland, France, Germany, Italy, Norway, Poland, Spain, Sweden, United-Kingdom (Sweden as Reference Member State).
About The Nielsen Company
The survey was performed by the Nielsen Company for BioAlliance Pharma, in 2000 French and American patients, with an appropriate methodology and a validated questionnaire
The Nielsen Company is a global information and measurement company with leading market positions in marketing and consumer information, television and other media measurement, online intelligence, mobile measurement, trade shows and related assets. The company has a presence in approximately 100 countries, with headquarters in New York, USA. For more information on The Nielsen Company, visit www.nielsen.com

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