BioAlliance Pharma SA (Euronext Paris – BIO), an innovative Company dedicated to the development of orphan oncology products and to supportive care products, announces the approval of Sitavig® (acyclovir LauriadTM) for the treatment of recurrent labial herpes in 8 European countries*.
The decentralized procedure, with Sweden as Reference Member State, ended with a positive opinion for these first 8 countries. Each country will now issue a national marketing authorization in the coming weeks.
Besides, BioAlliance Pharma plans to pursue the submission of the registration dossier in other European countries as soon as the first quarter of 2013. The evaluation by the Agencies should then last 4 to 6 months.
« This approval in an initial wave of European countries is the first registration of Sitavig® which should be followed in the next few months by its registration in the US and in additional European countries”, declares Pierre Attali, COO of BioAlliance Pharma. “This is the second product coming from the BioAlliance’s research to obtain a European registration, which demonstrates the performance and the skills of the Company”.
BioAlliance Pharma has conceived and developed Sitavig® for the treatment of recurrent labial herpes in immunocompetent patients presenting more than 4 episodes a year. Sitavig® is an innovative mucoadhesive buccal tablet delivering very high concentrations of acyclovir at the site of the herpes infection. Sitavig® combines an established efficacy and a good safety profile. Labial herpes is an infection affecting about 100 millions of patients worldwide of whom more than a third suffers from recurrent herpes (4 or more episodes per year).
* Sweden, United Kingdom, Spain, Italy, Denmark, Finland, Norway, Poland