BioAlliance Pharma SA (Euronext Paris – BIO), a Company dedicated to orphan oncology products and specialty products, today announces the receivability of Sitavig® (Sitavir® in Europe) US registration dossier from the Food and Drug Administration(FDA) for the treatment of recurrent orofacial herpes.
According to the US registration procedure, the FDA has 60 days from the date of NDA (New Drug Application) submission to conduct a preliminary review of the registration dossier and to confirm its validity for a substantial review.
This preliminary and required step being achieved, the assessment of Sitavig® registration dossier by the FDA is now entering its effective phase.
“The receivability of Sitavig® registration dossier represents a major achievement for the product’s progress in the United States. It also demonstrates the know-how of our preclinical, clinical and regulatory teams who, and for the second time, successfully bring one of our products to phase III and then to evaluation for registration in Europe and the United States as well”, comments Pierre Attali, in charge of Strategy and Medical affairs.
The registration dossier, submitted to the FDA first quarter 2012, is based on the results of the pivotal phase III clinical trial conducted in 775 patients. In this trial, one single application of Sitavig® 50mg significantly reduced the occurrence of vesicular lesions and crusts, their time to healing and the severity of symptoms. Moreover, a 9-month follow-up showed that Sitavig® had an effect on the long term, delaying the time to occurrence of the following herpes episode. These significant results are particularly interesting for the treatment of orofacial herpes, a pathology affecting nearly 100 million people worldwide of whom more than one third suffers from recurrent herpes (4 episodes and more a year).
“These successful achievements reinforce the potential value of Sitavig® which is becoming a suitable candidate to international partnership agreements, in line with the defined strategy of our portfolio “Specialty products”. These partnership agreements are important to BioAlliance as they generate direct revenues”, declares Judith Greciet, CEO of BioAlliance Pharma.