BioAlliance Pharma SA, a company dedicated to the orphan products in oncology and specialty products, has signed an exclusive licensing agreement with Abic Marketing Limited (Teva), a subsidiary of Teva Pharmaceutical Industries Limited, for marketing Sitavig (Acyclovir Lauriad) in Israel.
BioAlliance has designed and developed Sitavig for the treatment of herpes recurrent orofacial immunocompetent patients by more than four episodes per year. Sitavig is a mucoadhesive tablet innovative technology-based oral Lauriad which can deliver very high concentrations of the active ingredient directly into the site of herpes infection. The phase III trial (775 patients), which forms the basis of registration dossier, showed marked efficacy and good safety profile.
Financial terms of this license agreement are not made public. The agreement provides for the payment by Teva Pharma BioAlliance a signature fee and milestone payments and royalties on sales in Israel.
“This first license agreement with Teva represents a major milestone for Sitavig, establishing his interest and commercial potential,” said Judith Greciet, director general BioAlliance. “Teva is the key player in the Israeli market, and becomes a key partner for BioAlliance and marketing Sitavig. This is with great enthusiasm that we embark on the construction of a strong and positive partnership.”
BioAlliance Sitavig designed and developed for the treatment of recurrent orofacial herpes in immunocompromised patients. The effectiveness of Sitavig was validated by a clinical pivotal phase III trial in 775 patients which showed a significant reduction in the appearance of vesicular lesions ((p = 0.043), in Time to wound healing ((p = 0.015), in the episode duration (p = 0.0038) and in the symptom severity (p = 0.008). Sitavig also has an effect in the long run by delaying the appearance of recurrent herpes outbreaks (p = 0.04), followed by a set of nine months.
BioAlliance conceives and develops innovative products, especially referred to hospital and medicines for rare diseases and orphan.