BioAlliance Pharma SA (Euronext Paris – BIO), a company dedicated
to oncology orphan products and specialty products today announces the signature of an
exclusive license agreement for Sitavig® (Acyclovir Lauriad™) with Abic Marketing Limited
(“Teva”), a group subsidiary of Teva Pharmaceutical Industries Limited (NASDAQ: TEVA) for
commercialization rights in Israel.
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 based on the innovative mucoadhesive buccal technology Lauriad™, delivering very high
concentrations of acyclovir at the site of herpes infection. The phase III trial (775 patients)
has shown a strong efficacy and safety profile, basis for the registration submission.
Financial terms of this license agreement are not publicly disclosed. This agreement includes
upfront and milestone payments as well as royalties on sales in Israel, to be paid to
BioAlliance Pharma by Teva.
« This license agreement with Teva is a major step for Sitavig® as it acknowledges the
interest and the commercial potential of this innovative product”, declared Judith Greciet,
CEO of BioAlliance Pharma. “Teva as the leading player on Israeli market is a key partner for
BioAlliance and for the commercialization of Sitavig®, and we look forward to build a
constructive and close partnership”, added Judith Greciet.
BioAlliance Pharma has conceived and developed Sitavig® for the treatment of recurrent orofacial
herpes in immunocompetent patients. The product is an innovative mucoadhesive buccal tablet
delivering very high concentrations of the active ingredient in mucosa and lips, sites of the herpes
The efficacy of Sitavig® has been validated with a pivotal phase III clinical trial conducted in 775
patients that showed a significant reduction in the occurrence of vesicular lesions (p=0.043), in the
time to healing of vesicular lesions (p=0.015), in the herpes episode duration (p=0.0038) and in the
severity of symptoms(p=0.008). 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 (p=0.04).