BioAlliance Pharma SA (Euronext Paris: BIO), a company dedicated to the
treatment of cancer and AIDS patients and supportive care, today announced the submission of its
New Drug Application (NDA) to the United States Food and Drug Administration (FDA), as planned,
for the approval of Loramyc®, Mucoadhesive Buccal Tablets (MBT), developed for the treatment of
OroPharyngeal Candidiasis. If approved, Strativa Pharmaceuticals, the specialty pharma division of
Par Pharmaceutical, Inc. (NYSE: PRX), the BioAlliance Pharma’s partner for commercialization in
the USA, could launch Loramyc® in the second half of 2010.
« Loramyc® has already received a Market Authorization in 11 European countries and is currently
marketed in France. This NDA filing at the FDA is an important milestone on the road to
commercialization in the USA in 2010 via our partner Par Pharmaceutical/Strativa – a company that
is already well established in the AIDS and cancer supportive care market», emphasized Dominique
Costantini, BioAlliance Pharma’s President and CEO.
In addition, BioAlliance Pharma is notifying its shareholders of an upcoming General Assembly
meeting. Among the resolutions to be presented will be the change of the by-laws including the
change of the dual structure “Directoire/’Conseil de surveillance” into the more classical Board
structure. BioAlliance aims therefore at simplifying its governance structures for a better reactivity in
front of its new challenges. The Board structure is also the most used among French listed
companies. The official notice of the Meeting will be published in the French Republic’s Bulletin des
Annonces Légales Obligatoires (“Bulletin of Mandatory Legal Announcements”) in the coming days.
The Assembly should be held in at least the next 35 days following the notice.