BioAlliance Pharma files for European marketing authorization for ondansetron RapidFilm™ in supportive care in cancer

BioAlliance Pharma SA (Euronext Paris: BIO), the specialty
pharmaceutical company focused on the treatment of opportunistic infections in cancer and
AIDS, today announced the initiation of its European marketing application for ondansetron
RapidFilm™, the fast-dissolving oral film strip formulation of ondansetron (which until now
has been used in tablet form). This innovation is designed to prevent and treat nausea and
vomiting induced by chemotherapy and radiotherapy. Ondansetron RapidFilm™ facilitates
administration of the drug and improves efficacy and patient compliance.
The ondansetron film uses the RapidFilm™ drug delivery technology developed in joint
venture by APR Applied Pharma Research s.a. (“APR”) of Switzerland and Labtec GmbH of
Germany and enables novel oral dosing via a fast-dissolving film strip. The formulation is
particularly suitable for patients with nausea or who have trouble swallowing.
In Europe, antiemetic drugs represent the main component of cancer supportive care and
accounted for annual sales totaling over €400 million in the five largest markets in 2007i.
Ondansetron was the leading drug in its class in 2007, with around 800,000 prescriptionsii.
BioAlliance Pharma estimates that the decentralized registration procedure (covering 16
European countries) should take between 9 and 12 months.
Dominique Costantini, BioAlliance Pharma’s President and CEO, stated that “filing for
marketing authorization in Europe via a decentralized procedure is a key milestone for our
company on the road to commercialization of this new product. Our pharmaceutical, clinical
and regulatory teams are fully committed to driving this application forward”.
“RapidFilm™ technology aims to provide the quickest, easiest and most patient friendly way
for the oral intake of drugs,” said Paolo Galfetti CEO of APR. “Ondansetron was an ideally
candidate to maximize both the patient and the market value of such feature and we believe
BioAlliance is the best partner to bring this opportunity to a successful outcome in the