APPLICATION FILED FOR PHASE III ANTIFUNGAL TRIAL

BioAlliance Pharma, a biopharmaceutical company focused on the field of drug resistance, announced today that it has submitted an Investigational New Drug Application (IND) to the FDA to conduct a pivotal Phase III clinical trial of its antifungal agent, miconazole Lauriad. This is a once-daily 50 mg extended-release Bioadhesive Buccal Tablet that is being investigated as a first-line local treatment for oropharyngeal candidiasis (OPC), an oral fungus.

OPC infections are frequent within immunocompromised populations, such as those represented by cancer therapy, HIV-infection, ICU and transplant patients, diabetes mellitus, and denture use. Pending clearance by the FDA, BioAlliance intends to initiate the Phase III trial in the fourth quarter of 2005. The pivotal Phase III trial in HIV-positive patients will be conducted under the Section 505(b)(2) approval mechanism, allowing for a single Phase III trial based on previous approval of a drug product (miconazole) through reliance upon the FDA's prior findings of safety and efficacy together with third party data on safety and effectiveness available in the published literature.