BioAlliance Pharma: Files IND for US Pivotal Phase III Trial

BioAlliance Pharma Files IND for US Pivotal Phase III Trial of Miconazole Lauriad(R) for Treatment of Oropharyngeal Candidiasis

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 U.S. Food and Drug Administration (FDA) to conduct a pivotal Phase III clinical trial of its antifungal agent, miconazole Lauriad(R). This is a once-daily 50 mg extended-release Bioadhesive Buccal Tablet 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 miconazole Lauriad IND filing represents the accomplishment of one of our key objectives for 2005, and we are looking forward to advancing this product through the clinic as we have already done in the EU,” said Dominique Costantini, M.D., president and CEO of BioAlliance Pharma. “The rationale for development of an extended-release bioadhesive buccal tablet is to reach a constant antifungal salivary concentration, increase contact time with effective drug concentrations and reduce the risk of resistance while providing for once-daily administration to improve patient compliance.”

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. As part of the IND filing, BioAlliance will also submit the results of two completed Phase III trials conducted in the EU, one in head & neck cancer patients following radiotherapy and the other in HIV-positive patients.

About BioAlliance Pharma

BioAlliance Pharma is a privately held late stage biopharmaceutical company focused on drug resistance through development and commercialization of innovative therapeutics targeting markets in cancer, HIV, severe infections and supportive care. The company has two broad proprietary drug delivery systems represented by the Lauriad(R) adhesive technology and the Transdrug(R) nanoparticle technology that provide multiple product opportunities. Together with a New Chemical Entities program focused on development of new drugs in oncology and HIV, the company is able to address worldwide markets in the EU, US, and Asia.

The company’s lead product within its adhesive technology program, the miconazole Lauriad(R) 50 mg Bioadhesive Buccal Tablet, is being investigated in two recently completed Phase III trials in Europe for treatment of oropharyngeal candidiasis in cancer and HIV patients. EU registration is on track for filing in Q3 2005 and a pivotal Phase III trial in the same indication is planned to start in the U.S. later this year. A near term follow-on product, acyclovir Lauriad(R) for treatment of oral herpes, using the same delivery system, entered a Phase I clinical trial in April in the EU. A Phase I/II trial in hepatocellular carcinoma utilizing the company’s doxorubicin Transdrug(R) nanoparticle delivery technology is ongoing in Europe, and has been granted orphan drug status by the EMEA and the US FDA.

For additional company background, please visit the BioAlliance Pharma web sites at: www.BioAlliancepharma.com and www.viralliance.com.