09/2005 Press Release

BioAlliance Pharma Announces FDA Allowance of IND for US Pivotal Phase III Trial of Miconazole Lauriad® for Treatment of Oropharyngeal Candidiasis

PARIS - September 6, 2005 - BioAlliance Pharma, a biopharmaceutical company focused on the field of drug resistance, announced today that the Company’s Investigational New Drug Application (IND) to conduct a pivotal Phase III clinical trial of its antifungal agent, miconazole Lauriad®, has been allowed by the U.S. Food and Drug Administration (FDA). Miconazole Lauriad® 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. BioAlliance intends to initiate the Phase III trial in the fourth quarter of 2005.

“FDA allowance of the miconazole Lauriad® IND for a pivotal Phase III study represents an important milestone in our efforts to expand development of this first product in the Lauriad line,” said Dominique Costantini, M.D., president and CEO of BioAlliance Pharma. “With our upcoming registration filing in the EU together with ongoing activities aimed at clinical development in Japan, we are rapidly expanding the potential global market for miconazole Lauriad® and, as regulatory approvals are obtained, the possibility of a new treatment option for physicians and their patients suffering from OPC.”

The pivotal Phase III trial will be conducted in HIV-positive patients 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 submitted 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® adhesive technology and the Transdrug® 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® 50 mg Bioadhesive Buccal Tablet, has been investigated in two completed Phase III trials in Europe for treatment of oropharyngeal candidiasis in cancer and HIV patients. EU registration is on track for filing
before the end of 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® for treatment of oral herpes, using the same delivery system, has recently completed Phase I clinical studies in the EU. A Phase I/II trial in hepatocellular carcinoma utilizing the company’s doxorubicin Transdrug® 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, click here.

Company Contact

Richard Keatinge
Vice President, Business Development
BioAlliance Pharma SA
Tel : +33 (0) 1 45 58 76 00
richard.keatinge@bioalliancepharma.com

Media Contact
Andrew Lloyd & Associates
Andrew Lloyd
Tel : +44 1 273 675100
Gilles Petitot
Tel : +33 1 56 54 07 00