Presentations by BioAlliance Pharma at the 49th Annual ICAAC Conference on Results of Three Phase III Trials with LoramycTM

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Presentations by BioAlliance Pharma at the 49th Annual ICAAC Conference on Results of Three Phase III Trials with LoramycTM
Sunday, September 13, 2009Description :
BioAlliance Pharma SA (Euronext Paris - BIO), a company dedicated to the treatment of cancer and AIDS and supportive care, presented at the 49th Annual Conference of the Interscience Conference on Antimicrobial Agents and Chemotherapy, Held in San Francisco from September 12 to 15, the results of three Phase III trials with miconazole Lauriad® and data on its integrase inhibitor.

The results of the Phase III trial with LoramycTM (miconazole Lauriad®), an oral mucoadhesive gingival tablet, demonstrate the efficacy of Lauriad® miconazole not lower than that of the US reference comparator (clotrimazole pellets) in Oropharyngeal candidiasis (COP) in patients with AIDS. This is the largest trial ever conducted in this population.

The randomized, double-blind, double-blind trial compared the efficacy and tolerability of a daily intake of LoramycTM with clotrimazole administered 5 times daily in the treatment of COP for 14 days. The trial was conducted in 577 AIDS patients in 40 centers in the United States, Canada and South Africa. The results showed no significant differences between the two treatments on the clinical efficacy endpoints, including the primary endpoint: complete disappearance of signs and symptoms of COP. The tolerance of LoramycTM was good.

The results of two other European Phase III trials were also presented in two posters: "Miconazole Mucoadhesive Buccal Tablet for the Treatment of Oropharyngeal Candidiasis in Head and Neck Cancer Patients" and "Evaluation of Miconazole MucoAdhesive Buccal Tablet: Treatment for Oropharyngeal Candidiasis ".

"With a presentation on its novel early integrase inhibitor acting in synergy with the current integrase inhibitor on resistant HIV strains and three presentations on Loramyc®, targeted treatment at the site of infection and acting on Clinical resistances, BioAlliance confirms its expertise in the field of resistance to treatments, "says Pierre Attali, Director of Clinical Research and Medical Affairs of BioAlliance Pharma.

"If the registration file being evaluated is approved by the Food and Drug Administration (FDA), Strativa Pharmaceuticals, proprietary products branch of Par Pharmaceutical, Inc. (NYSE: PRX), our exclusive The USA, could market LoramycTM in the US market during the second half of 2010. Miconazole Lauriad® has already been registered in 12 countries in Europe and is marketed on the French market under the Loramyc® brand. Various pharmaceutical forms of miconazole have been marketed worldwide, but miconazole Lauriad® is the first local treatment of miconazole available in oral form in the United States for the benefit of immunocompromised patients, "adds Dominique Costantini, President of BioAlliance Pharma.

Oropharyngeal candidiasis is a common fungal oral infection of the patient whose immune defenses are impaired, especially patients with HIV / AIDS and those receiving cancer treatment. COP may trigger the development of lesions or inflammation of the mouth and may induce symptoms such as pain, burning, and / or impaired taste.

About BioAlliance Pharma

As a privileged partner of hospital specialists, BioAlliance Pharma is a company that develops and markets innovative products in France, including opportunistic infections, cancer, AIDS and complications of chemotherapy. Our targeted approaches, in areas where medical needs are insufficiently met, help combat drug resistance and improve the health and quality of life of patients. BioAlliance Pharma aims to become a leading player in these fields by making the link between innovation and patient need. For more information, visit the BioAlliance Pharma website at


This press release contains, either implicitly or expressly, certain forward-looking statements about BioAlliance Pharma SA and its business. These statements depend on certain known or unknown risks, uncertainties and other factors that could cause actual results, financial condition, performance or achievements of BioAlliance Pharma SA to differ materially from the results, financial conditions , Performance or achievements expressed or implied in such forward-looking statements.

BioAlliance is issuing this release on this date and does not undertake to update any forward-looking statements contained herein, whether as a result of new information, future events or otherwise. For a description of the risks and uncertainties that could cause actual results, financial conditions, performance or achievements of BioAlliance Pharma SA to differ materially from those contained in the forward-looking statements, please refer to the section "Risk Factors" Of the 2008 Reference Document filed with the Autorité des Marchés Financiers, the AMF, on April 7, 2009, which is available on the AMF's websites And the Company

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