Scientific Results Presented at ICAAC Demonstrate theWell-differentiated Profile and Broad Spectrum of BioAlliancePharma's Antifungal
Data presented at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) show antifungal profile suited to clinical resistance issues
PARIS, September 17, 2007 - BioAlliance Pharma SA (Euronext Paris - Code Isin: FR0010095596 -BIO), a specialty pharmaceutical company focused on the development and marketing of innovative therapeutics targeting cancer, HIV, opportunistic infections and drug resistance, presented new data at ICAAC today, which highlight the mycological profile of miconazole, active principle of BioAlliance Pharma's antifungal. These results show that in vitro repeated exposure to miconazole does not induce fungal resistance. It confirms the potent and broad activity of this antifungal agent.
Resistant Candida albicans and non-albicans strains are growing problems encountered during antifungal therapy. Therefore, it is important for clinicians to be aware of the antifungal resistance profile. The widespread use of fluconazole is being incriminated in the selection and development of resistant strains of Candida albicans and in the increase in the incidence of non-albicans species in immuno-compromised patients.
The microbiological miconazole study conducted by Professor M.A. Ghannoum (from the Center for Medical Mycology of the University Hospitals of Cleveland, Cleveland, OH, US) and presented at ICAAC, was a resistance induction study. Its objective was to determine whether repeated exposure to miconazole (for a total of 15 passages) of Candida species, including fluconazole-susceptible and fluconazole-resistant strains, resulted in development of resistance against this antifungal. Clinical Candida isolates from the oral cavity were selected and included one fluconazole-resistant and one fluconazole-susceptible strain each of C. albicans, and C. non-albicans. The Minimum Inhibitory Concentration (MIC) (or effective concentration) of miconazole against each isolate was determined.
The results showed that in vitro repeated exposure to miconazole did not induce resistance of Candida species. Fluconazole-resistant strains of Candida were and remained sensitive to miconazole despite repeated administrations.
These data specified the antifungal resistance profile and confirmed the potent activity of BioAlliance Pharma's antifungal miconazole, presented at ECCMID in March 2007. The ECCMID study, also carried out by Pr Ghannoun, already established the profile of miconazole and compared it to other antifungals, including new azoles. It showed that miconazole demonstrated potent inhibitory activity against all of the Candida species tested selected from recent clinical isolates (including fluconazole-resistant isolates).
This well-differentiated antifungal profile allows BioAlliance Pharma antifungal, miconazole Lauriad(R), to be used as the first line of treatment of oropharyngeal candidiasis in immuno-compromised patients, in agreement with the international experts' recommendation to use an effective local antifungal treatment with a spectrum extended to all Candida species, thus avoiding resistance issues.
About BioAlliance Pharma BioAlliance Pharma SA (Euronext Paris - Code Isin: FR0010095596 -BIO) is a specialty pharmaceutical company focused on the development and commercialization of innovative therapeutics targeting cancer, HIV, opportunistic infections and drug resistance.
The company is currently conducting 3 phase III clinical trials on innovative products. Two products are based on the Lauriad(R) mucoadhesive technology, which allows an early and prolonged release of therapeutic agents at the site of the disease: one authorized product in France and two clinical international phase III trials ongoing (Loramyc(R) and aciclovir Lauriad(R)). One product is based on the Transdrug(R) nanoparticle technology designed specifically for intracellular targeting: one international phase III trial ongoing on primary liver cancer (doxorubicin Transdrug(R)). The company develops also a New Entities program focused on new targets in oncology and HIV. The company concluded two strategic partnerships in 2007 to sell its Loramyc(R) product in Europe and in the US. Loramyc(R) has recently been launched on the French market.
About BioAlliance antifungal miconazole Lauriad(R) BioAlliance antifungal miconazole Lauriad(R) is the first antifungal once-daily muco-adhesive buccal tablet indicated in oral candidiasis of immuno-compromised patients. Its innovative delivery system permits local and targeted delivery on the oral mucosa. BioAlliance antifungal miconazole Lauriad(R) has been commercialized in France since September 2007 and is in phase III development in US for the treatment of oropharyngeal candidiasis.
Disclaimer This communication expressly or implicitly contains certain forward-looking statements concerning BioAlliance Pharma SA and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of BioAlliance Pharma SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. BioAlliance Pharma SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
For a discussion of risks and uncertainties which could cause actual results, financial condition, performance or achievements of BioAlliance Pharma SA to differ from those contained in the forward-looking statements please refer to the Risk Factors (Facteurs de Risque) section of the reference document approved by the AMF on 6 April 2007 under the number R. 07-031, which is available on the AMF website www.amf-france.org or BioAlliance Pharma S.A.'s website <http://www.bioalliancepharma.com>www.bioalliancepharma.com.
Brighton Business Centre 95 Ditchling Road Brighton BN1 4ST ENGLAND Tel: +44 1273 675100 Fax: +44 1273 675400
55 rue Boissonade 75014 Paris FRANCE Tel: +33 1 56 54 07 00 Fax: +33 1 56 54 07 01
Posted: September 2007