BioAlliance Pharma: Results Presented at ECCO 2007 Further Confirm the Clinical Efficacy of BioAlliance Pharma's Antifungal, Particularly in Populations with High Risk of Candidiasis
New results from tests adjusted for risk factors showed a strong trend towards superiority in favor of miconazole Lauriad(R), in particular in patients with impaired saliva secretion or extended lesions.
BioAlliance Pharma carried out an international multicenter randomized Phase III trial in accordance with French Drug Agency recommendations, in 282 head and neck cancer patients previously treated with radiotherapy or chemotherapy and suffering from oropharyngeal candidiasis. The aim was to demonstrate that the miconazole 50mg mucoadhesive buccal tablet (miconazole Lauriad(R)) once daily was not inferior to miconazole 500mg oral gel four times per day.
Even with a risk factor imbalance weighted against miconazole Lauriad(R), results from these tests confirmed that the success rate after 14 days of treatment with miconazole Lauriad(R) (50mg) administered once daily was not-inferior to that of miconazole 500mg oral gel administered four times per day. A difference of 7.1 % was observed in favor of the miconazole Lauriad(R) group.
After researchers made adjustments for the risk factors related to the extent of mucous lesions and saliva secretion, the new results clearly establish the breakthrough due to delivery of BioAlliance Pharma miconazole Lauriad(R) at the infection site. The success rate at 14 days in patients suffering from multiple lesions is 58.7 percent for the miconazole Lauriad(R) group versus 37.5 percent with the gel. This efficacy is obtained with 10-fold lower doses of active principle administered just once a day.
These data suggest that miconazole Lauriad(R) can be used as first line therapy in cancer patients with oropharyngeal candidiasis, in line with international experts' recommendations to treat initial episodes of oropharyngeal candidiasis with topical treatments.
About BioAlliance Pharma BioAlliance Pharma SA (Euronext Paris: 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 acyclovir 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. BioAlliance Pharma has just announced the launch of Loramyc(R) on the French market.
About BioAlliance antifungal miconazole Lauriad® BioAlliance antifungal miconazole Lauriad(R) is the first antifungal once-daily mucoadhesive 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 www.bioalliancepharma.com. -- Juliette dos Santos ANDREW LLOYD & ASSOCIATES http://www.ala.com firstname.lastname@example.org
55 rue Boissonade 75014 PARIS FRANCE Tel : +33 1 56 54 07 00 Fax : +33 1 56 54 07 01
Brighton Business Centre 95 Ditchling Road Brighton BN 1 4ST ENGLAND Tel : +44 1273 675100 Fax : +44 1273 675400
Posted: September 2007