Paris, November 17, 2010 – BioAlliance Pharma SA (Euronext Paris – BIO), a company dedicated to the supportive care and treatment of cancer patients, presented the results of the pharmacokinetic study on its Sitavir® (acyclovir Lauriad® 50mg), developed for the treatment of recurrent oro-facial herpes, at the “FIP Pharmaceutical Sciences World Congress (PSWC) 2010 in association with the AAPS (American Association of Pharmaceutical Scientists) Annual Meeting and Exposition”.
This pharmacokinetic study showed that after one single application of Sitavir ® mucoadhesive buccal tablet, acyclovir concentrations in saliva and labial mucosa were rapidly detected (within 30 minutes). These concentrations on the muco-cutaneous infection site have been sustained over 24 hours whereas plasma concentrations were very low. These results support the administration of one single dose of Sitavir® as soon as the first oro-facial herpes infection symptoms or signs occur. The efficacy of one single dose of Sitavir® for the treatment of recurrent oro-facial herpes has been confirmed in the pivotal phase III clinical trial including over 700 patients.
“These data confirm the interest of mucosal targeting obtained with our mucoadhesive buccal Lauriad® technology”, comments Dominique Costantini, Chief Executive Officer of BioAlliance Pharma. “This technology, protected by several families of patents over the long term, has enabled us to develop two innovative products: Loramyc® (Oravig® in the US), dedicated to the treatment of oropharyngeal fungal infections and registered in 28 countries, and Sitavir®, dedicated to the treatment of recurrent herpes labialis infections whose registration dossier submission is planned in 2011. Today, with two other innovative products already in clinical phase, fentanyl Lauriad® and clonidine Lauriad®, BioAlliance is capitalizing on its mucosal know-how and on the good tolerance observed. The company is accelerating the development of products in new markets, opening the path to additional revenues”.
About FIP Founded in 1912, the International Pharmaceutical Federation (FIP) is the global federation of national associations of pharmacists and pharmaceutical scientists in official relations with the World Health Organization (WHO).
About the American Association of Pharmaceutical Scientists (AAPS) The purpose of AAPS is to serve its membership, the pharmaceutical sciences, the biomedical and biotechnological community, the health professions, and the interest of public health. This is accomplished by providing open forums for the exchange and dissemination of scientific knowledge; by fostering the education and career growth of members and recognizing individual achievement; by influencing the formation of public policy relevant to health and related issues of public concern; and, by promoting the pharmaceutical sciences as they relate to health issues of public concern.
About BioAlliance Pharma
Dedicated to cancer and supportive care – cancer related pathologies, chemotherapy and radiotherapy-induced complications and opportunistic infections in immunocompromised patients – BioAlliance conceives and develops innovative products, especially in the hospital setting and for orphan or rare diseases. Created in 1997 and introduced to the Euronext Paris market in 2005, BioAlliance Pharma’s ambition is to become a leading player in these fields by coupling innovation to patient needs. The company’s teams have the key competencies required to identify, develop and register drugs in Europe and the USA; the products’ commercialization rights are licensed to international commercial partners invested in the hospital setting. In areas where medical needs are insufficiently met, its targeted approaches help overcome drug resistance and improve patient health & quality of life.
BioAlliance Pharma has developed an advanced product portfolio: Loramyc®/Oravig® (oropharyngeal candidiasis in immunocompromised patients): Registered in 26 European countries, in Korea and in the United States Setofilm® (prevention and treatment of -chemotherapy, radiotherapy and post operative- induced nausea and vomiting in adults and children): Registered in 16 European countries Acyclovir Lauriad® (labialis herpes): Positive phase III final results; registration status Fentanyl Lauriad® (chronic cancer pain): Positive preliminary Phase I results AMEP® (invasive melanoma): Phase I Clonidine Lauriad® (mucositis): Phase II Doxorubicin Transdrug® (liver cancer): Phase II For more information, visit the BioAlliance Pharma web site at www.bioalliancepharma.com 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 2009 Reference Document filed with the AMF on June 29, 2010, which is available on the AMF website (http://www.amf-france.org) or on BioAlliance Pharma SA’s website (http://www.bioalliancepharma.com).
BioAlliance Pharma SA Dominique Costantini, CEO Tel.: +33 1 45 58 76 01 dominique.costantini@bioalliancepharma.com Nicolas Fellmann, CFO Tel.: +33 1 45 58 71 00 nicolas.fellmann@bioalliancepharma.com
ALIZE RP Caroline Carmagnol Tel.: +33 6 64 18 99 59 caroline@alizerp.com
