Paris, August 26th, 2010 - BioAlliance Pharma SA (Euronext Paris - BIO), a company dedicated to the supportive care and treatment of cancer patients, today announces that the US Food and Drug Administration (FDA) considers the positive results of the pivotal phase III study with acyclovir Lauriad® acceptable to submit a 505(b)(2) New Drug Application of the product in the United States.
Acyclovir Lauriad®, BioAlliance Pharma second product using the Lauriad® technology (Mucoadhesive Buccal Tablet), has been developed for the treatment of recurrent herpes labialis on the basis of one and only one tablet application as soon as the first signs of infection appear. As announced beginning of July, the European file submission is planned for mid-2011 based on the same clinical programme.
“This notification from the FDA confirms that acyclovir Lauriad® represents an innovation in the treatment of oro-facial herpes labialis and strengthens our position to find the adequate partner targeting dermatologists and general practitioners to successfully commercialize this opportunity”, declares Dominique Costantini, CEO of BioAlliance Pharma.
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
Fentanyl Lauriad® (Chronic cancer pain): Positive preliminary Phase I results
AMEP® (Invasive melanoma): Phase I
Clonidine Lauriad® (Mucositis): Phase II
Doxorubicine 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
