BioAlliance Pharma: Livatag (Doxorubicin Transdrug) Follow up Demonstrates Significant Survival Increase in Advanced Hepatocellular Carcinoma Patients
PARIS--(BUSINESS WIRE)--Mar 31, 2011 - Regulatory News:
BioAlliance Pharma SA (Paris:BIO) (Euronext Paris - BIO), a company dedicated to the supportive care and treatment of cancer patients, today announced the update of its preliminary positive survival data with Livatag® (doxorubicin Transdrug™).
Livatag® is a treatment presented in nanoparticles able to deliver doxorubicin in chemoresistant cells. Livatag® was granted an orphan drug status in Europe and in the United States. The product is being evaluated in patients (via hepatic intra-arterial route) with advanced hepatocellular carcinoma, described as highly chemoresistant. Hepatocellular carcinoma (primary liver cancer) is the third cause of cancer mortality worldwide.
BioAlliance Pharma phase II follow up results showed a median survival of 32 months for Livatag® group, as compared with 15 months for patients getting current best of care (TACE transarterial chemoembolisation with a cytotoxic drug). This significant 17 months difference in the median survival is the basis for strong renewed interest in the product while on clinical hold.
BioAlliance Pharma is also pleased to announce the successful development of proprietary new Intravenous administration of Livatag® validated in animal models, which reduces acute pulmonary adverse events that led to the clinical hold. Livatag® new administration rationale jointly with the survival benefit observed will be presented to the French Drug Agency by Q2 2011. The company intends to communicate the final complete data in a specialized international congress.
“We believe that these new achievements are paving the way for a constructive dialog with health authorities, taking into account the impressive survival benefit in this severe resistant disease. Livatag® is perfectly in line with our orphan product strategy and could be a significant value catalyst for the company” said 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
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
Sitavir® (Acyclovir Lauriad TM) (labialis herpes): Positive phase III final results; registration status
Fentanyl LauriadTM (chronic cancer pain): Positive preliminary Phase I results
AMEP® (invasive melanoma): Phase I
Clonidine LauriadTM (mucositis): Phase II
Doxorubicin Transdrug™ (liver cancer): Phase II
For more information, visit the BioAlliance Pharma web site at www.bioalliancepharma.com
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).
Contact: BioAlliance Pharma SA
Dominique Costantini, CEO
Tel.: +33 1 45 58 76 01
Nicolas Fellmann, CFO
Tel.: +33 1 45 58 71 00
Tel.: +33 6 64 18 99 59
Posted: March 2011