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
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
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
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).
Contact: BioAlliance Pharma SA
Dominique Costantini, CEO
Tel.: +33 1 45 58 76 01
dominique.costantini@bioalliancepharma.com
or
Nicolas Fellmann, CFO
Tel.: +33 1 45 58 71 00
nicolas.fellmann@bioalliancepharma.com
or
ALIZE RP
Caroline Carmagnol
Tel.: +33 6 64 18 99 59
caroline@alizerp.com
Posted: March 2011
