BioAlliance Pharma initiates the clinical batches production of Livatag® (doxorubicin Transdrug™) for its phase III clinical trial

BioAlliance Pharma SA (Euronext Paris – BIO), a company
dedicated to specialty and orphan oncology products, today announces the initiation of the
clinical batches production of Livatag® (doxorubicin Transdrug™) for its phase III clinical trial
in primary liver cancer.
This production will be performed by qualified companies for injectable cytotoxic products in
nanoparticle form. The BioAlliance Pharma’s team specialized in industrial development, who
previously performed scale up of the technology, will collaborate with its partners throughout
the process to ensure the transmission of its know-how specific to nanoparticle Transdrug™
The production of clinical trial batches is one of the milestones of Livatag® phase III clinical
trial in primary liver cancer, last development step of the product.
The Company has enlarged the protection of its Transdrug™ technology with the grant of a
second European patent. This strengthens the industrial property of Livatag® and completes
the market exclusivity given by the orphan status, thus reinforcing the value of this key asset
for the Company.
“The BioAlliance Pharma’s industrial development team and its European partners have
been fully committed to prepare the clinical production of Livatag®, relying on their specific
nanotechnology expertise and know-how”, declares Judith Greciet, CEO of BioAlliance Pharma.
About BioAlliance’s partners in the production of Livatag®
NextPharma (UK, Belgium) proposes, in its Sterile Product Development Center (SPDC), its knowhow
and its expertise in the field of pharmaceutical manufacturing of sterile cytotoxic product for parenteral
use, in accordance with the requirements of US FDA, EMEA and other major regulatory agencies.
AMATSI (Belgium) is a pharmaceutical Contract Development and Manufacturing Organization
(CDMO) which offers its knowhow and its expertise in a large suite of services including the galenic
and analytic development, the quality control and the clinical supplies manufacturing packaging and
Quality Assistance is a Contract Research Organization specialized in characterization, analytical
development and quality control. In business since 1982, it helps the pharmaceutical and
biopharmaceutical industries bring their products efficiently onto the market. It employs 115 highly
qualified professionals working in premises of 5200 m² including 6 laboratories on one site, Mass
Spectrometry, Physico-chemistry, Bioanalysis (PK/TK), Cell Culture, Molecular Biology and
Microbiology. Compliant with GMP, GLP and GCLP, Quality Assistance has been successfully
inspected by the FDA (US), PMDA (Japan) and the European regulatory authorities.
About Livatag®
Primary liver cancer, or hepatocellular carcinoma, is the fifth cancer in incidence and the third leading
cause of cancer deaths worldwide. This cancer is highly chemo-resistant, very often diagnosed at an
advanced stage and still represents a high unmet medical need.
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.
Livatag® is today the leader in the orphan oncology products portfolio, also including clonidine
Lauriad™ in the prevention of radiotherapy-induced oral mucositis in patients with head and neck
cancer (phase II) and AMEP® in metastatic melanoma (phase I).