PARIS--(BUSINESS WIRE)-- Regulatory News:
BioAlliance Pharma SA (Euronext Paris - BIO) (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™ technology.
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 distribution.
Quality Assistance is a Contract Research Organization specialized in analytical development and quality control which helps the pharmaceutical and biopharmaceutical industries to bring their products efficiently onto the market.
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).
About BioAlliance Pharma
Dedicated to cancer and supportive care treatment with a focus on resistance targeting and orphan products –– BioAlliance conceives and develops innovative products, for specialty markets 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 28 countries (EU US, Korea)
Sitavir® (Acyclovir Lauriad TM) (labialis herpes): Positive phase III final results; registration status
Fentanyl LauriadTM (chronic cancer pain): Positive preliminary Phase I results
Orphan Oncology products
Livatag® (Doxorubicin Transdrug™) in primary) liver cancer: Phase II results on survival
Clonidine LauriadTM (mucositis): Phase II on going
AMEP® (invasive melanoma): Phase I on going
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 2010 Reference Document filed with the AMF on April 7, 2011, 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
Judith Greciet, CEO
Tel +33 1 45 58 76 00
Nicolas Fellmann, CFO
Tel.: +33 1 45 58 71 00
Tel.: +33 6 64 18 99 59
KEYWORDS: United States Europe North America France
INDUSTRY KEYWORDS: Health Biotechnology Oncology Pharmaceutical