BioAlliance Pharma SA (Euronext Paris – BIO), a company dedicated to specialty and orphan oncology products, today announces:
• Following PAR Strativa restructuring and change of strategy including recent acquisition of generic portfolio, BioAlliance Pharma has decided to regain full US commercialization rights for Oravig®. The transfer, with no significant impact on BioAlliance Pharma short and medium term revenues, will be effective October 2011. It allows BioAlliance to enter in discussion with potential partners involved in supportive care oncology for this valuable asset.
Oravig®, recently FDA approved, is an innovative mucoadhesive buccal tablet specially designed to deliver high local concentrations of miconazole. It is effective against oropharyngeal candidiasis, highly incident among cancer patients during chemo-radiotherapy (20% to 70% of patients depending upon cancer types), and particularly against resistant candida strains.
• BioAlliance Pharma has obtained green light for Livatag® phase III clinical trial from the French regulatory Agency which represents a key milestone in the clinical development of this drug, which is leading the orphan oncology portfolio.
Livatag® has been conceived to overcome drug resistance thanks to its innovative proprietary technology, and has already demonstrated efficacy on resistant models especially in primary liver cancer, highly chemoresistant. Based on phase II promising survival results (17 months additional survival versus comparative group) and new models-validated proprietary infusion scheme aiming to manage respiratory severe adverse effects, BioAlliance will perform a multicenter international phase III study including 400 patients suffering from Hepato Cellular Carcinoma, resistant or intolerant to sorafenib. The primary objective is to demonstrate increased overall survival. Adequate patient safety monitoring will allow defining Livatag® risk benefit ratio versus standard of care.
This green light from French regulatory authorities enables BioAlliance to confirm announced timelines for Livatag® development with the phase III initiation planned in 2012.
“These two events are important for our value creation strategy: Oravig® decision will allow us to fully express the product commercial potential selecting a partner dedicated to supportive care oncology, ready to devote adequate resources to Oravig® success” comments Judith Greciet, CEO of BioAlliance Pharma. “On the other hand, the positive Agency decision to authorize Livatag® phase III clinical trial is a key step to our orphan oncology portfolio development strategy. With sales potential above 800 million Euros, Livatag® leads this orphan portfolio and should open BioAlliance access to its own revenues in these attractive markets”.
About Livatag® (doxorubicin Transdrug™)
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).