医療従事者の為の最新医療ニュースや様々な情報・ツールを提供する医療総合サイト

PARIS

Regulatory News:

BioAlliance Pharma SA (Paris:BIO) (Euronext Paris – BIO), an innovative Company dedicated to the development of orphan oncology products, announced today a major strengthening of the patent protection for its product Livatag® (doxorubicine Trandrug™), currently in phase III clinical trial in primary liver cancer (ReLive trial).

The European Patent Office has issued a new patent family for Livatag® protecting its specific administration scheme. This first delivery should be followed by many others since the patent application is under review in about twenty other territories worldwide (including the United States, Asia and Latin America).

Livatag® was already patented until 2019 on an international level with a first patent family protecting its composition (doxorubicin encapsulated in nanoparticles). It also benefits from a commercial exclusivity linked to its orphan status in Europe and in the United States, which covers from 7 to 10 years from the market authorization.

This second patent family significantly strengthens and extends Livatag®’s protection as it expands it until 2031, until which period no generic may be commercialized.

« This new patent has not only reinforced but has also strongly extended the protection of Livatag®. This represents a significant additional potential of revenues for such a product whose estimated level of sales could reach up 800 million euros,” commented Judith Greciet, CEO of BioAlliance Pharma.

« We are very pleased with the delivery of this new patent for Livatag®, the fruit of a very close collaboration between the Company’s Development and Industrial Property teams. These constant interactions allow us to ensure an optimal patent protection to our programs, thereby maximizing permanently their valorization,” added Aude Michel, Head of Corporate Development at BioAlliance Pharma.

About BioAlliance Pharma

Dedicated to cancer treatments with a focus on resistance targeting and orphan products, BioAlliance Pharma conceives and develops innovative products 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.

BioAlliance Pharma has developed an advanced product portfolio:

Orphan Oncology products
Livatag^® (Doxorubicin Transdrug™) (primary liver cancer): Phase III on going
Validive^® (Clonidine Lauriad^®) (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

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 2012 Reference Document filed with the AMF on April 18, 2013, which is available on the AMF website (http://www.amf-france.org) or on BioAlliance Pharma SA’s website (http://www.bioalliancepharma.com).