BioAlliance Pharma Strengthens Livatag® pAtent Protection in Japan Until 2032

Regulatory News:

BioAlliance Pharma SA (Paris:BIO), an innovative Company specialized in the development of drugs in orphan oncology diseases, today announced the issuance of a new patent in Japan strengthening the industrial property protection of Livatag® (doxorubicin Transdrug™), currently being developed in primary liver cancer.

Livatag® was already patented until 2019 with a first patent family covering the pharmaceutical product’s composition. The second one covers the specific administration scheme of Livatag®, strengthening and extending its patent protection until 2032. This new issuance from the Japanese patent office comes in addition to the one already delivered in Europe.

Moreover, Livatag® benefits from additional market exclusivity related to its orphan status, for 10 years in Europe and 7 years in the U.S. from the date of market authorization.

« This new patent reinforces the already well-established industrial protection of Livatag® and recognizes the innovation of its administration scheme. It also demonstrates our capacity to set up a strong IP around our strategic program “, declared Aude Michel, Head of Corporate Development of BioAlliance Pharma.

Primary liver cancer, also called hepatocellular carcinoma, is a particularly aggressive chemo-resistant cancer. It is the second leading cause of cancer-related deaths worldwide, few therapeutic alternatives are available and there is a significant unmet medical need. While the disease is classified as an orphan disease in Europe and in the U.S., its incidence is very high in Asian countries, and especially in Japan where there are about 36.000 new cases per year.

Livatag® is currently in a phase III trial in Europe and in the U.S. (ReLive trial), expected to be completed end of 2016.

“Japan represents a significant market for Livatag® and is a key country to establish product’s footprint in Asia. The strengthened and extended patent protection in Japan enhances the value of this drug which is at an advanced stage of its clinical development and has significant sales potential”, added Judith Greciet, CEO of 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®/Synfoldin (invasive melanoma): Clinical and Preclinical Phase

BioAlliance Pharma has announced a merger project with the Danish listed company Topotarget on April 16th 2014.
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 2013 Reference Document filed with the AMF on April 7, 2014, which is available on the AMF website (http://www.amf-france.org) or on BioAlliance Pharma SA's website (www.bioalliancepharma.com).