27.05.2013 20:12:00

BioAlliance Pharma presents results on Sitavig® at the 10th EADV symposium

Regulatory News:

BioAlliance Pharma SA (Euronext Paris - BIO), a Company dedicated to the development of orphan oncology products and supportive care products, has presented the results of the pharmacokinetic and pharmacodynamic study on Sitavig® at the 10th EADV spring symposium (European Academy of Dermatology and Venereology) in Cracow (Poland) on May 24, 2013.

"This study has shown that Sitavig®, a mucoadhesive buccal tablet, delivers early, very high and prolonged concentrations of acyclovir at the replication site of the herpes virus. Salivary and labial acyclovir concentrations are markedly over those obtained with the other antiviral drugs,” declares Pierre Attali, COO of BioAlliance Pharma in charge of Strategy and Medical affairs. "This pharmacokinetic profile supported the rationale for a single administration of Sitavig® to treat cold sores as soon as the first signs or symptoms occur.

Together with the marked efficacy on healing time and on pain as well as an excellent safety profile demonstrated in the international phase III trial (LIP study). These results enabled to obtain the registration of Sitavig® in 8 first European countries and in the United States.

In addition to its efficacy, Sitavig® offers a unique discreet and simple formulation with a single application, representing major advantages for patients suffering from recurrent cold sores.

"Sitavig® is the second drug of BioAlliance’s Specialty products portofolio to have obtained a market authorization in Europe and the United States. With a market potential of hundreds of millions of dollars, we are searching a partner to commercialize Sitavig® notably in the United States, which would enable to generate significant revenues to the company,” declares Aude Michel, Head of Corporate Business Development.

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.

BioAlliance Pharma has developed an advanced product portfolio:

Specialty products
Loramyc®/Oravig® (oropharyngeal candidiasis in immunocompromised patients): Registered in 26 countries (EU, US, Korea), commercialized in Europe and in the USA.
Sitavig® (Acyclovir Lauriad® / herpes labialis): Registered in the USA and in 8 European countries, registration status in the other European countries.
Fentanyl Lauriad® (chronic cancer pain): Positive preliminary Phase I results

Orphan Oncology products
Livatag® (Doxorubicin Transdrug™ / primary liver cancer): Phase III on going
Validive® (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.

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 2011 Reference Document filed with the AMF on April 24, 2012, which is available on the AMF website (http://www.amf-france.org) or on BioAlliance Pharma SA's website (http://www.bioalliancepharma.com).

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