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BioAlliance Pharma First Meeting of the International Advisory Board on Oral Mucositis and Development of Validive®

9/30/2013 1:13:52 PM

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Paris, September 30, 2013 - BioAlliance Pharma SA (Euronext Paris - BIO), an innovative company dedicated to the development of orphan oncology products and to supportive care products, held the first meeting of its international Advisory Board dedicated to oral mucositis and to the associated clinical development program with Validive® (clonidine Lauriad®).

This multidisciplinary Advisory Board is composed of internationally recognized European and American experts, in the fields of oral mucositis and oral medicine, oncology and radiotherapy: Drs Stephen Sonis (Boston, Massachusetts), Paolo Bossi (Milano, Italy), Joel Epstein (LA, California), Jorge Giralt Lopez del Segredo (Barcelona, Spain) and Michael Henke (Freiburg, Germany). Its purpose is to provide advice and input on development strategy and medical positioning of Validive® in oral mucositis.

Validive® is currently being developed for the prevention and treatment of chemoradiation therapy-induced oral mucositis in patients with head and neck cancer. The Phase 2 international, double blind, placebo controlled study being conducted in Europe and in the US has enrolled nearly 75% of planned patients. Recruitment should be completed early in 2014 with results and analyses completed later in the year expected to represent a major step towards the validation of Validive®. The Advisory Board will assist BioAlliance Pharma with Validive®’s development strategy and has started assessing the most relevant strategic path from ongoing Phase II to registration.

“Validive®’s biological activities are consistent with the interruption of pathways known to be important in the development of mucositis. Coupled with its unique formulation, Validive® could become an attractive option for the prevention of oral mucositis, a severe treatment complication for which no preventive treatment is currently available,” comments Stephen Sonis.

“Moreover, this panel of worldwide scientific and medical experts in oncology treatment-induced oral mucositis will help us design the future trials with Validive®, a key asset in our Orphan Oncology portfolio, to meet patients’ needs and help us to maximize the potential of Validive® in this disabling disease,” adds Pierre Attali, BioAlliance Pharma’s Chief Operating Officer in charge of strategy and medical affairs.

About Severe Oral Mucositis

Severe oral mucositis is a particularly invalidating pathology occurring in more than 60% of patients treated with radio/chemotherapy for head and neck cancer and has currently no validated curative or preventive treatment. It may induce intense oral pain and eating disability requiring enteral or parenteral nutritional support. Thirty percent of patients need to be hospitalized as a result and symptoms can force patients to stop treatment for an undefined period thus reducing treatment efficacy.

About BioAlliance Pharma

Dedicated to cancer and supportive care treatment with a focus on resistance targeting and orphan products, BioAlliance Pharma 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 US.

Sitavig® (Acyclovir Lauriad®) (labialis herpes): Registered in the US 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 Lauriad®) (mucositis): Phase II on going

AMEP® (invasive melanoma): Phase I on going

For more information, visit the BioAlliance Pharma web site at


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 ( or on BioAlliance Pharma SA's website ().

BioAlliance Pharma SA

Judith Greciet, CEO

Nicolas Fellmann, CFO

Tel.: +33 1 45 58 76 00


Caroline Carmagnol

+33 6 64 18 99 59

Christian Berg

+33 6 31 13 76 20

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