BioAlliance Pharma Announces the Launch of Sitavig® in the United States by Its Partner Innocutis

And the granting of a new U.S. Sitavig® patent

PARIS--()--Regulatory News:

BioAlliance Pharma SA (Paris:BIO) (Euronext Paris - BIO), an innovative Company specialized in the development of drugs in orphan oncology diseases, today announced the launch of Sitavig® (acyclovir Lauriad®) in the United States by its commercial partner, Innocutis Holdings LLC, and the granting of a new U.S. Sitavig® patent by the United States Patent and Trademark Office.

A few weeks after the execution of a licensing agreement between the two companies, Innocutis has begun the promotion of Sitavig® in the U.S. for the treatment of labial herpes to dermatologists and top tier general practitioners.

Herpes labialis is an extremely widespread condition. Between 20% and 40% of the adult population suffer from recurrent cold sores (1), namely from 60 to 120 million people in the U.S., representing a market potential from 400 to 500 million dollars.

“The U.S. launch of Sitavig®, a drug from the R&D of BioAlliance Pharma, confirms once more our know-how in the development and registration of products in the U.S. We are very confident in Innocutis’ sales team commitment and know-how to successfully implement the product on the U.S. market”, commented Pierre Attali, COO of BioAlliance Pharma, in charge of Strategy and Medical Affairs.

“We were looking forward to this launch and our sales force is now deployed throughout the U.S. market to bring Sitavig® to the clinicians and provide patients with a new way to treat labial herpes”, commented Joe Pecora, CEO of Innocutis Holdings LLC.

Moreover, BioAlliance Pharma was recently granted a new U.S. patent covering Sitavig® and strengthening its U.S. protection. This patent completes a patent portfolio of 3 patents already issued and other pending applications, and confers a commercial exclusivity on Sitavig® until December 2029.

(1). Young TB, Rimm EB, D’Alessio DJ. Cross-sectional study of recurrent herpes labialis: prevalence and risk factors. Am J Epidemiol. 1988;127:612-625.

About Sitavig®

Based on proprietary Lauriad® technology and patented until 2029 in the major territories, comes in the form of a mucoadhesive tablet which the patient places on the gum and which delivers a high concentration of acyclovir directly to the lip, the site of the cold sore infection. In addition to its efficacy, Sitavig® offers the major advantage of a particularly unobtrusive and simple formulation with a single application for the episode’s entire duration, particularly adapted to patients suffering from recurrent herpes sores.

Sitavig® is one on the two « specialty products » developped and registered by BioAlliance Pharma on several international territories. These two products are dedicated to be licensed to commercial partners to be promoted to specialized targets, thus generating revenues for BioAlliance Pharma. Moreover, Sitavig® is licensed to Daewoong Pharmaceutical Co., Ltd in Korea and EMS in Brazil.

About Innocutis

Innocutis is a pharmaceutical company specializing in the development and commercialization of therapies focused on medical treatment of dermatological conditions, with a portfolio of established branded prescriptions. Innocutis meets growing unmet medical needs is this specialty and with “best-in-class” therapies, provides clinicians with improved solutions for the management of daily challenges experienced in their practice.

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. For more information, visit the website www.bioalliancepharma.com.

The company has recently announced the merger with the Danish company Topotarget to create Onxeo, following approval of shareholders of both companies end of June 2014.

Onxeo aims to become a leading orphan oncology company. With a portfolio of advanced programs targeting severe orphan oncology diseases for which there is an unmet medical need, Onxeo will offer increased market attractiveness and reinforced visibility, notably towards specialized international investors, thanks to a large and advanced product portfolio developed by a skilled team with a demonstrated know-how.

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).

Contacts

BioAlliancePharma SA
Judith Greciet, CEO
judith.greciet@bioalliancepharma.com
Nicolas Fellmann, CFO
nicolas.fellmann@bioalliancepharma.com
Tel.: +33 1 45 58 76 00
or
ALIZE RP
Caroline Carmagnol
+33 6 64 18 99 59
bap@alizerp.com

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Contacts

BioAlliancePharma SA
Judith Greciet, CEO
judith.greciet@bioalliancepharma.com
Nicolas Fellmann, CFO
nicolas.fellmann@bioalliancepharma.com
Tel.: +33 1 45 58 76 00
or
ALIZE RP
Caroline Carmagnol
+33 6 64 18 99 59
bap@alizerp.com