BioAlliance Pharma SA (Euronext Paris - BIO) (Paris:BIO), an innovative Company dedicated to the development of orphan oncology products and to supportive care products, announces the approval of Sitavig® (acyclovir LauriadTM) for the treatment of recurrent labial herpes in 8 European countries*.
The decentralized procedure, with Sweden as Reference Member State, ended with a positive opinion for these first 8 countries. Each country will now issue a national marketing authorization in the coming weeks.
Besides, BioAlliance Pharma plans to pursue the submission of the registration dossier in other European countries as soon as the first quarter of 2013. The evaluation by the Agencies should then last 4 to 6 months.
« This approval in an initial wave of European countries is the first registration of Sitavig® which should be followed in the next few months by its registration in the US and in additional European countries”, declares Pierre Attali, COO of BioAlliance Pharma. “This is the second product coming from the BioAlliance’s research to obtain a European registration, which demonstrates the performance and the skills of the Company”.
BioAlliance Pharma has conceived and developed Sitavig® for the treatment of recurrent labial herpes in immunocompetent patients presenting more than 4 episodes a year. Sitavig® is an innovative mucoadhesive buccal tablet delivering very high concentrations of acyclovir at the site of the herpes infection. Sitavig® combines an established efficacy and a good safety profile. Labial herpes is an infection affecting about 100 millions of patients worldwide of whom more than a third suffers from recurrent herpes (4 or more episodes per year).
* Sweden, United Kingdom, Spain, Italy, Denmark, Finland, Norway
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:
Loramyc®/Oravig® (oropharyngeal candidiasis in immunocompromised patients): Registered in 28 countries (EU, US, Korea)
Sitavir®/Sitavig® (Acyclovir LauriadTM) (labialis herpes): Positive phase III final results; registration status
Fentanyl LauriadTM (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
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).
Judith Greciet, +33 1 45 58 76 00
Nicolas Fellmann, +33 1 45 58 71
Caroline Carmagnol, +33 6 64 18 99 59
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