Regulatory News:
BioAlliance Pharma SA (Paris:BIO), an innovative company dedicated to
the development of orphan oncology and to supportive care products,
announces the issuance of two new patents for Sitavig® (acyclovir
mucoadhesive tablet) by the U.S. and South Korean patent offices.
Sitavig® is approved in the U.S. and eight European countries (Sweden,
the U.K., Spain, Italy, Denmark, Finland, Norway and Poland) for the
treatment of recurrent labial herpes in adults.
Sitavig’s patent protection is now further enhanced with:
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The issuance of a third patent family in the U.S. based on the
administration scheme, a single application of Sitavig® that covers
the entire herpes outbreak episode. This new patent extends Sitavig
market exclusivity for two additional years, until December 2029 in
Sitavig’s first commercial market.
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The extension of the second patent family with a new issuance from the
South Korean Patent Office. After Europe, the United States, China and
Japan, the South Korean office has granted the patent based on
Sitavig’s original manufacturing process, which gives the product its
special adhering property.
This set of three patent families and patent applications therefore
reinforces Sitavig’s market protection and gives Sitavig strong
exclusivity until 2029 in key international markets.
"These grants mirror our industrial protection strategy which is to
maximize the value of the products in our pipeline with the best
possible exclusivity. Sitavig®’s extended protection until 2029 in the
U.S. should help facilitate discussions with potential business
partners," said Aude Michel, Director of Business Development
BioAlliance Pharma.
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 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 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 2012 Reference Document filed with the AMF on April 18,
2013, which is available on the AMF website (http://www.amf-france.org)
or on BioAlliance Pharma SA's website (http://www.bioalliancepharma.com).
Copyright Business Wire 2013