BioAlliance Pharma announces the grant of US patent covering Sitavig®
July 26 2012 - 12:37PM
Business Wire
Regulatory News:
BioAlliance Pharma SA (Euronext Paris - BIO), an innovative
Company dedicated to the development of orphan oncology products
and to supportive care products, announces the grant of a US patent
protecting its product Sitavig®. This patent covers the Sitavig®
tablet, its manufacturing process and its application for the
treatment of recurrent labial herpes until 2027.
BioAlliance Pharma has conceived and developed Sitavig®
(mucoadhesive tablet containing acyclovir) for the treatment of
labial herpes in immunocompetent patients presenting more than 4
episodes a year. Sitavig® is an innovative mucoadhesive tablet to
apply to the upper gum, allowing the delivery of very high
concentrations of the active ingredient at the site of herpes
infection, thus with a reinforced profile of efficacy.
“After the grant of a patent for Sitavig® in Europe and in major
Asian territories, this US grant gives BioAlliance a worldwide
protection for its product”, declares Aude Michel, Vice President,
Licensing and Legal Affairs, and European Patent Attorney of
BioAlliance Pharma.
“We have obtained the receivability of Sitavig® US registration
file last May from the FDA (Food and Drug Administration). This
strong US patent protection allows its commercialization in the
best conditions, reinforcing the value of this asset”, added Judith
Greciet, CEO of BioAlliance Pharma. “After a first license
agreement with Teva for Israel and with a sales potential from $120
to $150 million, this product is becoming a suitable candidate to a
license agreement, particularly in the United States”.
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 productsLoramyc®/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
statusFentanyl Lauriad™ (chronic cancer pain): Positive preliminary
Phase I results
Oncology Orphan productsLivatag® (Doxorubicin Transdrug™)
(primary liver cancer): Phase III on goingValidive® (Clonidine
Lauriad™) (mucositis): Phase II on goingAMEP® (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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