BioAlliance Pharma Announces the Launch of Sitavig® in the United States by Its Partner Innocutis
July 21 2014 - 2:00PM
Business Wire
And the granting of a new U.S. Sitavig®
patent
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).
BioAlliancePharma SAJudith Greciet,
CEOjudith.greciet@bioalliancepharma.comNicolas Fellmann,
CFOnicolas.fellmann@bioalliancepharma.comTel.: +33 1 45 58 76
00orALIZE RPCaroline Carmagnol+33 6 64 18 99
59bap@alizerp.com
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