BIOALLIANCE PHARMA : and Teva announce first license agreement for Sitavig® for Israel (PDF - 76 Ko)
06/13/2012| 02:06pm US/Eastern
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Paris, June 13, 2012 - BioAlliance Pharma SA (Euronext Paris
- BIO), a company dedicated to oncology orphan products and
specialty products today announces the signature of an
exclusive license agreement for Sitavig®
(Acyclovir Lauriad™) with Abic Marketing Limited
("Teva"), a group subsidiary of Teva Pharmaceutical
Industries Limited (NASDAQ: TEVA) for
commercialization rights in Israel.
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 based on the
innovative mucoadhesive buccal technology
Lauriad™, delivering very high concentrations of
acyclovir at the site of herpes infection. The phase III
trial (775 patients) has shown a strong efficacy and safety
profile, basis for the registration submission.
Financial terms of this license agreement are not publicly
disclosed. This agreement includes upfront and milestone
payments as well as royalties on sales in Israel, to be paid
to BioAlliance Pharma by Teva.
« This license agreement with Teva is a major step for
Sitavig® as it acknowledges the interest and the
commercial potential of this innovative product", declared
Judith Greciet, CEO of BioAlliance Pharma. "Teva as the
leading player on Israeli market is a key partner for
BioAlliance and for the commercialization of
Sitavig®, and we look forward to build a
constructive and close partnership", added Judith Greciet.
About Sitavig®
BioAlliance Pharma has conceived and developed
Sitavig® for the treatment of recurrent
orofacial herpes in immunocompetent patients. The product is
an innovative mucoadhesive buccal tablet delivering very high
concentrations of the active ingredient in mucosa and lips,
sites of the herpes infection.
The efficacy of Sitavig® has been validated with
a pivotal phase III clinical trial conducted in 775 patients
that showed a significant reduction in the occurrence of
vesicular lesions (p=0.043), in the time to healing of
vesicular lesions (p=0.015), in the herpes episode duration
(p=0.0038) and in the severity of symptoms(p=0.008).
Moreover, a 9-month follow-up showed that
Sitavig® had an effect on the long term,
delaying the time to occurrence of the following herpes
episode (p=0.04).
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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 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
Oncology Orphan 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
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).
BioAlliance Pharma SA
Judith Greciet, CEO Tel +33 1 45 58 76 00
judith.greciet@bioalliancepharma.com Nicolas Fellmann, CFO
Tel.: +33 1 45 58 71 nicolas.fellmann@bioalliancepharma.com
ALIZE RP Caroline Carmagnol Tel.: +33 6 64 18 99 59
caroline@alizerp.com
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