Source : BusinessWire

BioAlliance Pharma Accelerates Its International Clinical Research Program

Le 28/11/2007

Regulatory News:


BioAlliance Pharma SA (Paris:BIO) today announced it has extended
its ongoing acyclovir Lauriad(R) Phase III trial in the treatment of
oral herpes to the United States. Ten clinical centers have been
opened in the country and will join the forty or so in Australia and
Europe already participating in the trial, with a target of 640
patients.


The technology used in the trial (the Lauriad(R) buccal
muco-adhesive tablet) has already proved itself in the company's
Loramyc(R) product. The healing time of herpes lesions after taking a
single acyclovir Lauriad(R) tablet will be compared with placebo. The
company is planning to submit market authorization applications in the
first half of 2009 in Europe and in the United States, subject to
additional regulatory requirements.


Furthermore, after successful completion of patient enrolment in
the pivotal phase III clinical trial performed with a view to
registering Loramyc(R) in the US, the company is continuing to open
additional European centers for its phase III doxorubicin Transdrug(R)
trial in primary liver cancer.


"This successful international extension of our trials confirms
the quality of BioAlliance Pharma's Clinical Research and Regulatory
Affairs teams", commented Dominique Costantini, President of the
Management Board. "With Acyclovir Lauriad(R) in the USA, our objective
is to be able to access 60% of the potential market that the product
represents".


About BioAlliance Pharma


BioAlliance Pharma SA is a specialty pharmaceutical company
focused on the treatment of opportunistic infections in cancer and
HIV. The company develops and commercializes innovative products which
address resistance issues. The company has launched its first
portfolio product (Loramyc(R)) in France, which is currently in Phase
III clinical development in oropharyngeal candidiasis in the USA. In
addition, two other innovative products are currently in phase III
clinical trials: acyclovir Lauriad(R) in oral herpes (based on the
same Lauriad(R) muco-adhesive technology as Loramyc(R), which enables
targeted release at the disease site) and doxorubicin Transdrug(R) in
primary liver cancer (based on the Transdrug(R) nanoparticle
technology, designed specifically for intracellular targeting of
resistant cells). The company is also developing a new therapeutic
entities program focused on the oncology and HIV markets.


In 2007, the company has established strategic alliances for
commercializing Loramyc(R) in Europe (with JV SpeBio) and the USA
(with Par Pharmaceutical). For more information, visit
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 reference document approved by
the AMF on April 6th 2007 under the number R. 07-031, which is
available on the AMF website (http://www.amf-france.org) or on
BioAlliance Pharma S.A.'s website (http://www.bioalliancepharma.com).


Contact :

BioAlliance Pharma SA
Dominique Costantini, +33 1 45 58 76 01
President and CEO
dominique.costantini@bioalliancepharma.com
or
Nicolas Fellmann, Tel.: +33 1 45 58 71 00
CFO
nicolas.fellmann@bioalliancepharma.com
or
ALIZE RP
Caroline Carmagnol, +33 6 64 18 99 59
caroline@alizerp.com

Plus d'infos sur BioAlliance Pharma