Regulatory News:
BioAlliance Pharma SA (Paris:BIO) (Euronext Paris - BIO), a company
dedicated to specialty and orphan oncology products, today announces its
2011 achievements and 2012 prospects.
The year 2011 was marked by major achievements of its key assets and
by determining strategic orientations that enable BioAlliance Pharma
to enter 2012 with strong growth prospects on its two product portfolios.
Orphan oncology product portfolio:
-
Based on significant preliminary survival results of a phase II
clinical trial showing a survival increase (17 months additional
survival versus comparative group) and on a new infusion scheme aiming
to manage the respiratory severe adverse effects occurred in this
trial, leader of the orphan product portfolio, Livatag® has
obtained the green light by the end of 2011 for a phase III trial in
the primary liver cancer. This international clinical trial should
start in 2012.
-
The phase II clinical trial with Clonidine Lauriad™ in the
prevention of radiotherapy-induced oral mucositis is ongoing in
patients with head and neck cancer. Thanks to the international
extension of its recruitment in 2011, the number of active centers
should be increased to about 40 in 2012, thus optimizing the
recruitment rate. Moreover, Clonidine Lauriad™ has been granted
the orphan designation in Europe in 2011.
-
After completion of the phase I clinical trial via local
administration (intratumoral) with the AMEP™ biotherapy, a
phase I/II trial via intramuscular administration (systemic) has been
submitted beginning of 2012 to start this same year. This
innovative treatment, co-financed by OSEO's Strategic Industrial
Innovation Program, targets a very aggressive disease, the metastatic
melanoma.
Specialty product portfolio:
-
The European registration application for Sitavir®
(treatment
for recurrent orofacial herpes) has been submitted by the end of 2011
and BioAlliance Pharma is planning to submit its application to the
FDA (Food and Drug Administration) during the first quarter 2012.
Second product successfully developed by the BioAlliance’s teams,
Sitavir® is becoming the suitable candidate to
international partnership agreements able to generate significant
financial resources to the Company.
-
At last, Loramyc® is pursuing its European development,
notably with its launch in Italy expected in 2012. Discussions on a
partnership in the United-States are ongoing.
With the successful capital increase implemented in August 2011, the
Company’s cash reserves stood at €28.7 million at the end of 2011
and its 2011 consolidated turnover amounted to €3.2 million. This cash
level, which should be reinforced by short- or mid-term license
agreements, enables BioAlliance Pharma to ensure an optimal financing of
its key programs.
« Our « Orphan oncology products » portfolio represents a major lever
for business growth. It includes products like Livatag®,
the market potential of which has been estimated at over €800 million.
The milestones that we have reached to date demonstrate our know-how in
drug development. BioAlliance has the assets to reinforce its growth
dynamics while delivering innovations in fields with unmet needs and
thus creating value for its shareholders”, commented Judith Greciet,
CEO of 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; the products’ commercialization rights are licensed
to international commercial partners invested in the hospital setting.
In areas where medical needs are insufficiently met, its targeted
approaches help overcome drug resistance and improve patient health &
quality of life.
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® (Acyclovir LauriadTM) (labialis herpes):
Positive phase III final results; registration status
Fentanyl LauriadTM (chronic cancer pain): Positive
preliminary Phase I results
Orphan Oncology products
Livatag® (Doxorubicin Transdrug™) in primary) liver cancer:
Authorization for Phase III clinical trial
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 2010 Reference Document filed with the AMF on April 7,
2011, which is available on the AMF website (http://www.amf-france.org)
or on BioAlliance Pharma SA's website (http://www.bioalliancepharma.com).
