PARIS--(BUSINESS WIRE)-- 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:
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
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).
BioAlliance Pharma SA
Judith Greciet, CEO
Tel +33 1 45 58 76 00
Nicolas Fellmann, CFO
Tel.: +33 1 45 58 71
Tel.: +33 6 64 18 99 59
KEYWORDS: Europe France
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Oncology Pharmaceutical