PARIS--(BUSINESS WIRE)--Regulatory News:
BioAlliance Pharma SA (Paris:BIO) (Euronext Paris - BIO), an innovative Company specialized in the development of drugs in orphan oncology diseases, today published a summary of the key events of the first quarter of 2014, as well as its consolidated revenues for the quarter.
Key orphan oncology programs Validive® and Livatag® have successfully reached important milestones during the first quarter of 2014, resulting from the progress of R&D operations for these high-potential products:
Validive®, currently in a Phase II trial in the prevention of
chemo/radiation therapy-induced severe oral mucositis in patients with
head and neck cancer:
- Fast track designation granted by the US FDA, allowing for the accelerated review of clinical data and confirming mucositis as a very serious condition with high unmet medical needs.
- Signature of a manufacturing agreement with UK specialist Penn Pharma in view of the production of clinical batches for the phase III as well as commercial batches.
Enrollment in the large and robust phase II randomized double blind trial will be completed shortly thus preliminary results should be published according to expected timeline ie Q4 2014. This significant development step will be a major trigger in the value creation of the company.
Livatag®, currently in a Phase III trial (ReLive) assessing the
efficacy of Livatag® in the treatment of primary liver cancer:
- ReLive now opened in 8 European countries and US, enrollment up and running with more than 25% achieved, on track with study planning.
- New patent issued by the European Patent significantly extending Livatag® protection until 2032.
- Mid-April, renewed unanimous recommendation from the Data Safety and Monitoring Board to continue the ReLive study without modification, confirming the good safety profile of the product.
Concerning Sitavig® (recurrent labial herpes), licensing agreements have been signed with key partners, Innocutis Holding in the US specialized in dermatology and that will promote Sitavig® to key prescribers as soon as Q3 2014 and Daewoong Pharmaceutical in South Korea in charge of registration and commercialization of the product.
Consolidated revenues for the first quarter 2014 amounted to 0.4 million Euros, in line with previous quarters, and the consolidated cash balance amounted to 7.7 million Euros as of March 31, 2014.
“BioAlliance has achieved critical steps of its growth strategy, driven by the acceleration of our key programs, Livatag® and Validive® which are now heading to significant value creating milestones in the near term. These assets and our proven track record in terms of development will be leveraged by our proposed merger with Topotarget. This transaction will create a major player in Orphan Oncology, a high value market, with an enlarged promising pipeline, reinforced expertise, financial complementarities and increased attractiveness towards specialized international investors”, declares Judith Greciet, CEO of BioAlliance Pharma.
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.
BioAlliance Pharma has developed an advanced product portfolio:
Orphan Oncology products
Livatag® (Doxorubicin Transdrug™) (primary liver cancer): Phase III on going
Validive® (Clonidine Lauriad®) (mucositis): Phase II on going
AMEP® /Synfoldine (invasive melanoma):
BioAlliance Pharma has announced a merger project with the Danish listed company Topotarget on April 16th 2014.
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 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).