PARIS--(BUSINESS WIRE)--Regulatory News :
BioAlliance Pharma SA (Paris:BIO) (Euronext Paris - BIO), an innovative Company dedicated to the development of orphan oncology products and to supportive care products, today published the major key milestones achieved during the third quarter of 2013.
July was marked by a successful capital increase which enabled the Company to raise a net amount of €8.4 million and showed strong support from its shareholders, specifically the two largest, Financière de la Montagne and IDInvest. This transaction was strongly oversubscribed and has significantly reinforced the cash reserves amounting to €15.1 million as of September 30, 2013.
In parallel, BioAlliance Pharma has achieved major milestones in the development of its two key programs (Orphan Oncology Products portfolio):
- ReLive Phase III trial (Livatag®) evaluating the efficacy of Livatag® in the treatment of primary liver cancer: recruitment is on track and strongly increasing with to date more than 80 patients screened in about 20 sites in France, and confirmation of the product’s good tolerance profile validated by the third Data and Safety Monitoring Board meeting (DSMB, committee of independent experts). The European study’s extension is ongoing in 6 countries (Spain, Italy, Russia, Hungary, Austria and Belgium) and the study should be extended to the US in 2014, enabling the end of recruitment in 2015 with results expected in 2016. This drug represents a key growth potential for the Company.
- Phase II trial with Validive® in the prevention of chemoradiation therapy-induced oral mucositis in patients with head and neck cancer: international expansion of recruitment (Europe, United States) with more than 75% of recruitment completed to date and creation of an international Advisory Board in charge of optimizing the product’s development strategy. The recruitment should be completed beginning of 2014 for results expected in the second part of that year.
BioAlliance Pharma has associated the best worldwide experts in the area to each of its two products, Livatag® and Validive®, to ensure the clinical and regulatory relevance of the Company’s development options in indications where the current lack of available treatment requires new therapeutic approaches.
Furthermore, BPIfrance has recognized the innovation brought by Livatag® with the grant of €9 million in funding to the NICE (Nano Innovation for Cancer) consortium (with €4.3 million directly allocated to BioAlliance as leader of the consortium) whose purpose is to build a pioneer platform dedicated to nanomedicines.
Moreover, BioAlliance Pharma has reinforced the protection of Sitavig® with the grant of two new patents in the United States and in South Korea. The product’s market exclusivity is thus guaranteed until 2029 in major international territories and represents an additional asset to sign an agreement with commercial partners.
At last, outside any new license agreement, the consolidated turnover for the third quarter 2013 stood at €246,000 and amounted to €1.1 million over the first 9 months.
“The third semester of 2013 was devoted to the international expansion of our two clinical trials in an increasing number of leading hospitals”, declared Judith Greciet, CEO of BioAlliance Pharma. “The trial with Validive® is approaching its completion with results expected in 2014, a critical year for the product’s and the Company’s valorization. Our capital increase achieved beginning of the third semester has enabled us to reinforce our cash reserves. Active discussions are ongoing to secure a partnership agreement on Sitavig® which should represent a new source of revenue to face the next steps over the coming months”.
Expected upcoming newsflow:
- US extension of the Phase III Clinical trial ReLive planned H1 2014
- Next DSMB (Data Safety Monitoring Board) scheduled Q2 2014
- End of recruitment of the Phase II clinical trial planned H1 2014 with preliminary results expected H2 2014
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:
Loramyc®/Oravig® (oropharyngeal candidiasis in immunocompromised patients): Registered in 26 countries (EU, US, Korea), commercialized in Europe and in the US.
Sitavig® (Acyclovir Lauriad®) (labialis herpes): Registered in the US and in 8 European countries, registration status in the other European countries.
Fentanyl Lauriad® (chronic cancer pain): Positive preliminary Phase I results
Orphan Oncology products
Livatag® (Doxorubicin Transdrug™) (primary liver cancer): Phase III on going
Validive® (Clonidine Lauriad®) (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 2012 Reference Document filed with the AMF on April 18, 2013, which is available on the AMF website (http://www.amf-france.org) or on BioAlliance Pharma SA's website (http://www.bioalliancepharma.com).