BioAlliance Pharma SA (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.