Regulatory News :
BioAlliance Pharma SA (BIO.PA) (Euronext Paris – BIO), an innovative
Company dedicated to the development of orphan oncology products, today
published its 2013 financial results, major achievements on its clinical
programs in 2013 and its prospects 2014.
The year 2013 was marked by key milestones achieved in the development
of its two major products, Livatag® and Validive®:
ReLive, Livatag® phase III clinical trial in the treatment of primary
liver cancer, has continued in line with the international expansion
strategy of the study.
Since mid-2013 the trial has been extended
to 7 European countries and is being implemented in the United States,
following the Investigational New Drug (IND) authorization received
from the FDA at the end of 2013. More than 100 patients have been
enrolled and the geographic expansion will support patients’ enrolment
increase. Last patient is scheduled to be enrolled late 2015 with
preliminary results expected in 2016.
Finally, as part of its
bi-annual review, the international Board of independent experts (Data
Safety Monitoring Board) confirmed the product’s good safety profile
twice in 2013.
Validive® phase II clinical trial in the prevention of severe oral
mucositis has been strongly accelerated and nearly 95% of the patients
have already been enrolled to date. The Company expects to complete
patient recruitment in the coming weeks with preliminary results
expected in the second half of 2014.
designation has been granted from US FDA to Validive®, a status
dedicated to treatments addressing very serious diseases, with high
unmet medical needs. This designation will allow for the accelerated
review of clinical data, thereby reducing the time to potential market
authorization by about 3 to 6 months.
Both products, at an advanced stage of their development, target severe
diseases with poor therapeutic alternatives. Positioned in markets of
hundreds of millions Euros, they represent major growth drivers for the
Company in the short and medium term.
For the second time, BioAlliance Pharma has succeeded to register a drug
in the US with NDA granted for Sitavig® in the treatment of recurrent
labial herpes. Advanced discussions regarding partnerships are ongoing
and agreements are expected in the coming months.
Key figures from the consolidated financial statements for the financial
year 2013 are summarized in the table below:
Consolidated income amounted to €1.5 million in 2013 and mainly resulted
from the commercial partners’ activity related to Loramyc®/Oravig®. The
difference as compared to the previous year is due to the recognition in
2012 of non-recurrent payments under license agreements with Therabel
and Vestiq companies for a total amount of €2.5 million. Considering
Oravig®’s sales level, no payment of milestone from American partner
Vestiq is expected in the short term.
Operating expenses amounted to €17 million (+ 8.6% as compared to 2012),
including €10 million expenses for R&D, increased by 26% compared to
2012, excluding regulatory taxes. This significant financial effort has
primarily supported the acceleration and international expansion of
Validive® and Livatag® clinical programs, while also reflecting the
Company’s efforts to control general and administrative expenses.
The consolidated cash position as of December 31, 2013 amounted to €11.3
million, notably following a €8.4 million fund raising realized in July
2013, which was oversubscribed by 155%. Beyond licensing agreements
expected in the coming months, the Company is considering the most
appropriate funding strategy to pursue the dynamic deployment of its
“The Company’s strategy is to become a key player in the orphan
oncology diseases and its growth will be sustained by both its key
products in these pathologies. In 2013, significant progress has been
achieved on these programs, and especially in the United States with the
IND for Livatag® and the Fast track designation for Validive®. Phase II
preliminary results for Validive®, expected in Q4 2014 will represent a
major catalyst of value creation for this asset. Based on our expertise
and supported by the dynamic advancement of our programs, BioAlliance
has everything in place for a strong growth”, comments Judith
Greciet, CEO of BioAlliance Pharma.
BioAlliance will comment on major current issues and its annual
financial statements during its SFAF meeting which will be held on
February 28, 2014 at 9:30am at the Company’s headquarters (49 boulevard
Martial Valin, Paris 15°, France), and during the audio/web conference
the same day at 6:00 pm:
Tel: +33 (0)1 70 77 09 37
/ Meeting nb: 702 301 629 / Password: product
For replay: Nb
+33 (0)1 72 00 15 00 / Conf Nb: 285911#
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.
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
Transdrug™) (primary liver cancer): Phase III on going
(Clonidine Lauriad®) (mucositis): Phase II on going
(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
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).
- Health Care Industry
- Pharmaceuticals & Drug Trials
- Euronext Paris
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BioAlliance Pharma Provides Updates on Its Major Achievements and Reports 2013 Consolidated Financial Results
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