Regulatory News:
BioAlliance Pharma SA (Euronext Paris - BIO) (Paris:BIO), an
innovative Company dedicated to the development of orphan oncology
products and to supportive care products, today publishes its
consolidated half-year accounts as of June 30, 2012, and the major
key milestones recently achieved.
During this semester, BioAlliance Pharma has actively conducted
the development programs of its high potential « Orphan
Oncology Products » portfolio and has achieved the key
milestones as they were planned.
- The Phase III clinical study with
Livatag® (ReLive) in the primary liver cancer was implemented and
effectively initiated in France in June 2012. Since then, about 10
patients have been recruited in the study. The assessment of the
first 25 patients included by the international independent
Monitoring Board should be conducted at the end of the year or at
the beginning of next year, as scheduled.
- An expansion to 4 additional new
European countries is ongoing for the phase II clinical trial with
Validive™, developed in the treatment of severe radio- and
chemotherapy induced mucositis in patients with head and neck
cancer. The initiation of new sites should help accelerate patient
recruitment in this study in which more than 35% of patients have
already been included, thus making it possible to anticipate the
end of recruitment for the second semester of 2013.
- The application for a phase I/II
clinical trial with the AMEP® biotherapy in the metastatic melanoma
received the approval from the French drug agency (Agence Nationale
de Sécurité du Médicament) in June 2012. The product has also
obtained the grant of two patents reinforcing its US industrial
property.
Moreover, the Company is conducting a registration procedure at
the same time in Europe and in the United-States for its specialty
product Sitavig®. The receivability of the US registration dossier
for substantial evaluation by the FDA was obtained in May 2012,
whereas a first international license agreement was signed in June
2012 with TEVA for Israel.
Finally, at the beginning of the second semester, BioAlliance
Pharma has announced the signature of a license agreement term
sheet with the Company Vestiq for the commercialization of Oravig®
in the United-States for a global amount up to $44 million. Its
launch, expected in a few months in the world’s largest market,
will complete the commercialization that has already begun in
Europe.
« This year’s challenges will focus on the progress of
programs creating considerable value for our company, and the
achieved steps in the first semester that are putting us in a very
positive perspective of evolution for the future », says
Judith Greciet, the company’s CEO.
“Our commitments regarding the implementation of the Livatag®
study that was highly expected by the medical and financial
community have been met, and the already active recruitment on this
study shows the expectation of investigating doctors for our
product. The implementation of elements to take up the
commercialization of Oravig® in the United-States as well as the
admissibility of the Sitavig® file by the FDA were key factors for
us this year. Our teams have once again shown their mobilization
capacity and their know-how in these domains ».
« In terms of results, we mastered our operating conditions
throughout the first semester by reducing our operating costs by
almost 13% whereas at the same time our R&D investments were
reinforced to accelerate our programs » comments Nicolas Fellman,
CFO of BioAlliance Pharma. « This is thanks to a healthy
budget of €20.4 million at 30 June 2012 ».
Analysis of
the H1 2012 accounts
Consolidated accounts (IFRS-compliant)
In thousands euros
30/06/2012
(6 months)
30/06/2011
(6 months)
Recurring revenues from license
agreements
393
1.019
Non recurring revenues from license
agreements
418
151
Other revenues*
30
10
Operating expenses
(8.705)
(9.936)
R&D investments
(4.849)
(4.017)
Operating profit/loss (7 864) (8 757) Net profit/loss (7 834) (8
750)
* Mostly direct sales in France in 2011
The recurring revenues are generated by sales and royalties on
sales linked to the Company’s license agreements whereas the non
recurring revenues from the license agreements include a share from
staggered upfront payments received from these agreements.
Operating expenses amounted to €8.7 million over the semester,
decreasing by 13% as compared with 2011. This trend is notable
while the Company has strengthened its R&D investments to
sustain the progress of its programs with an international Clinical
Research Organization (CRO) to implement and follow-up Validive™
and ReLive clinical studies and the production of clinical batches
for the ReLive (Livatag®) study, and taxes linked to the Sitavig®
registration dossier by the FDA.
The net income as of June 30, 2012 totaled -7.8 million Euros,
improving as compared with -8.8 million Euros in 2011.
Cash reserves at the end of June 2012 amounted to €20.4 million,
compared with €28.6 million as of December 31, 2011.
Analyst meeting and
audio/web-conference call (in English)
BioAlliance Pharma will hold a meeting at 8:45 am on Friday
September 14, 2012, at its corporate headquarters (49 boulevard
Martial Valin, Paris, France). An audio/web-conference in English
will be organized at 11:30 am Paris time (GMT+1). Access numbers
and codes are given below.
----------
1) Audio connexion from France or abroad :
+33 (0)1 70 77 09 34
2) Webconference connexion :
https://bioalliancepharma-en.webex.com/bioalliancepharma-en/j.php?ED=223577562&UID=0&PW=NMmRiNmU1N2Mx&RT=MiMyMw%3D%3D
3) Meeting Number: 709 706 290Meeting
Password: BioAlliance
For Conference call replay : +33(0)1 72 00
15 00 (in English)
Conference reference : 278087#
----------
BioAlliance Pharma today announced the filing of its financial
report for the half-year ended June 30, 2012. The half-year
financial report, including the consolidated accounts as of June
30, 2012, can be viewed in the “Investor” section of the Company’s
website (http://www.bioalliancepharma.com).
The half-year accounts have been verified by the statutory
auditors and approved by the Board of Directors on September 13,
2012.
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:
Specialty productsLoramyc®/Oravig® (oropharyngeal
candidiasis in immunocompromised patients): Registered in 28
countries (EU, US, Korea)Sitavir®/Sitavig® (Acyclovir LauriadTM)
(labialis herpes): Positive phase III final results; registration
statusFentanyl LauriadTM (chronic cancer pain): Positive
preliminary Phase I results
Oncology Orphan productsLivatag® (Doxorubicin Transdrug™)
(primary liver cancer): Phase III on goingValidive® (Clonidine
LauriadTM) (mucositis): Phase II on goingAMEP® (invasive melanoma):
Phase I on going
For more information, visit the BioAlliance Pharma web site at
www.bioalliancepharma.com
DisclaimerThis 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 2011 Reference Document filed
with the AMF on April 24, 2012, which is available on the AMF
website (http://www.amf-france.org) or on BioAlliance Pharma SA's
website (http://www.bioalliancepharma.com).
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