BioAlliance Pharma SA: Quarterly information as of September 30, 2012
November 14 2012 - 11:10AM
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 publishes the major
key milestones achieved during the third quarter of 2012.
Two key achievements will reinforce the Company’s capacity to
create value:
- The effective start of the Phase III
trial with Livatag® in primary liver cancer: at the end of October,
recruitment was in line with the planned schedule and ten patients
have already been treated. The study, opened in twenty sites in
France, should be extended to other European countries in the next
weeks.
- The signature, at the end of September,
of an exclusive license agreement with Vestiq Pharmaceuticals to
commercialize Oravig® (Loramyc® in Europe) in the United-States,
the first worldwide market for this product. With the first supply
of product planned for mid-November, our new partner will be able
to start promoting Oravig® as soon as late 2012. Under this
agreement, an amount of $9 million, royalties excluded, should be
paid over the next two years.
In parallel, BioAlliance Pharma has pursued the registration
procedure of Sitavig® in the US and in Europe for the treatment of
recurrent labial herpes, as well as the recruitment of patients in
its Phase II clinical trial with Validive® in the radio or
chemotherapy-induced oral mucositis in patients with head and neck
cancer. The Company has also obtained the regulatory authorizations
to start its Phase I/II trial with Amep® in the metastatic
melanoma.
“Loramyc®/Oravig® was meant to bring cash reserves on the short
term through agreements with international partners,” reminds
Judith Greciet, CEO of BioAlliance Pharma. “This has been achieved
as more than €53 million have already been received by BioAlliance
over five years, to which should be added amounts to be paid by
Vestiq and others from expected agreements in emerging countries.
As regards operations, we have been reinforcing for several months
our focus on our Orphan Oncology portfolio, our strategic and
growth driving portfolio with Livatag® ranking first.”
While awaiting the commercialization of Oravig® in the
United-States, the turnover for Q3 2012 amounted to €279,000,
representing the royalties on Loramyc® sales in Europe by our
partner Therabel, as well as the staggering of the payments
received under the Asian license agreements.
The consolidated cash reserves stood at €17.3 million as of
September 30, 2012, enabling BioAlliance Pharma to pursue as
planned its ongoing development activities. Non conditional
payments expected from our partners Therabel and Vestiq should
reinforce the Company’s resources within the next months.
* * *
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
Orphan Oncology 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
Disclaimer
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 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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