BioAlliance Pharma: Progress in the development of Loramyc® in Japan towards its registration by the partner Sosei
July 02 2012 - 12:37PM
Business Wire
Regulatory News:
BioAlliance Pharma SA (Euronext Paris - BIO), an innovation
Company dedicated to the development of orphan oncology products
and specialty products, has announced today the completion of phase
I clinical study with Loramyc® in Japan by its partner Sosei Co.,
Ltd, in accordance with the development plan established to
register the product in this country.
In May 2011, BioAlliance Pharma licensed its product Loramyc® to
Sosei Co. Ltd. (a fully owned subsidiary of Sosei Group
Corporation) for a global amount of $18.5 million before royalties,
as well as handing over the management for the product development
and its registration in Japan. Loramyc®, miconazole Lauriad™
muco-adhesive buccal tablet, is indicated in Europe and in the
United States for the treatment of oropharyngeal candidiasis in
immunocompromised patients. The phase I clinical trial, first step
of the development in Japan, was designed to evaluate the
pharmacokinetics and safety of Loramyc® in healthy Japanese adults.
In addition to confirming the good tolerance of Loramyc®, the
collected data have also shown an expected consistency with the
patients’ profile from previous studies.
This phase I trial completed within the planned timelines, thus
confirms that the European and US clinical trial results can be
used for the following steps of the development and the
registration of Loramyc® in Japan, which should now be discussed
with the Japanese drug agency.
“Almost a year after the signature of our partnership agreement
with Sosei for the commercialization of Loramyc® in Japan, the
development program of the product is progressing as planned. Our
partner has already successfully reached a key step towards the
registration of an innovative product on his territory, which will
represent an important innovation compared to the available
treatments for oropharyngeal candidiasis, by enhancing patients’
compliance and improving their quality of life”, declares Judith
Greciet, CEO of BioAlliance Pharma. “After Europe and the United
States, BioAlliance Pharma is pursuing the international
development of Loramyc® in Japan, as planned in its
objectives”.
About Sosei
Sosei is an international biopharmaceutical company anchored in
Japan with a global reach. It practises a reduced risk business
model by acquiring compounds from, and bringing compounds into,
Japan through exploitation of its unique position within global
markets.
For further information about Sosei, please visit
www.sosei.com.
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 Lauriad™)
(labialis herpes): Positive phase III final results; registration
statusFentanyl Lauriad™ (chronic cancer pain): Positive preliminary
Phase I results
Orphan Oncology productsLivatag® (Doxorubicin Transdrug™)
in primary liver cancer: Phase III on goingValidive™ (Clonidine
Lauriad™) in 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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