PARIS, Jul 02, 2012 (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(R) 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(R) 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(R), miconazole Lauriad(TM) 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(R) in healthy Japanese adults. In addition to confirming the good tolerance of Loramyc(R), 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(R) 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(R) 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(R) in Japan, as planned in its objectives".
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 products Loramyc(R)/Oravig(R) (oropharyngeal candidiasis in immunocompromised patients): Registered in 28 countries (EU, US, Korea) Sitavir(R)/Sitavig(R) (Acyclovir Lauriad(TM)) (labialis herpes): Positive phase III final results; registration status Fentanyl Lauriad(TM) (chronic cancer pain): Positive preliminary Phase I results
Orphan Oncology products Livatag(R) (Doxorubicin Transdrug(TM)) in primary liver cancer: Phase III on going Validive(TM) (Clonidine Lauriad(TM)) in mucositis: Phase II on going AMEP(R) (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 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 ).
SOURCE: BioAlliance Pharma SA
BioAlliance Pharma SA
Judith Greciet, CEO
Tel: +33 1 45 58 76 00
Nicolas Fellmann, CFO
Tel.: +33 1 45 58 71 00
Tel.: +33 6 64 18 99 59