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BioAlliance Pharma SA (Paris:BIO), today announced that it had successfully completed patient enrolment in the pivotal phase III clinical trial performed with a view to registering Loramyc® in the US, for the treatment of oropharyngeal candidiasis. With 540 patients enrolled by 40 specialist clinical centers in the USA, Canada and South Africa, the company has achieved its target ahead of schedule. The trial results are expected in the first half of 2008. The company plans to file a market authorization application in the second half of next year, subject to the FDA's regulatory requirements.
"Our development team has proved its effectiveness in successfully completing the enrolment process", commented Dominique Costantini, BioAlliance Pharma's President and CEO. "This milestone is a significant one in our alliance with Par Pharmaceutical, which will commercialize our product in the US - the world's leading market for oropharyngeal candidiasis treatments," she added.
About BioAlliance Pharma SA
BioAlliance Pharma SA is a specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and HIV. The company develops and commercializes innovative products which address resistance issues and has launched its first portfolio product (Loramyc®) in France. Three innovative products are currently in phase III clinical development: two based on the Lauriad® muco-adhesive technology, which enables targeted release at the disease site (Loramyc® in oropharyngeal candidiasis in the USA and acyclovir Lauriad® in oral herpes), and a third based on the Transdrug® nanoparticle technology, designed specifically for intracellular targeting of resistant cells (doxorubicin Transdrug® in primary liver cancer). The company is also developing a new therapeutic entities program focused on the oncology and HIV markets.
This year, the company has established strategic alliances for commercializing Loramyc® in Europe and the USA.
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 reference document approved by the AMF on April 6th 2007 under the number R. 07-031, which is available on the AMF website ( http://www.amf-france.org ) or on BioAlliance Pharma S.A.'s website ( http://www.bioalliancepharma.com ).
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BioAlliance Pharma SA
President and CEO
Tel.: +33 1 45 58 76 01
Tel.: +33 1 45 58 71 00
Tel.: +33 6 64 18 99 59
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