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BioAlliance Pharma Accelerates Its International Clinical Research Program

Posted on: Wednesday, 28 November 2007, 03:00 CST

Regulatory News:

BioAlliance Pharma SA (Paris:BIO) today announced it has extended its ongoing acyclovir Lauriad® Phase III trial in the treatment of oral herpes to the United States. Ten clinical centers have been opened in the country and will join the forty or so in Australia and Europe already participating in the trial, with a target of 640 patients.

The technology used in the trial (the Lauriad® buccal muco-adhesive tablet) has already proved itself in the company's Loramyc® product. The healing time of herpes lesions after taking a single acyclovir Lauriad® tablet will be compared with placebo. The company is planning to submit market authorization applications in the first half of 2009 in Europe and in the United States, subject to additional regulatory requirements.

Furthermore, after successful completion of patient enrolment in the pivotal phase III clinical trial performed with a view to registering Loramyc® in the US, the company is continuing to open additional European centers for its phase III doxorubicin Transdrug® trial in primary liver cancer.

"This successful international extension of our trials confirms the quality of BioAlliance Pharma's Clinical Research and Regulatory Affairs teams", commented Dominique Costantini, President of the Management Board. "With Acyclovir Lauriad® in the USA, our objective is to be able to access 60% of the potential market that the product represents".

About BioAlliance Pharma

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. The company has launched its first portfolio product (Loramyc®) in France, which is currently in Phase III clinical development in oropharyngeal candidiasis in the USA. In addition, two other innovative products are currently in phase III clinical trials: acyclovir Lauriad® in oral herpes (based on the same Lauriad® muco-adhesive technology as Loramyc®, which enables targeted release at the disease site) and doxorubicin Transdrug® in primary liver cancer (based on the Transdrug® nanoparticle technology, designed specifically for intracellular targeting of resistant cells). The company is also developing a new therapeutic entities program focused on the oncology and HIV markets.

In 2007, the company has established strategic alliances for commercializing Loramyc® in Europe (with JV SpeBio) and the USA (with Par Pharmaceutical). For more information, visit 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 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).

Source: Business Wire

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