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BioAlliance Pharma SA (Paris: BIO) today announces, following the end of the European Mutual Recognition Procedure last December (with France as Reference Member State) that it has just received the Marketing Authorisation for Loramyc® in the UK and Denmark.
The grant of the Marketing Authorisation in the UK represents an important milestone for BioAlliance Pharma especially with the payment of €2.5 million by its partner SpePharm, according to the terms of the agreement signed in March 2007, which led to the creation of the SpeBio JV for the distribution of Loramyc® in Europe.
"We are delighted of this European success which confirms the quality and the efficiency of our development and regulatory teams and experts. Currently being launched in France, Loramyc® will be present on the European market in 2008 as planned. The other main European countries should grant their Marketing Authorisation for Loramyc® in the very near future", stated Dominique Costantini Chief Executive Officer.
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. The company has launched its first portfolio product (Loramyc®) in France and the compound 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).
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 ).
For press releases and other company information, visit www.bioalliancepharma.com.
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BioAlliance Pharma SA
+33 1 45 58 76 01
President and CEO
+33 6 64 18 99 59
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