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Biopharmaceuticals Regulatory

 News Release - March 26, 2008

BioAlliance Pharma Receives Market Approval for Loramyc(R) in Germany, Belgium and Luxemburg

PARIS--(HSMN NewsFeed)--Regulatory News: BioAlliance Pharma SA (Paris:BIO ) today announced that it has received three additional Marketing Authorizations under the European Mutual Recognition Procedure for Loramyc® in Germany, Belgium and Luxemburg (following on from the first authorizations granted in January in the United Kingdom and Denmark).

Market approval in Germany is another important milestone for BioAlliance Pharma in its Europe-wide commercialization strategy for Loramyc® via the dedicated SpeBio® subsidiary (a JV with SpePharm). Under the terms of the current licensing agreement, this marketing authorization will earn BioAlliance Pharma a €2 million milestone payment from SpePharm. Milestone payments linked to marketing approval in Germany and the United Kingdom now amount to a total of €4.5 million and will be fully counted in the turnover of Q1 2008. The terms of the agreement include up to €17 million in sales-linked performance milestone payments.

"These new Marketing Authorizations mean that the internationalization of Loramyc® is continuing actively within Europe. We are working closely with the regulatory agencies in the remaining countries (Italy, Spain, Ireland, Sweden, Norway, Finland and The Netherlands), which should grant their approval in the very near future. The product availability for patients will depend on price negotiation and reimbursement constraints in each country but are scheduled for 2008 in the United Kingdom and Germany, in particular", commented Dominique Costantini, President and CEO.

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 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 infectious disease 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 BioAlliance Pharma's website at


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 6 2007 under the number R. 07-031, which is available on the AMF website ( or on BioAlliance Pharma S.A.'s website (

Source: BioAlliance Pharma

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