BioAlliance Pharma SA (Paris:BIO) today announced that it has received three additional Marketing Authorizations under the European Mutual Recognition Procedure for Loramyc(R) 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(R) via the dedicated SpeBio(R) subsidiary (a JV with SpePharm). Under the terms of the current licensing agreement, this marketing authorization will earn BioAlliance Pharma a EUR 2 million milestone payment from SpePharm. Milestone payments linked to marketing approval in Germany and the United Kingdom now amount to a total of EUR 4.5 million and will be fully counted in the turnover of Q1 2008. The terms of the agreement include up to EUR 17 million in sales-linked performance milestone payments.
"These new Marketing Authorizations mean that the internationalization of Loramyc(R) 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.
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