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Biotest AG Landsteinerstr. 5 63303 Dreieich, Germany http://biotest.de
Contact Ms Dr. Monika Buttkereit +49 6103 8014406
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Biotest AG

Biotest AG und ADMA Biologics, Inc. führen Kooperation bei RSV-Hyperimmunglobulin RI-002 fort

Zulassungsantrag nach erfolgreicher Phase III Studie bei amerikanischer Zulassungsbehörde eingereicht

(PresseBox) (Dreieich, )
Im Rahmen des Lizenzvertrags vom 31. Dezember 2012 hat Biotest eine Meilensteinzahlung geleistet, die nach der Einreichung der Biologics License Application (BLA) (Zulassungsantrag) bei der US-Zulassungsbehörde FDA (U.S. Food and Drug Administration) für das Entwicklungsprodukt RI-002 durch ADMA Biologics, Inc., New Jersey, USA, (ADMA) fällig wurde. RI-002 ist ein Hyperimmunglobulin aus humanem Plasma mit natürlich vorkommenden Antikörpern gegen das Respiratorische Synzytial-Virus (RSV).

Biotest hat von ADMA die Vertriebslizenz für Europa und andere ausgewählte internationale Märkte erworben. Zusätzlich zu den Vertriebsrechten wurde noch ein weiterer Vertrag zwischen unserer Tochtergesellschaft Biotest Pharmaceuticals Corp, USA, und ADMA abgeschlossen, der Plasmalieferungen und Dienstleistungen im Oksxsdc Cvnxbnmsph dwdfwudp.

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