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news.Transgene said that the FDA and the European Medicines Agency have reviewed the proposed plan to initiate phase III studies of its investigational drug, which should trigger a E10 million milestone payment from Roche.
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The therapy, currently called TG 4001 / R3484 (MVA-HPV-IL2), has been developed for the treatment of high grade cervical intraepithelial neoplasia, which is the abnormal growth of cells that can lead to cancer.
Under the collaboration agreement between Roche and biopharmaceutical company Transgene, Roche is responsible for the ongoing development and commercialization of TG 4001 / R3484. Transgene is expecting the milestone payment from Roche before the end of June 2007.
In addition to this payment, Roche may pay Transgene up to a total of E195 million, upon the achievement of certain further development and sales-based events in various HPV-related indications. In addition, France-based Transgene is entitled to double-digit escalating royalties on sales once a product is marketed.