Transgene to Receive First Milestone Payment from Roche Following FDA and EMEA Review of TG 4001 (R3484) Phase III Studies Plan
Transgene S.A. announced that the U.S. food and Drug Administration (FDA) and the European Medicines Agency (EMEA) have reviewed the proposed plan to initiate phase III studies of TG 4001 / R3484 (MVA-HPV-IL2) for the treatment of high grade cervical intraepithelial neoplasia (CIN 2/3). A EUR 10 million payment associated with this milestone should be received by Transgene from Roche before the end of June 2007. Under the collaboration agreement between Roche and Transgene, Roche is responsible for the ongoing development and commercialization of TG 4001 / R3484.
On April 11th, 2007, Transgene and Roche entered into an exclusive worldwide collaboration agreement to develop and commercialize products from Transgene's therapeutic vaccine program against Human Papilloma Virus-mediated diseases. The agreement has become effective as from May 23rd, 2007. In addition to a EUR 13 million upfront payment and the EUR 10 million near-term regulatory milestone payment related to planning the Phase III studies, Roche may pay Transgene up to a total of EUR 195 million, upon the achievement of certain further development and sales-based events in various HPV-related indications. In addition, Transgene is entitled to double-digit escalating royalties on sales once a product is marketed.
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