Roche and Transgene entered into an exclusive, worldwide collaboration agreement to develop and commercialize products from Transgene's therapeutic vaccine program against HPV-mediated diseases.
The agreement includes Transgene's lead candidate, TG 4001, for the treat ment of high-grade cervical intraepithelial neoplasia (CIN2/3). Under the agreement, Roche will lead worldwide development and commercialization. TG 4001 has completed Phase II studies and is in the planning-stage to enter into Phase III studies.
Transgene will receive Euro 13 million as an upfront payment and Euro 10 million as a near-term regulatory milestone payment related to planning the Phase III studies.
Roche may pay Transgene up to Euro 195 million upon the achievement of certain further development and sales-based events in various HPV-related indications. Transgene is also entitled to double-digit escalating royalties on sales once a product is marketed.
Roche will hold all manufacturing rights but has agreed to allocate, on commercial terms, exclusive responsibility to Transgene for the clinical-trial supply of TG 4001 and additional HPV products, which may be developed in the future. This agreement will be extended to commercial-supply manufacturing for an initial period.