Roche, Transgene Form Pact Worth Up to 218 Million Euros

Roche and French drugmaker Transgene announced that they have entered into an exclusive worldwide collaboration agreement to develop and commercialize products from Transgene's line of vaccines against human papillomavirus (HPV)-mediated diseases.

The agreement includes Transgene's lead therapeutic vaccine candidate TG 4001, currently in clinical development to treat high grade cervical intraepithelial neoplasia, a precancerous cervical abnormality that can lead to cervical cancer. Under the agreement, Roche will lead worldwide development and commercialization of the product. TG 4001 has completed Phase II studies and will soon enter Phase III studies.

"Transgene is an ideal strategic fit for Roche, offering a differentiated approach to a precancerous condition with high unmet need," Roche's Global Head of Pharma Partnering Peter Hug said. "Transgene's expertise in viral vaccine therapeutics complements our core capabilities in oncology and virology drug development."

Roche will acquire an exclusive license for TG 4001 and other therapeutic candidates resulting from the collaboration in HPV-mediated diseases, and it will have exclusive worldwide commercialization rights. Roche will fund all future costs associated with the development of TG 4001 and will lead Phase III studies.

Transgene will receive 13 million euros as an upfront payment and 10 million euros as a near-term regulatory milestone payment related to planning the Phase III studies. Roche may pay Transgene up to 195 million euros upon the achievement of certain development and sales events in various HPV-related indications. Transgene is also entitled to double-digit escalating royalties on sales once a product is commercialized.