BioWorld International Correspondent

PARIS - Transgene SA and F. Hoffmann-La Roche entered into an exclusive worldwide collaboration to develop and commercialize products derived from Transgene's therapeutic vaccine program against Human Papilloma Virus-mediated diseases. The deal is potentially worth €218 million (US$295 million) to the Strasbourg, France-based gene therapy company.

The Human Papilloma Virus (HPV) is associated with the development of pre-cancerous lesions and cervical cancer, and the agreement covers, among other products, Transgene's lead therapeutic vaccine candidate TG 4001 (MVA-HPV-IL2), which is in clinical development for the treatment of high-grade cervical intraepithelial neoplasia (CIN2/3), a pre-cancerous cervical abnormality that can lead to cervical cancer.

The agreement provides for Roche, of Basel, Switzerland, to take over the worldwide development and commercialization of TG 4001, which has completed Phase II trials. Roche will thus fund all future costs associated with the development of TG 4001 and will lead the Phase III trials, which are already being planned.

Under the agreement, Roche will acquire an exclusive license for TG 4001 and for any other therapeutic vaccine development candidates that result from the collaboration in HPV-mediated diseases, and will have exclusive worldwide commercialization rights. Transgene will receive an up-front payment of €13 million, plus a near-term regulatory milestone of €10 million related to the planning of the Phase III trials.

In addition, Roche could pay Transgene further milestones of up to €195 million at subsequent development and commercialization stages in various HPV-related indications. Transgene also will be entitled to double-digit, escalating royalties on sales of any product brought to market.

Roche will hold all manufacturing rights but has agreed to award an exclusive commercial contract to Transgene for the supply of TG 4001 for clinical trials and of additional HPV products that may be developed in the future. The agreement is to be extended to commercial-supply manufacturing for an initial period.

Welcoming the deal, Transgene's CEO, Philippe Archinard, said "This first strategic partnership is an acknowledgement of the validity of our technology and strategy. It is a considerable transforming event for Transgene that we anticipate will enable us to accelerate and broaden the development of our entire product portfolio."

For his part, Peter Hug, Roche's global head of pharma partnering, pointed out that Transgene offered a "differentiated approach to a pre-cancerous condition with high unmet need." And he added: "Transgene's expertise in viral vaccine therapeutics complements our core capabilities in oncology and virology drug development. In addition, as Roche is a leader in in vitro diagnostics with strong capabilities in HPV detection, our collaboration with Transgene has the potential to expand and evolve into an integrated personalized medicine approach."