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Roche and Transgene Enter Partnership on Therapeutic Vaccines


-- Roche to develop and commercialize products from Transgene’s program--

Roche and Transgene announced today that they have 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 Human Papilloma Virus (HPV) is associated with the development of precancerous lesions and cancer of the cervix. The agreement includes Transgene’s lead therapeutic vaccine candidate TG 4001 (MVA-HPV-IL2), currently in clinical development to treat high grade cervical intraepithelial neoplasia (CIN2/3), a precancerous cervical abnormality which can lead to cervical cancer. Under the agreement, Roche will lead worldwide development and commercialization. TG 4001 has completed Phase II studies and is in planning for entry into Phase III studies.

‘Transgene is an ideal strategic fit for Roche, offering a differentiated approach to a precancerous condition with high unmet need,’ said Peter Hug, Roche’s Global Head of Pharma Partnering. ‘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. We look forward to working with Transgene on this program.’

‘We are delighted by Roche’s commitment to further develop our promising vaccine TG 4001 in the field of HPV-mediated diseases,’ said Philippe Archinard, Chief Executive Officer of Transgene. ‘Roche has broad expertise and a leadership position in the development and marketing of first-in-class innovative therapies. 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.’

Terms of the Agreement

Roche will acquire an exclusive license for TG 4001 and further therapeutic vaccine development candidates resulting from the collaboration in HPV-mediated diseases, and will have exclusive worldwide commercialization rights. Roche will fund all future costs associated with the development of TG 4001 and will lead the 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 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. In addition, the agreement is subject to clearance by the U.S. Federal Trade Commission under the Hart Scott Rodino Antitrust Improvement Act.


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