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Transgene and Roche enter EUR 218m cervical cancer vaccine alliance

Roche and Transgene have entered into an exclusive worldwide collaboration agreement to develop and commercialise products from Transgeneís human papilloma virus-mediated (HPV) therapeutic vaccine programme

Swiss pharmaceutical firm, Roche, and French gene therapy company, Transgene, have entered into an exclusive worldwide collaboration agreement to develop and commercialise products from Transgeneís human papilloma virus-mediated (HPV) therapeutic vaccine programme.

The agreement, worth a potential EUR 218m, includes Transgeneís lead therapeutic vaccine candidate TG 4001 (MVA-HPV-IL2), currently in clinical development to treat high grade cervical intraepithelial neoplasia, a precancerous cervical abnormality which can develop into cervical cancer.

Per the agreement, Roche will receive an exclusive license for TG 4001 and any further therapeutic vaccine candidates resulting from the collaboration. The company will also own exclusive worldwide commercialisation rights. Roche will fund all future costs associated with the development of TG 4001 and will lead the phase III studies.

Transgene will receive EUR 13m as an upfront payment and EUR 10m as a near-term regulatory milestone payment related to planning the phase III studies. Roche could pay Transgene up to EUR 195m, if further development and sales-based milestones in various HPV-related indications are met. Transgene is also entitled to royalties on sales when 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 could arise in the future. The agreement will be extended to commercial-supply manufacturing for an initial period. TG-4001 could reach the market in 2011, according to Transgeneís CEO, Philippe Archinard.

TG 4001 follows Merckís HPV vaccine, Gardasil, which is already approved in the EU and US markets, and GlaxoSmithKlineís Cervarix vaccine, which could become available as early as 2007.

Analysts see a potential USD 5bn a year market for HPV vaccines. Gardasil has the early advantage since it came to market first. Some analysts say that Merck is intent on inoculating as many girls as possible before the introduction of GSKís product. Sanford C Bernstein analysts project USD 2.5bn in peak annual sales for Gardasil and USD 1.5bn for Cervarix.

Shares in Transgene, which have risen over 50 per cent since the end of 2006 on the news of a potential licensing deal, leapt eight per cent in morning trade on 11 April 2007.

11th April 2007

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