Roche pulls out of Papilloma virus deal with Transgene

Swiss drug major Roche (SIX: ROG) has terminated its 2007 agreement under which France’s Transgene (Euronext: FR0005175080), a member of the Institut Merieux Group, granted Roche exclusive global development and commercialization rights to TG4001/RG3484, a therapeutic vaccine candidate to treat notably high grade cervical intraepithelial neoplasia (CIN) lesions (CIN2/3) caused by Human Papilloma Virus infection. TG4001/RG3484 is currently in a Phase IIb clinical trial in this indication.

Roche indicated that its decision is based on its own strategic reasons and is not data driven. Transgene does not expect that the termination to have any impact on the ongoing Phase IIb trial involving 200 patients: with over 195 patients enrolled to date, recruitment in this trial is almost completed and interim data are expected by the end of 2011 or early 2012.

On effective termination this summer, Transgene will regain full and unencumbered development and commercialization rights to TG4001. Transgene does not expect Roche’s decision to have a significant financial impact for the company in the short term. The original deal with Roche provided Transgene with an upfront of 13 million euros, with the potential for additional milestone payments of as much as 195 million euros.