The new phase II clinical programme will recruit approximately 200 patients with CIN 2/3 lesions, providing valuable additional clinical data that is expected to strengthen the product’s profile and provide further proof of efficacy. The study is expected to commence in the first half of 2009.
The decision has no bearing on the partnership agreement signed between Roche and Transgene in April 2007 for the development and commercialisation of TG4001/R3484.
Jean-Jacques Garaud, Global Head, Roche Pharma Development, said: “Our decision stems from the desire to optimise the profile definition of TG4001/R3484 prior to entry into phase III by accumulating additional clinical data. We are committed to the product’s future development and believe that by launching a new and larger phase II trial, we will significantly increase the prospects of the product’s future success”.
Philippe Archinard, Chief Executive Officer of Transgene, said: “This decision, which is not based on regulatory requirements, will involve a delay in the product’s future commercialisation. However, we believe that its long term benefits far outweigh any short term considerations. We are confident of our product’s ability to treat diseases caused by the human papilloma virus”.
About the partnership agreement concluded in April 2007
Roche acquired an exclusive license for TG4001/R3484 and further therapeutic vaccine development candidates resulting from the collaboration in HPV-mediated diseases, and has exclusive worldwide commercialization rights. Roche is funding all costs associated with the development of TG4001/R3484 and will lead clinical studies.
Transgene has so far received 23 million Euros in upfront and milestone payments. Roche may pay Transgene up to a total of 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 holds all manufacturing rights but has agreed to allocate, on commercial terms, exclusive responsibility to Transgene for the clinical-trial supply of TG4001/R3484 and additional HPV products, which may be developed in the future. This agreement will be extended to commercial-supply manufacturing for an initial period.
About TG4001/R3484
TG4001/R3484 HPV targeted immunotherapy is designed to target HPV16 and HPV16-related genotypes, known to be a high risk factor for the development of precancerous cervical intraepithelial neoplasia and subsequently cervical cancer.
TG4001/R3484 is based on a non-propagative, highly attenuated vaccinia vector (MVA), which is engineered to express HPV16 antigens and an adjuvant. As an immunotherapy for women diagnosed with diseases caused by the HPV 16 infection, TG4001 is designed to have a two-pronged anti-viral approach: to alert the immune system specifically to HPV16-infected cells that have started to undergo precancerous transformation (cells presenting the HPV16 E6 and E7 antigens) and to further stimulate the infection-clearing activity of the immune system through an adjuvant (interleukin 2).
In Phase II clinical trials, TG4001/R3484 demonstrated safety and promising clinical responses in HPV16 positive women with CIN2/3. Activity of the drug was demonstrated in a phase II trial that was conducted in France in 21 women with HPV16 CIN2/3. No serious side effects were observed. Sustainability of the response was assessed by an examination at Month 12 of the patients who did not undergo surgical excision of CIN lesions at Month 6. No CIN2/3 relapse nor any HPV16 persistence or re-infection were observed in these women.
About Transgene
Transgene is a France-based biopharmaceutical company dedicated to the development of therapeutic vaccines and immunotherapeutic products in oncology and infectious diseases. The company has three compounds in Phase II trials (TG4001/R3484, TG4010 and TG1042) and one compound in Phase I studies (TG4040). Transgene has concluded a strategic partnership agreement with Roche for the development of its TG4001/R3484 immunotherapy product to treat HPV-mediated diseases. Transgene has bio-manufacturing capacities for viral-based vectors and technologies available for out-licensing. Additional information about Transgene is available on the Internet at www.transgene.fr.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion Swiss francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at www.roche.com.
Press Contacts:
For Transgene Transgene Capital MS&L Philippe Archinard, C.E.O Mary Clark Philippe Poncet, C.F.O. Anna Mitchell Phone: +33 3 88 27 91 21 Phone: +44 20 7307 5330 anna.mitchell@capitalmsl.com
Elisabetta Castelli Investors Relations Phone: + 33 1 44 08 55 05
For Roche
Peter Sandbach Roche Pharma Partnering Phone: +41 61 688 3408 peter.sandbach@roche.com
